Trokendi Xr

Migraine, Caloric Restriction, High cholesterol + 16 more

Treatment

20 Active Studies for Trokendi Xr

What is Trokendi Xr

Topiramate

The Generic name of this drug

Treatment Summary

Topiramate is an anticonvulsant medication used to treat seizures and prevent migraines. It was first approved by the FDA in 1996. In 2004, it was also approved for the prevention of migraines in adults. Since 2012, it has been approved in combination with phentermine to help adults manage their weight. It has a unique chemical structure and is made up of 40% oxygen. It was created when scientists were trying to create a new diabetes drug.

Topamax

is the brand name

image of different drug pills on a surface

Trokendi Xr Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Topamax

Topiramate

1997

526

Effectiveness

How Trokendi Xr Affects Patients

Topiramate is used to prevent seizures and treat migraine symptoms by decreasing activity in the brain. It may cause dangerous side effects such as metabolic acidosis, mood changes, suicidal thoughts and attempts, and kidney stones. When taken with valproic acid, topiramate can also lead to hypothermia.

How Trokendi Xr works in the body

Seizures are caused by uncontrolled electrical activity in the brain. Topiramate works to reduce this activity in order to treat seizures and migraines. It does this by affecting GABA receptors, which normally inhibit nerve activity, and glutamate receptors, which stimulate activity. By increasing GABA activity and decreasing glutamate activity, topiramate blocks nerve signals from firing, preventing seizures and migraines. It also blocks voltage-dependent sodium channels in the brain, another way of reducing seizure activity. It is also known to affect certain carbonic anhydrase molecules, but we don't know what effect this has yet.

When to interrupt dosage

The prescribed measure of Trokendi Xr is contingent upon the diagnosed state, such as Seizures, Weight Reduction and Tonic - clonic seizures. The amount of dosage can be found in the table below, depending on the administration technique (e.g. Tablet, coated or Tablet).

Condition

Dosage

Administration

Alcoholism

, 25.0 mg, 100.0 mg, 200.0 mg, 50.0 mg, 150.0 mg, 15.0 mg, 23.0 mg, 46.0 mg, 69.0 mg, 92.0 mg, 25.0 meq, 25.0 mg/mL

, Tablet, Oral, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, coated - Oral, Capsule, extended release, Capsule, extended release - Oral, Tablet, coated, Capsule, coated pellets, Capsule, coated pellets - Oral, Capsule, Capsule - Oral, Solution, Solution - Oral

Obesity

, 25.0 mg, 100.0 mg, 200.0 mg, 50.0 mg, 150.0 mg, 15.0 mg, 23.0 mg, 46.0 mg, 69.0 mg, 92.0 mg, 25.0 meq, 25.0 mg/mL

, Tablet, Oral, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, coated - Oral, Capsule, extended release, Capsule, extended release - Oral, Tablet, coated, Capsule, coated pellets, Capsule, coated pellets - Oral, Capsule, Capsule - Oral, Solution, Solution - Oral

Exercise

, 25.0 mg, 100.0 mg, 200.0 mg, 50.0 mg, 150.0 mg, 15.0 mg, 23.0 mg, 46.0 mg, 69.0 mg, 92.0 mg, 25.0 meq, 25.0 mg/mL

, Tablet, Oral, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, coated - Oral, Capsule, extended release, Capsule, extended release - Oral, Tablet, coated, Capsule, coated pellets, Capsule, coated pellets - Oral, Capsule, Capsule - Oral, Solution, Solution - Oral

Lennox Gastaut Syndrome

, 25.0 mg, 100.0 mg, 200.0 mg, 50.0 mg, 150.0 mg, 15.0 mg, 23.0 mg, 46.0 mg, 69.0 mg, 92.0 mg, 25.0 meq, 25.0 mg/mL

, Tablet, Oral, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, coated - Oral, Capsule, extended release, Capsule, extended release - Oral, Tablet, coated, Capsule, coated pellets, Capsule, coated pellets - Oral, Capsule, Capsule - Oral, Solution, Solution - Oral

Migraine

, 25.0 mg, 100.0 mg, 200.0 mg, 50.0 mg, 150.0 mg, 15.0 mg, 23.0 mg, 46.0 mg, 69.0 mg, 92.0 mg, 25.0 meq, 25.0 mg/mL

