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NCT ID: NCT04509336 Terminated - Cirrhosis Clinical Trials

Orphenadrine Versus Baclofen in Treatment of Muscle Cramps in Cirrhotic Patients

Start date: August 20, 2020
Phase: N/A
Study type: Interventional

Muscle cramps are commonly affects patients with cirrhosis. It adversely influences the quality of life of cirrhotic patients. Treatment of muscle cramps still challenging owing to the diversity of the responsible pathophysiological mechanisms.The effectiveness of baclofen and orphenadrine in controlling muscle cramps in cirrhotic patients has been presented in recent randomised controlled clinical trials;however, the comparative efficacy and safety between these two therapeutic options has not been previously investigated.

NCT ID: NCT04507373 Terminated - Weakness, Muscle Clinical Trials

7T Magnetic Resonance Spectroscopy and Skeletal Muscle Biopsy Findings in Statin Associated Adverse Muscle Events

Start date: August 17, 2018
Phase: Phase 4
Study type: Interventional

Over 40 million Americans take statins to reduce their risk of atherosclerotic cardiovascular disease (ASCVD). Unfortunately, 10 to 20% stop taking them due to statin-associated muscle symptoms (e.g. pain, aches, weakness, cramps, or stiffness) (1, 2). The pathophysiology of these statin-associated muscle symptoms (SAMS) has remained elusive. Consequently, no objective diagnostic method exists, causing confusion for patient and providers since muscle symptoms can often be multifactorial.

NCT ID: NCT03976076 Terminated - Clinical trials for Refractory Infantile Spasms

A Study of Orally Administered JBPOS0101 in Refractory Infantile Spasms Patients

Start date: April 15, 2020
Phase: Phase 2
Study type: Interventional

A Phase 2 Study to Assess the Safety, Tolerability, Exploratory Efficacy, and pharmacokinetics of Orally Administered JBPOS0101 for Refractory Infantile Spasms Patients.

NCT ID: NCT03421496 Terminated - Infantile Spasm Clinical Trials

A Study to Assess Cannabidiol Oral Solution With Vigabatrin as Initial Therapy in Participants With Infantile Spasms

Start date: September 5, 2018
Phase: Phase 3
Study type: Interventional

The primary purpose of this study was to evaluate the efficacy, safety, and tolerability of Cannabidiol Oral Solution (CBD) as adjunctive therapy with vigabatrin as initial therapy, compared to vigabatrin alone in the treatment of infants newly diagnosed with Infantile Spasms (IS).

NCT ID: NCT03254199 Terminated - Clinical trials for Charcot-Marie-Tooth Disease

A Study to Assess the Safety and Effectiveness of FLX-787 in Subjects With Charcot-Marie-Tooth Disease Experiencing Muscle Cramps.

COMMIT
Start date: October 16, 2017
Phase: Phase 2
Study type: Interventional

The COMMIT Study will assess the safety and effectiveness of FLX-787 in men and women with Charcot-Marie-Tooth disease (CMT) experiencing muscle cramps. Participants will be asked to take two study products during the course of the study. One of these study products will be a placebo. Approximately 120 participants in 20 study centers across the United States are expected to take part. Participants will be in the study for approximately 3 months and visit the study clinic 3 times.

NCT ID: NCT03196375 Terminated - Clinical trials for Motor Neuron Disease

A Study to Assess FLX-787 in Subjects With Motor Neuron Disease Experiencing Muscle Cramps.

Start date: July 28, 2017
Phase: Phase 2
Study type: Interventional

The COMMEND Study will assess the safety and effectiveness of FLX-787 in men and women with Motor Neuron Disease [including Amyotrophic Lateral Sclerosis (ALS), Primary Lateral Sclerosis (PLS) or Progressive Muscular Atrophy (PMA)] experiencing muscle cramps. Participants will be asked to take two study products during the course of the study. One of these study products will be a placebo. Approximately 120 participants in approximately 30 study centers across the United States are expected to take part. Participants will be in the study for approximately 3 months and visit the study clinic 3 times.

