Pregabalin

Seizures, Peripheral Nervous System Diseases, Generalized Anxiety Disorder + 9 more

Treatment

12 FDA approvals

20 Active Studies for Pregabalin

What is Pregabalin

Pregabalin

The Generic name of this drug

Treatment Summary

Pregabalin is a medication used to treat nerve pain, shingles pain, and fibromyalgia. It works by affecting the levels of a chemical called GABA, which is a neurotransmitter that helps with pain signals. The exact way that pregabalin works is not fully understood, but it is believed to bind to a subunit of voltage-dependent calcium channels in the brain. Pregabalin is sold under the brand name Lyrica and Lyrica CR (extended release). Using pregabalin irresponsibly or in large doses can cause dependence, particularly in people with a history of substance abuse.

Lyrica

is the brand name

image of different drug pills on a surface

Pregabalin Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Lyrica

Pregabalin

2004

579

Approved as Treatment by the FDA

Pregabalin, also called Lyrica, is approved by the FDA for 12 uses which include Neuropathic Pain and Diabetic Peripheral Neuropathic Pain (DPN) .

Neuropathic Pain

Helps manage Neuropathic Pain

Diabetic Peripheral Neuropathic Pain (DPN)

Helps manage Diabetic Peripheral Neuropathic Pain (DPN)

Neuropathic Pain

Helps manage Neuropathic Pain

Seizures

Diabetic Neuralgia

Helps manage Diabetic Peripheral Neuropathic Pain (DPN)

Postherpetic Neuralgia

Partial-Onset Seizures

Spinal Cord Injuries (SCI)

Helps manage Spinal Cord Injuries (SCI)

Fibromyalgia (FM)

Helps manage Fibromyalgia (FM)

Spinal Cord Injury

Helps manage Spinal Cord Injuries (SCI)

Neuralgia, Postherpetic

Fibromyalgia

Helps manage Fibromyalgia (FM)

Effectiveness

How Pregabalin Affects Patients

Pregabalin is structurally similar to gamma-aminobutyric acid (GABA) but does not bind to GABA receptors. Instead, it attaches itself to calcium channels in the brain which helps reduce the amount of pain signals that are sent out. It does not influence dopamine, serotonin, opiate receptors, sodium channels, or the enzyme cyclooxygenase.

How Pregabalin works in the body

We don't know exactly how pregabalin works, but it appears to bind to voltage-gated calcium channels in the central nervous system. This connection helps reduce the amount of excitatory neurotransmitters, like glutamate and norepinephrine, that are released. It also prevents the alpha2-delta subunit from being transported to the spinal dorsal horn. Pregabalin is related to GABA, but it does not bind directly to GABA or benzodiazepine receptors.

When to interrupt dosage

The advised dose of Pregabalin is contingent upon the declared ailment, such as Neuralgia, Fibromyalgia and Postherpetic Neuralgia. The measure can be seen in the table below, in accordance with the method of delivery (e.g. Capsule or Tablet, film coated, extended release).

Condition

Dosage

Administration

Vitamin B 12 Deficiency

, 50.0 mg, 25.0 mg, 75.0 mg, 100.0 mg, 150.0 mg, 200.0 mg, 300.0 mg, 225.0 mg, 20.0 mg/mL, 165.0 mg, 82.5 mg, 330.0 mg

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

Neuropathic Pain

, 50.0 mg, 25.0 mg, 75.0 mg, 100.0 mg, 150.0 mg, 200.0 mg, 300.0 mg, 225.0 mg, 20.0 mg/mL, 165.0 mg, 82.5 mg, 330.0 mg

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

Epilepsy

, 50.0 mg, 25.0 mg, 75.0 mg, 100.0 mg, 150.0 mg, 200.0 mg, 300.0 mg, 225.0 mg, 20.0 mg/mL, 165.0 mg, 82.5 mg, 330.0 mg

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

No gastrointestinal absorption problems

, 50.0 mg, 25.0 mg, 75.0 mg, 100.0 mg, 150.0 mg, 200.0 mg, 300.0 mg, 225.0 mg, 20.0 mg/mL, 165.0 mg, 82.5 mg, 330.0 mg