, Tablet, Oral, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, coated - Oral, Capsule, extended release, Capsule, extended release - Oral, Tablet, coated, Capsule, coated pellets, Capsule, coated pellets - Oral, Capsule, Capsule - Oral, Solution, Solution - Oral

Caloric Restriction

, 25.0 mg, 100.0 mg, 200.0 mg, 50.0 mg, 150.0 mg, 15.0 mg, 23.0 mg, 46.0 mg, 69.0 mg, 92.0 mg, 25.0 meq, 25.0 mg/mL

, Tablet, Oral, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, coated - Oral, Capsule, extended release, Capsule, extended release - Oral, Tablet, coated, Capsule, coated pellets, Capsule, coated pellets - Oral, Capsule, Capsule - Oral, Solution, Solution - Oral

High cholesterol

, 25.0 mg, 100.0 mg, 200.0 mg, 50.0 mg, 150.0 mg, 15.0 mg, 23.0 mg, 46.0 mg, 69.0 mg, 92.0 mg, 25.0 meq, 25.0 mg/mL

, Tablet, Oral, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, coated - Oral, Capsule, extended release, Capsule, extended release - Oral, Tablet, coated, Capsule, coated pellets, Capsule, coated pellets - Oral, Capsule, Capsule - Oral, Solution, Solution - Oral

Obesity

, 25.0 mg, 100.0 mg, 200.0 mg, 50.0 mg, 150.0 mg, 15.0 mg, 23.0 mg, 46.0 mg, 69.0 mg, 92.0 mg, 25.0 meq, 25.0 mg/mL

, Tablet, Oral, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, coated - Oral, Capsule, extended release, Capsule, extended release - Oral, Tablet, coated, Capsule, coated pellets, Capsule, coated pellets - Oral, Capsule, Capsule - Oral, Solution, Solution - Oral

at least one weight-related comorbid condition

, 25.0 mg, 100.0 mg, 200.0 mg, 50.0 mg, 150.0 mg, 15.0 mg, 23.0 mg, 46.0 mg, 69.0 mg, 92.0 mg, 25.0 meq, 25.0 mg/mL

, Tablet, Oral, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, coated - Oral, Capsule, extended release, Capsule, extended release - Oral, Tablet, coated, Capsule, coated pellets, Capsule, coated pellets - Oral, Capsule, Capsule - Oral, Solution, Solution - Oral

Migraine Disorders

, 25.0 mg, 100.0 mg, 200.0 mg, 50.0 mg, 150.0 mg, 15.0 mg, 23.0 mg, 46.0 mg, 69.0 mg, 92.0 mg, 25.0 meq, 25.0 mg/mL

, Tablet, Oral, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, coated - Oral, Capsule, extended release, Capsule, extended release - Oral, Tablet, coated, Capsule, coated pellets, Capsule, coated pellets - Oral, Capsule, Capsule - Oral, Solution, Solution - Oral

Obesity

, 25.0 mg, 100.0 mg, 200.0 mg, 50.0 mg, 150.0 mg, 15.0 mg, 23.0 mg, 46.0 mg, 69.0 mg, 92.0 mg, 25.0 meq, 25.0 mg/mL

, Tablet, Oral, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, coated - Oral, Capsule, extended release, Capsule, extended release - Oral, Tablet, coated, Capsule, coated pellets, Capsule, coated pellets - Oral, Capsule, Capsule - Oral, Solution, Solution - Oral

Seizures

, 25.0 mg, 100.0 mg, 200.0 mg, 50.0 mg, 150.0 mg, 15.0 mg, 23.0 mg, 46.0 mg, 69.0 mg, 92.0 mg, 25.0 meq, 25.0 mg/mL

, Tablet, Oral, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, coated - Oral, Capsule, extended release, Capsule, extended release - Oral, Tablet, coated, Capsule, coated pellets, Capsule, coated pellets - Oral, Capsule, Capsule - Oral, Solution, Solution - Oral

Type 2 Diabetes

, 25.0 mg, 100.0 mg, 200.0 mg, 50.0 mg, 150.0 mg, 15.0 mg, 23.0 mg, 46.0 mg, 69.0 mg, 92.0 mg, 25.0 meq, 25.0 mg/mL

, Tablet, Oral, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, coated - Oral, Capsule, extended release, Capsule, extended release - Oral, Tablet, coated, Capsule, coated pellets, Capsule, coated pellets - Oral, Capsule, Capsule - Oral, Solution, Solution - Oral

