Ryanodex

Malignant Hyperthermia, Muscle Spasticity, Malignant Hyperthermia + 4 more

Treatment

20 Active Studies for Ryanodex

What is Ryanodex

Dantrolene

The Generic name of this drug

Treatment Summary

Dantrolene is a medicine that does not work the same way as other drugs in its class, such as phenytoin. It is made from a chemical called a hydantoin derivative.

Dantrolene Sodium

is the brand name

Ryanodex Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Dantrolene Sodium

Dantrolene

2005

36

Effectiveness

How Ryanodex Affects Patients

Dantrolene is a medicine that helps relax the muscles. It is the only treatment for a dangerous condition called malignant hyperthermia. It works by interfering with the release of calcium from the muscles, which helps restore normal levels of calcium in the cells. In malignant hyperthermia, it is believed that certain drugs (like general anesthetics and muscle relaxants) cause an increase in calcium levels in the muscle cells, which can lead to a dangerous situation. Dantrolene helps bring the calcium levels back to normal.

How Ryanodex works in the body

Dantrolene works on muscle cells to prevent them from contracting. It does this by binding to a receptor in the muscle, which stops calcium from being released. Calcium is needed for muscles to contract, so without it, the muscle cannot move.

When to interrupt dosage

The optimal dose of Ryanodex is contingent upon the diagnosed condition, including Stroke, Spasticity and Spinal Cord Injury. The amount of dosage is reliant on the mode of delivery (e.g. Capsule - Oral or Injection, Solution - Intravenous) featured in the table underneath.

Condition

Dosage

Administration

Malignant Hyperthermia

, 25.0 mg, 50.0 mg, 100.0 mg, 2.0 mg/mL, 250.0 mg/mL, 20.0 mg

, Oral, Capsule, Capsule - Oral, Intravenous, Injection, Injection - Intravenous, Injection, suspension, Injection, suspension - Intravenous, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous, Powder, for solution, Powder, for solution - Intravenous, Injection, powder, for solution, Injection, powder, for solution - Intravenous, Injection, solution, Injection, solution - Intravenous

Malignant Hyperthermia

, 25.0 mg, 50.0 mg, 100.0 mg, 2.0 mg/mL, 250.0 mg/mL, 20.0 mg

, Oral, Capsule, Capsule - Oral, Intravenous, Injection, Injection - Intravenous, Injection, suspension, Injection, suspension - Intravenous, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous, Powder, for solution, Powder, for solution - Intravenous, Injection, powder, for solution, Injection, powder, for solution - Intravenous, Injection, solution, Injection, solution - Intravenous

Multiple Sclerosis

, 25.0 mg, 50.0 mg, 100.0 mg, 2.0 mg/mL, 250.0 mg/mL, 20.0 mg

, Oral, Capsule, Capsule - Oral, Intravenous, Injection, Injection - Intravenous, Injection, suspension, Injection, suspension - Intravenous, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous, Powder, for solution, Powder, for solution - Intravenous, Injection, powder, for solution, Injection, powder, for solution - Intravenous, Injection, solution, Injection, solution - Intravenous

Stroke

, 25.0 mg, 50.0 mg, 100.0 mg, 2.0 mg/mL, 250.0 mg/mL, 20.0 mg

, Oral, Capsule, Capsule - Oral, Intravenous, Injection, Injection - Intravenous, Injection, suspension, Injection, suspension - Intravenous, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous, Powder, for solution, Powder, for solution - Intravenous, Injection, powder, for solution, Injection, powder, for solution - Intravenous, Injection, solution, Injection, solution - Intravenous

Spinal Cord Injury

, 25.0 mg, 50.0 mg, 100.0 mg, 2.0 mg/mL, 250.0 mg/mL, 20.0 mg

, Oral, Capsule, Capsule - Oral, Intravenous, Injection, Injection - Intravenous, Injection, suspension, Injection, suspension - Intravenous, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous, Powder, for solution, Powder, for solution - Intravenous, Injection, powder, for solution, Injection, powder, for solution - Intravenous, Injection, solution, Injection, solution - Intravenous

Cerebral Palsy

, 25.0 mg, 50.0 mg, 100.0 mg, 2.0 mg/mL, 250.0 mg/mL, 20.0 mg

, Oral, Capsule, Capsule - Oral, Intravenous, Injection, Injection - Intravenous, Injection, suspension, Injection, suspension - Intravenous, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous, Powder, for solution, Powder, for solution - Intravenous, Injection, powder, for solution, Injection, powder, for solution - Intravenous, Injection, solution, Injection, solution - Intravenous

Muscle Spasticity

, 25.0 mg, 50.0 mg, 100.0 mg, 2.0 mg/mL, 250.0 mg/mL, 20.0 mg

, Oral, Capsule, Capsule - Oral, Intravenous, Injection, Injection - Intravenous, Injection, suspension, Injection, suspension - Intravenous, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous, Powder, for solution, Powder, for solution - Intravenous, Injection, powder, for solution, Injection, powder, for solution - Intravenous, Injection, solution, Injection, solution - Intravenous

Warnings

Ryanodex has six contraindications, so it should not be employed in combination with the conditions presented in the below table.

Ryanodex Contraindications

Condition

Risk Level

Notes

Muscle Spasticity

Do Not Combine

Muscle Spasticity

Do Not Combine

Cirrhosis

Do Not Combine

Hepatitis

Do Not Combine

Locomotion

Do Not Combine

Liver Diseases

Do Not Combine

There are 20 known major drug interactions with Ryanodex.

Common Ryanodex Drug Interactions

Drug Name

Risk Level

Description

Agmatine

Major

The risk or severity of hyperkalemia can be increased when Dantrolene is combined with Agmatine.