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

Neuralgia

, 50.0 mg, 25.0 mg, 75.0 mg, 100.0 mg, 150.0 mg, 200.0 mg, 300.0 mg, 225.0 mg, 20.0 mg/mL, 165.0 mg, 82.5 mg, 330.0 mg

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

Spinal Cord Injury

, 50.0 mg, 25.0 mg, 75.0 mg, 100.0 mg, 150.0 mg, 200.0 mg, 300.0 mg, 225.0 mg, 20.0 mg/mL, 165.0 mg, 82.5 mg, 330.0 mg

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

Neuralgia, Postherpetic

, 50.0 mg, 25.0 mg, 75.0 mg, 100.0 mg, 150.0 mg, 200.0 mg, 300.0 mg, 225.0 mg, 20.0 mg/mL, 165.0 mg, 82.5 mg, 330.0 mg

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

Seizures

, 50.0 mg, 25.0 mg, 75.0 mg, 100.0 mg, 150.0 mg, 200.0 mg, 300.0 mg, 225.0 mg, 20.0 mg/mL, 165.0 mg, 82.5 mg, 330.0 mg

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

Generalized Anxiety Disorder

, 50.0 mg, 25.0 mg, 75.0 mg, 100.0 mg, 150.0 mg, 200.0 mg, 300.0 mg, 225.0 mg, 20.0 mg/mL, 165.0 mg, 82.5 mg, 330.0 mg

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

Diabetic Neuralgia

, 50.0 mg, 25.0 mg, 75.0 mg, 100.0 mg, 150.0 mg, 200.0 mg, 300.0 mg, 225.0 mg, 20.0 mg/mL, 165.0 mg, 82.5 mg, 330.0 mg

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

Fibromyalgia

, 50.0 mg, 25.0 mg, 75.0 mg, 100.0 mg, 150.0 mg, 200.0 mg, 300.0 mg, 225.0 mg, 20.0 mg/mL, 165.0 mg, 82.5 mg, 330.0 mg

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

Peripheral Nervous System Diseases

, 50.0 mg, 25.0 mg, 75.0 mg, 100.0 mg, 150.0 mg, 200.0 mg, 300.0 mg, 225.0 mg, 20.0 mg/mL, 165.0 mg, 82.5 mg, 330.0 mg

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

Warnings

Pregabalin Contraindications

Condition

Risk Level

Notes

Severe Hypersensitivity Reactions

Do Not Combine

Pregabalin may interact with Pulse Frequency

There are 20 known major drug interactions with Pregabalin.

Common Pregabalin Drug Interactions

Drug Name

Risk Level

Description

Azelastine

Major

Pregabalin may increase the central nervous system depressant (CNS depressant) activities of Azelastine.

Ethanol

Major

Pregabalin may increase the central nervous system depressant (CNS depressant) activities of Ethanol.

Hydroxyzine

Major

The risk or severity of QTc prolongation can be increased when Pregabalin is combined with Hydroxyzine.

Lorazepam

Major

The risk or severity of adverse effects can be increased when Pregabalin is combined with Lorazepam.

Mobocertinib

Major

The risk or severity of QTc prolongation can be increased when Pregabalin is combined with Mobocertinib.

Pregabalin Toxicity & Overdose Risk

Pregabalin has been linked to a range of side effects affecting the central nervous system and cognition, such as dizziness, balance problems, confusion, sleepiness, tremors, difficulty concentrating, tiredness, and euphoria. When taken in high doses (up to 11,500 mg), the most common symptoms of overdose include sleepiness, confusion, restlessness, agitation, depression, and seizures. There is no antidote for pregabalin overdose, so general supportive care should be given. In severe cases, unabsorbed pregabalin may be eliminated with methods such as gastric lavage or emesis, or

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

Pregabalin Novel Uses: Which Conditions Have a Clinical Trial Featuring Pregabalin?

111 active trials are currently in progress to investigate the potential of Pregabalin for alleviating Peripheral Neuropathy, Postherpetic Neuralgia and Gastrointestinal Absorption Difficulties.