Hypertensive disease

, 25.0 mg, 100.0 mg, 200.0 mg, 50.0 mg, 150.0 mg, 15.0 mg, 23.0 mg, 46.0 mg, 69.0 mg, 92.0 mg, 25.0 meq, 25.0 mg/mL

, Tablet, Oral, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, coated - Oral, Capsule, extended release, Capsule, extended release - Oral, Tablet, coated, Capsule, coated pellets, Capsule, coated pellets - Oral, Capsule, Capsule - Oral, Solution, Solution - Oral

Epilepsy

, 25.0 mg, 100.0 mg, 200.0 mg, 50.0 mg, 150.0 mg, 15.0 mg, 23.0 mg, 46.0 mg, 69.0 mg, 92.0 mg, 25.0 meq, 25.0 mg/mL

, Tablet, Oral, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, coated - Oral, Capsule, extended release, Capsule, extended release - Oral, Tablet, coated, Capsule, coated pellets, Capsule, coated pellets - Oral, Capsule, Capsule - Oral, Solution, Solution - Oral

Weight Loss

, 25.0 mg, 100.0 mg, 200.0 mg, 50.0 mg, 150.0 mg, 15.0 mg, 23.0 mg, 46.0 mg, 69.0 mg, 92.0 mg, 25.0 meq, 25.0 mg/mL

, Tablet, Oral, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, coated - Oral, Capsule, extended release, Capsule, extended release - Oral, Tablet, coated, Capsule, coated pellets, Capsule, coated pellets - Oral, Capsule, Capsule - Oral, Solution, Solution - Oral

increase in physical activity

, 25.0 mg, 100.0 mg, 200.0 mg, 50.0 mg, 150.0 mg, 15.0 mg, 23.0 mg, 46.0 mg, 69.0 mg, 92.0 mg, 25.0 meq, 25.0 mg/mL

, Tablet, Oral, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, coated - Oral, Capsule, extended release, Capsule, extended release - Oral, Tablet, coated, Capsule, coated pellets, Capsule, coated pellets - Oral, Capsule, Capsule - Oral, Solution, Solution - Oral

Mood Disorders

, 25.0 mg, 100.0 mg, 200.0 mg, 50.0 mg, 150.0 mg, 15.0 mg, 23.0 mg, 46.0 mg, 69.0 mg, 92.0 mg, 25.0 meq, 25.0 mg/mL

, Tablet, Oral, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, coated - Oral, Capsule, extended release, Capsule, extended release - Oral, Tablet, coated, Capsule, coated pellets, Capsule, coated pellets - Oral, Capsule, Capsule - Oral, Solution, Solution - Oral

Chronic Weight Management therapy

, 25.0 mg, 100.0 mg, 200.0 mg, 50.0 mg, 150.0 mg, 15.0 mg, 23.0 mg, 46.0 mg, 69.0 mg, 92.0 mg, 25.0 meq, 25.0 mg/mL

, Tablet, Oral, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, coated - Oral, Capsule, extended release, Capsule, extended release - Oral, Tablet, coated, Capsule, coated pellets, Capsule, coated pellets - Oral, Capsule, Capsule - Oral, Solution, Solution - Oral

Warnings

Trokendi Xr Contraindications

Condition

Risk Level

Notes

Acidosis

Do Not Combine

There are 20 known major drug interactions with Trokendi Xr.

Common Trokendi Xr Drug Interactions

Drug Name

Risk Level

Description

Abemaciclib

Major

The metabolism of Abemaciclib can be increased when combined with Topiramate.

Acalabrutinib

Major

The metabolism of Acalabrutinib can be increased when combined with Topiramate.

Acenocoumarol

Major

The metabolism of Acenocoumarol can be increased when combined with Topiramate.

Alectinib

Major

The metabolism of Alectinib can be increased when combined with Topiramate.

Alpelisib

Major

The metabolism of Alpelisib can be increased when combined with Topiramate.

Trokendi Xr Toxicity & Overdose Risk

Rats have been found to tolerate doses of up to 1500mg/kg of topiramate. In humans, overdosing on topiramate can cause symptoms ranging from mild to severe, such as low blood pressure, extreme acidosis, abdominal pain, seizures, confusion, dizziness, depression, and more. To treat an overdose, doctors may induce vomiting, give activated charcoal, or use dialysis.

image of a doctor in a lab doing drug, clinical research

Trokendi Xr Novel Uses: Which Conditions Have a Clinical Trial Featuring Trokendi Xr?