Amiodarone

Major

The risk or severity of hyperkalemia can be increased when Dantrolene is combined with Amiodarone.

Amlodipine

Major

The risk or severity of hyperkalemia can be increased when Dantrolene is combined with Amlodipine.

Aranidipine

Major

The risk or severity of hyperkalemia can be increased when Dantrolene is combined with Aranidipine.

Azelastine

Major

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

Ryanodex Toxicity & Overdose Risk

The toxic dose of this drug in rats is 7400mg/kg. Signs of an overdose include muscle weakness, confusion, vomiting, diarrhea, and the presence of crystals in the urine.

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

258 active clinical trials are examining the possible benefits of Ryanodex in treating Multiple Sclerosis, Spinal Cord Injury and Spasticity-related conditions.

Condition

Clinical Trials

Trial Phases

Muscle Spasticity

0 Actively Recruiting

Multiple Sclerosis

138 Actively Recruiting

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

Malignant Hyperthermia

0 Actively Recruiting

Malignant Hyperthermia

0 Actively Recruiting

Cerebral Palsy

1 Actively Recruiting

Not Applicable

Stroke

5 Actively Recruiting

Not Applicable, Phase 2, Phase 3

Spinal Cord Injury

82 Actively Recruiting

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

Patient Q&A Section about ryanodex

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

How do you administer RYANODEX?

"The recommended dosage of RYANODEX® for adults and children is 1 mg/kg, given as an intravenous push. If the person continues to have physiologic and metabolic abnormalities associated with MH, additional intravenous doses up to a maximum of 10 mg/kg may be given."

Answered by AI

Is RYANODEX the same as dantrolene?

"RYANODEX® uses a unique technology that helps it to address deficiencies that other dantrolene sodium products have."

Answered by AI

What is RYANODEX used for?

"The drug RYANODEX® is indicated for the treatment of a condition called malignant hyperthermia. This condition is treated by using appropriate supportive measures in addition to the drug. RYANODEX® is also indicated for the prevention of malignant hyperthermia in patients who are at a high risk for developing the condition."

Answered by AI

What do you mix RYANODEX with?

"What is the process for reconstituting RYANODEX®?

To reconstitute RYANODEX®, add 5 mL of sterile water for injection to the vial. Shake the vial until the RYANODEX® is mixed thoroughly (should take less than 10 seconds)."

Answered by AI

Clinical Trials for Ryanodex

Image of MS Barlo Centre, St Michael's Hospital in Toronto, Canada.

Online Cognitive Behavioural Therapy for Depression

18+
All Sexes
Toronto, Canada

Individuals with MS experience significantly high levels of depression which are higher than in any other chronic illness or neurological disorder. Depression can occur at any point in the course of the disease. Cognitive behavioural therapy (CBT) has been found to be effective in treating depression in people with MS. However, many individuals with MS who would benefit from CBT for depression do not participate in face-to-face treatment due to lack of clinician referral, accessibility, modality preference, cost, and mobility and travel issues due to health reasons. Given the acceptability and preference for telehealth treatment options, digital-based psychological interventions can be another appealing treatment option as these programs have the ability to deliver interactive CBT treatments for depression to individuals with MS at a time and location convenient to the individual. The current trial proposes to test the acceptability, effectiveness, satisfaction and cost-effectiveness of an 8-week online depression intervention targeting individuals with multiple sclerosis and compare this intervention with an 8-week online health and wellbeing in MS informational intervention.

Waitlist Available
Has No Placebo

MS Barlo Centre, St Michael's Hospital

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

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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.

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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

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

Physical Activity Intervention for Multiple Sclerosis

18+
All Sexes
Chicago, IL

The proposed study is a parallel-group randomized controlled trial (RCT) designed to establish the behavioral mechanism underlying a 16-week physical activity (PA) behavioral intervention through its effects on the Capability-Opportunity-Motivation-Behavior (COM-B) constructs. The success of this study will provide robust evidence for supporting its refinement via refined COM-B constructs and Behavior Change Techniques to facilitate or maximize the intervention effects on PA levels, which will be examined in the subsequent clinical trial. Such an approach will involve an RCT that examines the effects of a 16-week remotely delivered, Internet-based PA behavioral intervention via video behavioral coaching and newsletter compared with a waitlist control (WLC) condition for yielding improvements in the COM-B constructs among persons newly diagnosed with multiple sclerosis (PNDwMS, disease duration ≤ 2 years). The investigators hypothesize that participants in the PA behavioral intervention condition will demonstrate greater improvements in the COM-B constructs than those in the WLC condition. The investigators plan to recruit 50 PNDwMS, with a distribution of 25 participants in the PA behavioral intervention and 25 participants in the WLC condition. The primary outcomes are the self-report COM-B constructs (listed in the Outcomes section), which will be remotely assessed at baseline and post-intervention through an online battery of questionnaires via REDCap. Specific Aim 1: to establish mechanisms for the behavior change intervention using a 2-arm pilot randomized controlled trial (RCT) of the intervention compared with the waitlist control (WLC) among PNDwMS. The investigators hypothesize that the 16-week COM-B-based behavioral intervention delivered by one-on-one behavior coaching and newsletters will result in larger changes in COM-B constructs (i.e., knowledge, outcome expectations, goal, intention, behavioral regulation, self-efficacy, fatigue, social support, and social and environmental barriers) than in the WLC group. Specific Aim 2: to examine change in self-reported physical activity levels in PNDwMS who received the COM-B-based intervention compared with those who are in the waitlist control condition. The investigators hypothesize that the 16-week COM-B-based behavioral intervention will result in larger changes in self-reported physical activity outcomes than in the WLC group.

Waitlist Available
Has No Placebo

University of Illinois Chicago

Robert Motl, PhD

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