Condition

Clinical Trials

Trial Phases

Spinal Cord Injury

83 Actively Recruiting

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

Diabetic Neuralgia

3 Actively Recruiting

Phase 2, Phase 3

Peripheral Nervous System Diseases

2 Actively Recruiting

Not Applicable

Generalized Anxiety Disorder

11 Actively Recruiting

Not Applicable, Phase 2, Phase 3, Phase 1

Epilepsy

0 Actively Recruiting

Vitamin B 12 Deficiency

0 Actively Recruiting

Fibromyalgia

0 Actively Recruiting

No gastrointestinal absorption problems

0 Actively Recruiting

Seizures

4 Actively Recruiting

Phase 3, Phase 2, Phase 1

Neuralgia

0 Actively Recruiting

Neuralgia, Postherpetic

0 Actively Recruiting

Neuropathic Pain

4 Actively Recruiting

Not Applicable, Phase 1, Phase 2

Pregabalin Reviews: What are patients saying about Pregabalin?

5

Patient Review

5/12/2022

Pregabalin for Nerve Pain from Spinal Cord Injury

I've been dealing with pain from my L1-L3 fracture for 40 years, and this is the first time I've had medication that's really helped. It's allowed me to get off of heroin and finally live a somewhat normal life. The weight gain and clumsiness are unfortunate side effects, but they're worth it to be able to function without constant pain.

5

Patient Review

6/1/2022

Pregabalin for Neuropathic Pain

Without this medication, I would be unable to walk due to the severe neuropathy from diabetes that I have. This has been a lifesaver for me, allowing me to live relatively normally despite my chronic condition.

5

Patient Review

5/12/2022

Pregabalin for Nerve Pain from Spinal Cord Injury

I've been dealing with a lot of pain for 40 years, ever since I fractured my L1-L3 vertebrae. I'm currently taking 300 mg of Pregabalin, 2 15 mg OxyContin, and 1 1mg alprozolam. These have finally helped me manage the pain and live a relatively normal life. Yes, there are some side effects like weight gain and clumsiness, but they're nothing compared to the alternative of living in constant pain.

5

Patient Review

5/19/2022

Pregabalin for Neuropathic Pain

After my stroke, I was left with intense neuropathic pain. This medication has been a godsend in terms of relief, though I find that the effect wears off after a while. Still, it's better than nothing.

5

Patient Review

6/1/2022

Pregabalin for Neuropathic Pain

This medication has been integral to me being able to walk, due to the severe neuropathy I experience from diabetes and multiple foot surgeries.

5

Patient Review

5/19/2022

Pregabalin for Neuropathic Pain

After my stroke, I was in a lot of pain from neuropathy. The previous medication I was on stopped being effective, so I switched to Lyrica. It's been really helpful in managing the pain and has allowed me to get some relief.

4.3

Patient Review

5/15/2022

Pregabalin for Neuropathic Pain

My foot and toes were in a lot of pain before I started this treatment, but I immediately felt relief. Recently, though, the pain has been coming back, so I've had to up my dosage. That's why I'm on this page, doing research to see how much more I can take.

4.3

Patient Review

6/23/2022

Pregabalin for Neuropathic Pain

I've been using this medication for about a week now, and I've found that it offers me pain relief for around four to five hours. The first two of those hours are the strongest in terms of pain reduction, but even the last few hours offer some significant benefits. Additionally, this drug has helped to reduce my anxiety and cravings for cigarettes. So far, no negative side effects to report – though I am planning on discussing an increase in dosage with my doctor given that I still feel sharp pains in my arm from time to time.

4.3

Patient Review

5/15/2022

Pregabalin for Neuropathic Pain

I was in a lot of pain in my left foot and toes. This treatment really helped me, but I've had to up the dosage lately. I'm looking for more information on how much I can take.

4.3

Patient Review

6/23/2022

Pregabalin for Neuropathic Pain

This medication provides me with approximately four to five hours of pain relief, which is definitely welcome. I haven't experienced any negative side effects yet, but I'm going to ask my doctor about increasing the dosage because I can still feel some sharp pains in my arm.