At present, there are 313 active trials investigating the potential of Trokendi Xr to address Type 2 Diabetes, Migraine and Exercise-associated conditions.

Condition

Clinical Trials

Trial Phases

Exercise

60 Actively Recruiting

Not Applicable, Phase 2

Weight Loss

1 Actively Recruiting

Not Applicable

Mood Disorders

0 Actively Recruiting

Migraine

52 Actively Recruiting

Phase 4, Phase 1, Not Applicable, Phase 3, Phase 2, Early Phase 1

Obesity

0 Actively Recruiting

Chronic Weight Management therapy

0 Actively Recruiting

Migraine Disorders

1 Actively Recruiting

Phase 3

Hypertensive disease

41 Actively Recruiting

Not Applicable, Phase 3, Phase 1, Phase 2

Seizures

4 Actively Recruiting

Phase 3, Phase 2, Phase 1

High cholesterol

0 Actively Recruiting

Obesity

0 Actively Recruiting

at least one weight-related comorbid condition

0 Actively Recruiting

Lennox Gastaut Syndrome

10 Actively Recruiting

Phase 4, Phase 3, Phase 2, Phase 1, Not Applicable

Obesity

0 Actively Recruiting

Caloric Restriction

0 Actively Recruiting

Epilepsy

10 Actively Recruiting

Not Applicable, Phase 4, Early Phase 1, Phase 1

Alcoholism

5 Actively Recruiting

Phase 2, Phase 3, Not Applicable

Type 2 Diabetes

184 Actively Recruiting

Not Applicable, Phase 2, Phase 4, Phase 1, Early Phase 1, Phase 3

increase in physical activity

0 Actively Recruiting

Trokendi Xr Reviews: What are patients saying about Trokendi Xr?

5

Patient Review

1/16/2020

Trokendi Xr for Migraine Prevention

I was 60 when I developed cluster headaches. tried Topamax regular and had the same side effects as others have described. My neuro switched me to the 25mg XR, and no more side effects, and about 1 cluster headache per year now.

4.7

Patient Review

11/13/2017

Trokendi Xr for Migraine Prevention

I've only had one migraine in the five months since I started this treatment, which is amazing because I was getting them two to three times a week previously. .25m at night does the trick for me with no negative side effects that I can tell.

4.3

Patient Review

1/10/2018

Trokendi Xr for Essential Tremor

Trokendi XR was recommended to me by my doctor, and I'm glad I gave it a try. After trying out different strengths, I found that the 50mg dosage worked best for me in terms of reducing hand shaking and other symptoms. The generic version didn't work as well for me, so be aware of that when you're considering this drug.

2.3

Patient Review

5/31/2018

Trokendi Xr for Migraine Prevention

At first, this medication seemed to help. I increased the dosage from 25mg to 50mg to 100mg. However, at 100mg I felt completely useless and bedridden. Tingling in my fingers and feet was a constant issue throughout the entire process. Now that I'm stopping the medication, I'm experiencing bone pain, tingling fingers and feet, frequent urination, back pain, and signs of kidney stones – all considered serious side effects.

1.7

Patient Review

11/29/2021

Trokendi Xr for Migraine Prevention

Dizziness, slurred speech, short term memory loss, no energy, loss of appetite, forgetful, frequent urination with incontence, hair breaking/ loss, very brittle finger / toe nails, increase headaches. These are just some of the issues I experienced while taking this medication. Please do not take it. I went cold turkey and after a bit more than two weeks felt so much better. Also able to start managing my life again.

1

Patient Review

5/12/2018

Trokendi Xr for Migraine Prevention

I have only been taking Trokendi for a short while, but it has already caused me serious problems. I started hallucinating a few hours after taking the medication, and it has made my speech slurred and walking difficult. I will be asking my neurologist to take me off this med as soon as possible. It also is not helping my migraines at all and has given me terrible acne.

1

Patient Review

1/10/2020

Trokendi Xr for Migraine Prevention

I was taking topiramate 25mg twice daily and it helped reduce my migraines to about 2-3 per month. However, when my neuro prescribed Trokendi XR at 25mg and then 50mg, my migraines came back with a vengeance. I'm going back on the topiramate soon if things don't improve.