NCT ID: NCT02829827 Terminated - Clinical trials for Infantile Spasms (IS)

A Phase 2 Study of Radiprodil in Subjects With Drug-resistant Infantile Spasms (IS)

Start date: December 4, 2017
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate the safety and tolerability, the pharmacokinetics and the efficacy of radiprodil in abolishing clinical spasms in subjects with drug-resistant infantile spasms

NCT ID: NCT02551731 Terminated - Spasms, Infantile Clinical Trials

Cannabidiol Oral Solution for Treatment of Refractory Infantile Spasms

Start date: January 27, 2016
Phase: Phase 2
Study type: Interventional

Infantile Spasms (IS) is a diagnosis described as a fairly rare and terrible form of epilepsy that usually strikes children in the first year of life. There is a great need for safe and effective therapies in the treatment of IS. This need is even more important for infants and toddlers still sick after being treated with medicine that is already available. This is a multi-center study to evaluate the efficacy and safety of Cannabidiol Oral Solution (CBD) in the treatment of children aged 6 months through 36 months with a diagnosis of infantile spasms who have not responded to first line therapies. The overall study duration is expected to be 64 weeks for those subjects who respond to CBD treatment. The maximum possible study duration for each patient is approximately 64 weeks, however a subject will be deemed to have completed the study after 58 weeks.

NCT ID: NCT01709968 Terminated - Quality of Life Clinical Trials

Magnesium Oxide Monohydrate for Nocturnal Leg Cramps

MgNLC
Start date: February 2013
Phase: Phase 4
Study type: Interventional

Nocturnal leg cramps (NLC) are painful, involuntary contractions of muscles occurring at rest, mostly at night. A Cochrane review on leg cramps in pregnancy showed some potential benefits in trials of magnesium. This is a single center, prospective, randomized, double blind, placebo controlled clinical trial that aims to investigate the effect of treatment with Magnox 520® (un-organic granular magnesium complex, composed of Magnesium Oxide & Magnesium Oxide Monohydrate 865mg, Provides 520 mg of free elemental Mg++) on frequency and severity of NLC, quality of sleep and quality of life. Hypothesis: Magnox 520® may reduce the number and severity of NLC; an improvement in the quality of life and quality of sleep may ensue.

NCT ID: NCT00715429 Terminated - Clinical trials for Leg Cramps, Nocturnal

Vitamin D for Painful Nocturnal Leg Cramps

Start date: August 2007
Phase: N/A
Study type: Interventional

1. Research question: Does vitamin D reduce the frequency and severity of nocturnal leg cramps in older persons who previously took quinine for leg cramps? 2. Experimental Design: This is a randomized, double blind, placebo controlled study of 70 men and women veterans receiving care at the Madison VA Medical Center(VAMC) or at the University of Wisconsin Hospitals and Clinics (UWHC). Individuals age 50 or more who have previously taken quinine for nocturnal leg cramps and meeting baseline criteria are eligible to enroll. Enrollees meeting laboratory criteria, including low-normal vitamin D levels, will undergo a 2-week "diary run-in" period to confirm cramp frequency. Those who report two or more leg cramps in each week will continue in the study and will be randomized to vitamin D or placebo. After a two-week wash-in, subjects will take a vitamin D capsule (50,000 units) once daily for 10 days, followed by a once weekly vitamin D (50,000 units) maintenance dose for 7 weeks. Subjects will record by diary the number and severity of leg cramps from the start of the "diary run-in" until a week after the last dose of study drug. Study investigators will call subjects at scheduled intervals to assess compliance, tolerability, and diary use. 3. Major risks to subjects: No major risks are anticipated. Excessive vitamin D can increase blood calcium levels (hypercalcemia), with symptoms such as thirst, nausea, and weakness. However, symptomatic hypercalcemia has not been reported except for those taking more than 40,000 units daily for several months. This is far above the cumulative dose in our study. 4. Potential benefits: Subjects may not receive any benefit. Vitamin D may alleviate leg cramps for subjects who receive it. 5. Consent Procedure: Flyers describing the study and telephone contact information will be mailed to patients who have received quinine during the period 2002-2007. The PI or Co-PI will return calls to describe the study and answer any questions. For persons meeting preliminary (pre-lab) study criteria, two copies of the consent form will be mailed, with the patient mailing back one signed consent to the PI.