4

Patient Review

7/18/2022

Pregabalin for Nerve Pain from Spinal Cord Injury

I take 75mg at night to help ease nerve pain in my leg from a spinal stenosis. It provides around 6 hours of relief which enables me to sleep. I'm really happy with this product and how it's helped me manage my pain.

4

Patient Review

7/18/2022

Pregabalin for Nerve Pain from Spinal Cord Injury

This medication helps me a lot with the pain I experience from my spinal stenosis. It eases the nerve pain in my leg and allows me to sleep for around six hours.

3.7

Patient Review

6/9/2022

Pregabalin for Nerve Pain from Spinal Cord Injury

I've been using this treatment for years to help with my back problems and neuropathy. It works pretty well, all things considered.

3.7

Patient Review

6/9/2022

Pregabalin for Nerve Pain from Spinal Cord Injury

I've been using this treatment for years to help with my back pain and neuropathy. It works well, but isn't a cure-all.

2.7

Patient Review

6/22/2022

Pregabalin for Neuropathic Pain

I was dealing with a lot of pain in my back and legs due to a bulging disc. Unfortunately, this product didn't do anything to help relieve that pain.

2.7

Patient Review

6/22/2022

Pregabalin for Neuropathic Pain

I didn't find this product effective at all in treating my muscle spasms caused by a bulging disc.

2.3

Patient Review

5/17/2022

Pregabalin for Neuropathic Pain

The first dose was great, but I didn't feel like it worked as well after that. I kept taking it, hoping it would help, but alas, I saw no difference.

2.3

Patient Review

5/17/2022

Pregabalin for Neuropathic Pain

The first dose was great, but I didn't see any difference after that. Started taking ALA afterwards in the hopes that it would help.

2

Patient Review

4/10/2022

Pregabalin for Disorder characterized by Stiff, Tender & Painful Muscles

I found that this medication really impacted my memory and made it hard to concentrate. My appetite also increased quite a bit while I was taking it.

2

Patient Review

4/10/2022

Pregabalin for Disorder characterized by Stiff, Tender & Painful Muscles

I found that this medication really decreased my ability to concentrate and remember things. My appetite also increased quite a bit while I was taking it.

1.3

Patient Review

8/17/2022

Pregabalin for Nerve Pain from Spinal Cord Injury

I was advised to take one pill, then two if one did not work and then max at three. One did nothing, two did not reduce the pain but I felt like I had a hangover the next day along with a migraine headache. I tried three = good for pain but horrible hangover and disorientation the next day and one half.

1.3

Patient Review

8/17/2022

Pregabalin for Nerve Pain from Spinal Cord Injury

I followed the instructions and took one pill, then two when that didn't work. The pain wasn't any better, but I felt awful the next day. Disoriented and with a splitting headache on top of the original pain. Three pills did help with the pain, but then I felt like I was losing my mind from the hangover. Overall, this was a terrible option for me.

1

Patient Review

7/19/2022

Pregabalin for Disorder characterized by Stiff, Tender & Painful Muscles

This pill is extremely dangerous. I was walking into walls and having all sorts of other problems when I took it. When it was offered to my elderly mother, I said no way. The weight gain from this pill is so bad that it should be banned worldwide. If a little child got this, I don't know if they would survive. It's an evil pill that causes terrible mental problems like depression and suicidal thoughts.

1

Patient Review

8/18/2022

Pregabalin for Acute Pain Following an Operation

I was given this medication after two failed spinal operations. I have been experiencing a lot of nerve pain, so they increased my dose to 225mg per day. I take one in the morning and two at night, but my pain is still here.

1

Patient Review

7/19/2022

Pregabalin for Disorder characterized by Stiff, Tender & Painful Muscles

This pill is dangerous. I was walking into walls and just everything. When it was offered to my elderly mum, there was no way. The weight gain from this pill is so bad. Lyrics should be banned worldwide. If a little child got this, I don't know if they would survive. Evil pill.. get rid of it for good.