1

Patient Review

5/10/2021

Trokendi Xr for Migraine Prevention

This medication was extremely dangerous and almost killed me. I lost 30 pounds as a result of taking it, and my BP plummeted to 53/30. I also developed neuropathy in both hands (which is now permanent) and suffered from fatigue, hair loss, and nail loss. This medication ruined my life and I would urge anyone considering taking it to avoid doing so at all costs.

1

Patient Review

9/10/2021

Trokendi Xr for Migraine Prevention

The side effects were really intense and debilitating. I felt constantly dizzy, my speech was slurred, and I had a lot of trouble concentrating or thinking clearly. On top of all that, I also experienced extreme anxiety. Luckily, I only lost 12 pounds in the two weeks that I took this medication.

1

Patient Review

4/15/2019

Trokendi Xr for Migraine Prevention

I had terrible side effects that began after only six weeks of taking the medication. I was constantly feeling low, exhausted, and anxious. If you have any history of mental illness or depression, I would not recommend this drug. It made me feel insane. Within two days of stopping the medication, most of the side effects dissipated. However, I still suffer from migraines on a daily basis.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about trokendi xr

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does Trokendi XR make you sleepy?

"Trokendi may cause tiredness, sleepiness, drowsiness, dizziness, changes in vision, and slowed reactions. The use of alcohol with Trokendi may increase these side effects."

Answered by AI

What is Trokendi XR used for?

"Trokendi XR is a prescription medicine that is used to prevent migraines in adults and adolescents who are at least 12 years old. It is also used to treat certain types of seizures in people who are at least 6 years old."

Answered by AI

Is Trokendi XR the same as Topamax?

"Both drugs contain the same active ingredient called topiramate. Trokendi XR comes as an extended-release (long-acting) oral capsule and Topamax come as an immediate-release tablet or capsule. Trokendi XR is taken once a day, while Topamax is usually taken twice a day, in the morning and evening."

Answered by AI

Is Trokendi XR used for weight loss?

"While Trokendi XR is not approved as a weight loss medication, it is common for patients to lose weight while taking the drug, especially at higher doses. Your doctor may prescribe Trokendi XR off-label for binge eating disorder. If you have questions about Trokendi XR and weight loss, speak with your doctor."

Answered by AI

Clinical Trials for Trokendi Xr

Image of University of Cincinnati Medical Center in Cincinnati, United States.

Continuous Glucose Monitoring for Type 2 Diabetes

18+
All Sexes
Cincinnati, OH

The TRANSITION-CGM trial will evaluate whether starting continuous glucose monitoring (CGM) before hospital discharge improves blood glucose control in adults with type 2 diabetes compared with usual care using finger-stick blood glucose checks. The study focuses on the transition from hospital to home, when patients may face changes in diabetes medications and challenges managing their blood glucose levels. This single-center, randomized controlled trial will enroll approximately 218 adults with type 2 diabetes, a hemoglobin A1c (HbA1c) 9% and above, and treatment with insulin and/or oral diabetes medications. Participants will be recruited during hospitalization and must be expected to return home after discharge. People already using a CGM will not be eligible. Participants will be randomly assigned in equal numbers to one of two groups. The CGM group will start using a continuous glucose monitor before discharge and receive device training and written instructions. The usual-care group will continue finger-stick blood glucose monitoring and receive standard discharge education. Both groups will receive assistance with outpatient diabetes follow-up. Diabetes medications will be managed by treating clinicians according to usual clinical practice. Participants will be followed for approximately 12 weeks after discharge, with an early follow-up encounter and a final assessment at 12 weeks. The primary outcome is HbA1c at 12 weeks, a blood test that reflects average blood glucose levels over approximately three months. Secondary outcomes include diabetes-related hospitalizations and episodes of low blood sugar. Additional exploratory measures include CGM use, follow-up attendance, patient-reported experiences, and time spent within the target glucose range when CGM data are available. The study will determine whether initiating CGM during hospitalization can improve glycemic control after discharge and provide preliminary evidence about its effects on diabetes-related hospitalizations and hypoglycemia.

Waitlist Available
Has No Placebo

University of Cincinnati Medical Center

Arunab H Mehta, MD, MEd

Image of Harvard T.H. Chan School of Public Health in Boston, United States.