1

Patient Review

8/18/2022

Pregabalin for Acute Pain Following an Operation

I was given this medication after two failed spinal surgeries. I have been dealing with a lot of nerve pain, and they increased my dose to 225mg per day. I take one pill in the morning and two at night, but I'm still in a lot of pain.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about pregabalin

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

Is pregabalin for mental health?

"Pregabalin is a drug that is related to the brain chemical GABA, which has a calming effect. Pregabalin reduces the release of brain chemicals that have a stimulating effect and can help with anxiety."

Answered by AI

What does pregabalin do to the nerves?

"Pregabalin is a medication used to treat seizures. It works by reducing the number of pain signals sent out by damaged nerves in the body."

Answered by AI

What is pregabalin used for?

"Pregabalin can help relieve certain types of nerve pain. It is typically used to treat conditions such as epilepsy, anxiety, and diabetic nerve pain. However, it can also be effective in treating nerve pain caused by other conditions such as shingles or an injury."

Answered by AI

Is pregabalin good for sleep?

"Treatment with pregabalin has been shown to improve all forms of insomnia and lead to reduced functional impairment and improved quality of life."

Answered by AI

Clinical Trials for Pregabalin

Image of Kessler Foundation in West Orange, United States.

Shockwave Therapy for Muscle Spasticity

18+
All Sexes
West Orange, NJ

Spasticity is a common consequence of spinal cord injury and can have a profound impact on quality of life. The goal of this study is to learn if an intervention called focused extracorporeal shockwave therapy can enhance the effectiveness of injections received for spasticity, such as Botox. The main questions this study seeks to answer are whether shockwave therapy and toxin injection 1) can improve spasticity symptoms greater than toxin injection alone, and 2) change the structure of the injected muscles. Researchers will compare the group who receives both shockwave therapy and toxin injection to a group who receives only toxin injection. Participants will be asked to visit the clinic five times over the span of three months. The first three visits will occur on three consecutive weeks, during which participants will receive shockwave therapy or the sham therapy. The final two visits will occur four and eight weeks later, during which participants will be asked a series of questions about their spasticity and have ultrasounds and MRIs collected of their leg muscles.

Phase 2
Recruiting

Kessler Foundation

Image of Vancouver General Hospital in Vancouver, Canada.

Dobutamine for Spinal Cord Injury

18 - 75
All Sexes
Vancouver, Canada

The first hours-to-day following acute traumatic cervical SCI represent a critical period of time to optimize hemodynamic management. After a spinal cord injury, cardiovascular function is affected. Maintaining blood pressure becomes is an important part of treatment as it supports recovery of the injured spinal cord. Blood pressure is most often increased using vasopressors, such as norepinephrine. Although these drugs help maintain blood flow, they may also lead to increased bleeding in the injury site, making the lesion worse. Alternatively, dobutamine, a medication that helps the heart pump more effectively, has shown to maintain blood pressure and improve prefusion at the injury site. This study will assess dobutamine capacity to maintain blood pressure acutely post injury.

Phase < 1
Waitlist Available

Vancouver General Hospital

Image of Hennepin Healthcare Research Institute in Minneapolis, United States.

Vibratory Genital Nerve Stimulation for Female Sexual Dysfunction

18 - 65
Female
Minneapolis, MN

The goal of this clinical trial is to learn if vibratory genital nerve stimulation (vGNS) can improve sexual function in women with spinal cord injury. The main question it aims to answer is: Does acute vGNS increase genital blood flow during a standardized sexual arousal assessment, as measured by laser speckle contrast imaging? Participants will: Complete a baseline in-clinic visit including two sexual arousal assessments with a vGNS session in between, while genital blood flow is measured using a non-invasive imaging device Use a vibration device at home twice weekly for 12 weeks Complete questionnaires about sexual function at baseline, during the home phase, and at a 12-week follow-up visit Attend a follow-up in-clinic visit repeating the baseline assessments

Recruiting
Has No Placebo

Hennepin Healthcare Research Institute

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We made a collection of clinical trials featuring Pregabalin, we think they might fit your search criteria.
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Image of Casa Colina Hospital and Centers for Healthcare in Pomona, United States.