Healthy Child Care Program for Nutrition and Physical Activity

2 - 5
All Sexes
Boston, MA

The goal of this cluster-randomized, controlled trial is to learn if a professional development program for childcare educators, called the Boston Healthy Child Care Initiative, can help improve the nutritional quality of meals/snacks served and the availability of physical activity opportunities in childcare programs, and also to learn if this results in improved diet quality and physical activity for young children who attend childcare, especially in under-resourced settings. The main questions it aims to answer are: Do childcare programs that receive professional development through the Boston Healthy Child Care Initiative improve the nutritional quality of the meals they serve, as measured by the Healthy Eating Index (HEI-2020), and do they also provide more physical activity opportunities to young children throughout the day? Do young children (ages 2-5 years) attending childcare programs that receive the Boston Healthy Child Care Initiative eat more nutritious foods/beverages (as measured by the HEI-2020) and engage in less sedentary time at childcare? Researchers will compare a group of childcare programs who participate in the Boston Healthy Child Care Initiative, and a sample of children who attend those programs, to a similar group of childcare programs who do not participate to see if the quality of meals served, the amounts of physical activity opportunities scheduled, young children's dietary quality, and the minutes/day spent in physical activity increase from before to after the Boston Healthy Child Care Initiative. Childcare educator participants will: * Complete the Boston Healthy Child Care Initiative professional development program (for the intervention group only) * Share copies of menus, schedules, and written policies about nutrition and physical activity in the childcare program Child participants will: * Wear ActiGraph wGT3X-BT accelerometers for two days while at childcare to measure physical activity levels. They will do this for two days each at baseline, midline, and follow-up after the initiative concludes. * Be observed during mealtimes by trained researchers to visually estimate how much they consume at meals and snacks in childcare.

Waitlist Available
Has No Placebo

Harvard T.H. Chan School of Public Health

Erica L Kenney, ScD, MPH

Have you considered Trokendi Xr clinical trials?

We made a collection of clinical trials featuring Trokendi Xr, we think they might fit your search criteria.
Go to Trials
Image of Penn Medicine, 3535 Market St. in Philadelphia, United States.

Financial Counseling and Health Reviews for Chronic Illness Management

18+
All Sexes
Philadelphia, PA

Among adults with chronic illnesses like hypertension, diabetes, or HIV, adherence to daily oral medications is essential but often below 50%. Why do medication adherence and preventive health service engagement remain stubbornly low? Scarcity theory offers a novel explanation in the context of poverty. It posits that economic hardship imposes a cognitive burden that shifts attention from long-term goals to immediate needs, reduces future orientation (the relative value placed on immediate vs. future outcomes), and limits mental bandwidth (the cognitive resources needed for decisions), thus undermining behaviors like daily medication adherence and service engagement. To address these gaps, the study's objective is to rigorously test whether and how economic scarcity affects medication adherence and preventive service uptake among older adults with chronic disease, leveraging the naturally occurring monthly fluctuation in scarcity created by the Supplemental Nutrition Assistance Program (SNAP) benefit cycle as a natural experiment. There are three aims: 1. Daily medication adherence will be measured objectively for four months with wireless electronic pill bottle caps (CleverCaps). The investigators will test whether, when, and by how much adherence changes as scarcity fluctuates during the SNAP benefit cycle. 2. The investigators will conduct two easily implementable RCTs to test whether scarcity affects participants' engagement with beneficial services requiring navigation of administrative burdens. In one trial, participants will be randomized to receive an invitation during either a high- or low- scarcity period (i.e., before vs. after SNAP receipt) to a personalized preventive health review that identifies gaps in US Preventive Services Task Force Grade A/B recommendations. In the second, participants will be invited to free financial counseling provided by the City of Philadelphia during a high- or low-scarcity period. The investigators hypothesize invitation response rates will be \>15% higher during low-scarcity periods. 3. Potential mechanisms that link scarcity with health behaviors will be examined by randomizing timing of validated measures of mental bandwidth and future orientation during a period of high- or low-scarcity (i.e., before vs. after SNAP receipt). The investigators hypothesize that there will be differences in several measures between participants who are randomly assessed during high- vs. low-scarcity periods (i.e. before vs. after SNAP receipt). Impact: Demonstrating that scarcity helps to explain low medication adherence and beneficial health-related service uptake can inform patient-centered adherence interventions, clinical care-delivery approaches, health-system strategies, and public health approaches to improve these health behaviors and promote healthy aging.

Waitlist Available
Has No Placebo

Penn Medicine, 3535 Market St.

Image of Cedars-Sinai Medical Center in Los Angeles, United States.

Barber and Pharmacist Coordination for High Blood Pressure

35 - 79
Male
Los Angeles, CA

The original, "Cut Your Pressure Too: The LA Barbershop Blood Pressure Study (LABBPS)" (NCT02321618) was a highly successful cluster-randomized trial of a community centered blood pressure (BP) reduction program focused on Non-Hispanic (NH) black men who experience the highest rates of hypertension (HTN) and its complications. Patrons of 52 barbershops in Los Angeles County were randomly assigned to either an intervention arm in which barbers encouraged meetings with trained clinical pharmacists who provided HTN treatment in the barbershops or a control arm in which barbers provided educational pamphlets on HTN and encouraged physician appointments. After 6 months, the intervention group had a statistically significant reduction in systolic BP (SBP) of 21.6 mmHg compared to the control group. Results were durable at 1 year. Thereafter, a pilot study (NCT03726710) aimed at improving the efficiency of the barbershop model of HTN care by substituting in-person visits with video visits once BP was at goal was undertaken in 10 hypertensive barbershop patrons. The intervention effect was unchanged. The current study represents Aim 3 of an NIH funded renewal application entitled, "Barber and Pharmacist Coordination to Improve Blood Pressure Management in Black Men." It will build upon the foundational work of the original study and telemedicine pilot by evaluating the efficacy of a fully remote hypertension management program.

Waitlist Available
Has No Placebo

Cedars-Sinai Medical Center

Christine Albert, MD, MPH

Have you considered Trokendi Xr clinical trials?

We made a collection of clinical trials featuring Trokendi Xr, we think they might fit your search criteria.
Go to Trials
Image of Foothills Medical Center in Calgary, Canada.

Spinal Cord Stimulation for High Blood Pressure

18+
All Sexes
Calgary, Canada

High blood pressure, also called hypertension, raises the risk of heart disease, stroke, and kidney disease. Medications work well for many people, but some people still have blood pressure that stays too high, or they have side effects from their medications. Researchers are looking for treatments that do not involve taking more medication. Nerves help control blood pressure by changing how blood vessels tighten and how hard the heart pumps. Because of this, treatments that act on nerves may be able to lower blood pressure. Spinal cord stimulation is a treatment already used to manage long-term pain. It uses a small device, placed under the skin during a standard operation, that sends mild electrical signals to the spine. Laboratory studies suggest that stimulating the lower part of the mid-back may also lower blood pressure, but this has not been carefully studied in people who already use these devices. This study will look at whether changing the settings on a spinal cord stimulator affects blood pressure. About 11 adults who have high blood pressure and who already have a spinal cord stimulator for long-term pain. No new device will be placed, and no surgery or other invasive procedure will be done for this study. Participants attend a series of study visits. At each visit, trained staff record blood pressure and heart rate while the stimulator is turned on, turned off, and set to other settings that the person's care team has approved and that the person finds comfortable. There are rest breaks between each setting. Over successive visits, the study team works to identify the settings that best lower blood pressure. Participants can stop at any time, and their usual settings are restored at the end of each visit. The study will also look at whether this kind of testing is practical and comfortable for participants. The results will help researchers decide whether larger studies of spinal cord stimulation for blood pressure control are worth doing.

Waitlist Available
Has No Placebo

Foothills Medical Center

Aaron Phillips, PhD

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Remote Electrical Neuromodulation for Migraine