Bowel Program Interventions for Spinal Cord Injury

18+
All Sexes
Pomona, CA

The goal of the study is to find out which of three different options (a suppository, a mini enema, or a transanal irrigation device) takes the least amount of time for completing bowel program amongst those who have spinal cord injuries with a neurogenic bowel. The main questions this study aims to answer are: * Does one of these tools meaningfully reduce the amount of time people with spinal cord injury need to complete their bowel programs? * Does one of these tools meaningfully reduce the number of times someone might experience incontinence or constipation? * Are participants satisfied in using these devices, and would they prefer to use the same tool at home? Researchers will compare the answers to these questions between the three different tools to improve quality of life for patients while improving the efficiency of the care provided. Participants in this study will: * Be enrolled in one of these options depending on when they are admitted to Casa Colina Hospital * Will receive the same tool for their bowel program for the majority or entirety of their stay * Will have a tracking sheet placed in their rooms for nursing to record when bowel program started and when it was completed * Will receive questionnaires when they enroll and when they finish the study on their experience with the tool and how likely they would be to use it at home

Recruiting
Has No Placebo

Casa Colina Hospital and Centers for Healthcare

Emily Rosario, PhD

Image of Methodist Rehabilitation in Jackson, United States.

Electrical Neuromodulation for Muscle Spasms

18+
All Sexes
Jackson, MS

Muscle stiffness and muscle spasms are common after spinal cord injury. They can interfere with washing and dressing, moving between the bed and a wheelchair, walking, and sleep, and they can cause pain. Oral medications are the usual first-line treatment, but many people report limited benefit or side effects. This study examines a non-surgical method called transcutaneous spinal stimulation. Surface electrodes are placed on the lower back and on the abdomen, and an electrical current is passed between them to activate nerve fibers entering the spinal cord. Adults who have had a spinal cord injury and have muscle stiffness or spasms in the legs may participate. Each participant takes part in all parts of the study and serves as their own comparison. Participants attend four visits at one study site, about one week apart. The first visit is for consent and a clinical examination. At each of the next three visits, the participant receives one capsule containing tizanidine, baclofen, or an inactive substance (placebo), in an order assigned by chance. One hour later, the participant receives two 15-minute periods of spinal stimulation, one at 30 pulses per second and one at 75 pulses per second, also in an order assigned by chance. Neither the participant nor the person conducting the testing knows which capsule was taken. Leg reflexes, muscle activity, and knee movement are measured before the capsule is taken, one hour after it is taken, during each period of stimulation, and after each period of stimulation. Clinical scales for stiffness and spasms are also scored. The study compares the two stimulation rates, compares stimulation with each medicine given alone, and examines whether adding stimulation to a medicine has a larger effect than stimulation alone.

Waitlist Available
Drug

Methodist Rehabilitation (+1 Sites)

Matthias J. Krenn, Ph.D.

Image of Rocky Mountain Regional VA Medical Center, Aurora, CO in Aurora, United States.

Testosterone Therapy for Spinal Cord Injury

18+
Male
Aurora, CO

Spinal cord injury (SCI) results in lower limb muscle loss, bone loss, and high fat mass that impede the recovery of physical function, increase bone fracture risk, and worsen health and quality of life. These deficits result from reduced activity after SCI and may be worsened by low testosterone, which is present in many men with SCI. In older men with low testosterone who do not have SCI, testosterone therapy (TRT) is known to increase muscle mass, muscle strength, and bone mineral density, and to reduce body fat. However, it is not known if TRT is effective in men with SCI. The purposes of this study are to determine the effectiveness of TRT in men who have low testosterone and difficulty walking after chronic motor incomplete SCI and to assess whether a process in the body that changes testosterone to dihydrotestosterone (DHT; another hormone that is stronger than testosterone) impacts the effectiveness of TRT in the impaired lower limbs and in other tissues after SCI. The researchers hypothesize that TRT will improve muscle and bone in the impaired limbs of men with chronic incomplete SCI and reduce fat mass, and that finasteride (a drug that blocks that blocks a process that changes testosterone to DHT) will influence prostate symptoms but not the musculoskeletal or body composition benefits produced by TRT.

Phase 2 & 3
Waitlist Available

Rocky Mountain Regional VA Medical Center, Aurora, CO (+3 Sites)

Joshua F Yarrow, PhD MS BS

Image of The University of Chicago in Chicago, United States.

Intrathecal CE-1 for Spinal Cord Injury

18+
All Sexes
Chicago, IL

The purpose of this study is to assess the safety and tolerability of intrathecal administration of CE-1 at a weight-based dose (cells/kg BW), capped at a maximum total dose of 1×10⁸ cells in 10 mL, with administered volume calculated using M = 0.167 mL/kg BW. Study details include: The overall study duration will be up to three years. The primary endpoint will be assessed at 6 months following investigational product administration. An additional secondary endpoint will be assessed at 12 months in the form of a phone call. Study visits therefore consist of one interventional visit, an evaluation visit within two weeks post-injection, a primary endpoint follow-up visit at 6 months, and a secondary endpoint follow-up phone call at 12-months.

Phase < 1
Waitlist Available

The University of Chicago

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We made a collection of clinical trials featuring Pregabalin, we think they might fit your search criteria.
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Image of Quality Living, Inc. in Omaha, United States.

Blood Flow-Restricted Exercise for Spinal Cord Injury

19 - 75
All Sexes
Omaha, NE

The goal of this clinical trial is to determine the effect of treatment frequency on the physical recovery of adults with incomplete spinal cord injury. The treatment will last for eight weeks and will occur either either two or three times weekly. The main research questions are: 1. How do changes in muscle strength compare between participants who receive eight weeks of blood flow-restricted exercise two times vs. three times weekly? 2. How do changes in the level of independence performing a selected functional task compare between participants who receive eight weeks of treatment two times vs. three times weekly? 3. How do changes in the perceived exertion needed to perform a functional task compare between participants who receive eight weeks of treatment two times vs. three times weekly? The researchers will compare people receiving treatment two vs. three times per week to see if they differ in the amount of change seen in muscle strength, level of independence performing a functional task requiring use of the targeted muscle group, and/or perceived exertion required to perform the functional task. Participants will: 1. complete three pre-treatment evaluation sessions to establish muscle strength, level of independence performing a functional task, and perceived exertion required to perform a functional task. 2. perform four sets of 20 muscle contraction repetitions of blood flow-restricted exercise on the left and right sides of the body using the targeted muscle group either two times or three times weekly depending on treatment group assignment. 3. complete three post-treatment evaluation sessions to establish muscle strength, level of independence performing a functional task, and perceived exertion required to perform a functional task.

Waitlist Available
Has No Placebo

Quality Living, Inc.

Karen Hux, Ph.D.

Image of UC Davis Point West in Sacramento, United States.

Rhythmic Auditory Stimulation for Spinal Cord Injury

18+
All Sexes
Sacramento, CA

This pilot study aims to evaluate the feasibility and preliminary efficacy of a wearable rhythmic auditory stimulation system, MedRhythms, for improving gait parameters in patients with motor incomplete SCI. Up to 15 participants aged 18 years or older with non-progressive SCI will be enrolled. Participants will complete supervised gait training using the MedRhythms device twice weekly during regularly scheduled physical therapy sessions over a six-week period. The device uses shoe-mounted sensors and headphones to deliver real-time individualized rhythmic auditory cues based on the user's gait pattern. Primary outcome measures include change in walking speed assessed with the 10-Meter Walk Test. Secondary outcomes include walking endurance measured by the 6-Minute Walk Test, gait parameters obtained through GAITRite analysis, and participant-reported outcomes including the Walking Index for Spinal Cord Injury II (WISCI II) and the SCI Quality of Life Satisfaction with Social Roles and Activities measure. Outcomes will be assessed at baseline, post-intervention (6 weeks), and follow-up (12 weeks). Findings from this study will provide preliminary data on the feasibility and potential clinical impact of rhythmic auditory stimulation as an adjunctive gait rehabilitation strategy for individuals with incomplete SCI.

Recruiting
Has No Placebo

UC Davis Point West

Shane Stone, MD

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