18+
All Sexes
Bridgewater, NJ

Migraine and Fibromyalgia (FM) are chronic pain disorders characterized by altered central pain processing and impaired endogenous pain inhibition. FM presents with widespread musculoskeletal pain, fatigue, sleep disturbance, and cognitive symptoms and is strongly associated with central sensitization. Migraine similarly involves dysfunction of central inhibitory and descending pain modulation, with evidence of abnormal cortical excitability, impaired sensory habituation, and alterations in pain-related evoked potentials. Conditioned Pain Modulation (CPM) is a measure of the body's endogenous pain-inhibitory mechanism, based on the phenomenon whereby the pain evoked by one painful stimulus (the test stimulus) is reduced by the concurrent application of a second, remote nociceptive stimulus (the conditioning stimulus). It is widely regarded as a proxy for the function of descending pain-modulatory pathways. CPM is used as an experimental biomarker of descending pain inhibition across chronic pain conditions, including fibromyalgia and migraine. Studies consistently demonstrate reduced inhibitory responses in both migraine and fibromyalgia compared with healthy controls, indicating a robust deficit in descending pain modulatory systems. Combining a contact heat test stimulus (TS) with a cold pressor conditioning stimulus (CS) is a widely used and validated CPM paradigm. Nerivio, a Remote Electrical Neuromodulation (REN) device, is a non-invasive, non-pharmacological therapy indicated for the acute and preventive treatment of migraine. The REN device is worn on the upper arm and delivers peripheral electrical stimulation to activate CPM-related descending inhibitory pathways and reduce migraine pain. This distal stimulation approach is designed to activate CPM-related circuits by recruiting brainstem pain-regulatory centers and modulating central nociceptive processing. This randomized, double-blind, placebo-controlled trial is designed to assess the effect of a single REN session on CPM and cortical pain processing in adults with migraine or fibromyalgia. Using a standardized CPM induction protocol, the study will evaluate changes in behavioral CPM responses, before, during, and after REN vs. sham stimulation in patients with migraine or fibromyalgia. This study aims to clarify whether REN enhances descending pain inhibition and pain processing in populations with impaired endogenous pain modulation.

Recruiting
Online Trial

Theranica Bio-Electronics Inc

Alit Stark Inbar, PhD

Theranica

Image of University of Southern California in Los Angeles, United States.

Activity and Self-Regulation for Binge Eating Disorder in Children

10 - 12
All Sexes
Los Angeles, CA

Loss of control eating in children and adolescents is associated with a host of negative physical and psychological health outcomes and a prognostic marker for development of eating disorders. However, there is a lack of longitudinal research investigating the developmental processes contributing to loss of control eating in youth. While physical activity, sedentary behavior, and self-regulation have been linked to the regulation of eating, no research has examined the mechanistic processes by which these domains may together impact loss of control eating during childhood and adolescence. Furthermore, given that these factors (i.e., activity, self-regulation, and eating behavior) vary considerably from moment-to-moment, it is imperative to utilize methodology that can capture momentary, real-time fluctuations in these domains. Therefore, the current study proposes to use a biobehavioral, multi-method approach integrating neuroimaging, accelerometry, neurocognitive assessments, and ecological momentary assessment (EMA) to study how physical activity and sedentary behavior patterns and self-regulation influence loss of control eating and related eating disorder psychopathology from late childhood to adolescence, which is a critical transitional developmental period. Male and female children aged 10-12 at baseline (N=200) will be recruited to complete annual assessments for 3 years. Aim 1 (momentary) - Examine momentary associations between physical activity patterns, self-regulatory mechanisms (i.e., inhibitory control, emotion functioning, and food-related reward anticipation) and loss of control eating in daily life using multi-method ambulatory assessment. Hypothesis 1a: Momentary decreases in physical activity and increases in sedentary behavior, compared to one's usual level, will be associated with increases in loss of control eating. Hypothesis 1b: Momentary decreases in self-regulatory mechanisms (i.e., decreases in inhibitory control, emotion regulation, and positive affect, and increases in negative affect and food-related reward anticipation) will explain (i.e., mediate) associations between decreases in physical activity/increases in sedentary behavior and subsequent increases in loss of control eating. Aim 2 (longitudinal) - Examine longitudinal associations between physical activity patterns, self-regulatory mechanisms, and binge eating and related eating pathology (i.e., loss of control eating, binge episodes, eating disorder onset, global eating psychopathology) using multimethod ambulatory assessment and functional magnetic resonance imaging (fMRI). Hypothesis 2: Across a three-year follow-up, children who show greater decreases in physical activity and increases in sedentary behavior, compared to other children, will demonstrate greater decreases in self-regulatory capacity (i.e., decreases in inhibitory control, emotion regulation, and positive affect, and increases in negative affect and food-related reward anticipation), which in turn will predict increases in binge eating and related eating pathology by year three. The hypothesis will be evaluated using self-regulation indices measured via EMA (Hypothesis 2a) and via task-evoked neural activations during fMRI (Hypothesis 2b).

Waitlist Available
Has No Placebo

University of Southern California (+2 Sites)

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