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Spasm clinical trials

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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: NCT04474977 Not yet recruiting - Hemifacial Spasm Clinical Trials

Microvascular Decompressive Surgery for Hemifacial Spasm

Start date: September 1, 2020
Phase:
Study type: Observational

- Review the clinical outcomes of Micro vascular decompression of Hemi facial Spasm. - Assess safety and efficacy of Micro vascular decompression. - Improve the outcome of these patients and decease rate of recurrence and complications.

NCT ID: NCT04302116 Recruiting - Infantile Spasm Clinical Trials

Vigabatrin With High Dose Prednisolone Combination Therapy vs Vigabatrin Alone for Infantile Spasm

Start date: May 18, 2020
Phase: N/A
Study type: Interventional

Infantile spasms (IS) are seizures associated with a severe infantile epileptic encephalopathy. Both cessation of spasms and electrographic response are necessary for the best neurodevelopmental outcomes. Adrenocorticotrophic hormone (ACTH), or prednisolone, or vigabatrin are considered the first-line treatment individually. However, ACTH expense and availability are the barriers in developing countries including Thailand. Vigabatrin, therefore, is the first recommended by Epilepsy Society of Thailand due to ACTH unavailability. Recently, combined steroid treatments (either ACTH or high dose prednisolone) with vigabatrin are superior in cessation of spasms compared to steroid treatment alone. Thus, this study is aimed to compare the efficacy of vigabatrin with high dose prednisolone combination therapy and vigabatrin alone.

NCT ID: NCT04289467 Recruiting - Infantile Spasm Clinical Trials

Treatment of Refractory Infantile Spasms With Fenfluramine

Start date: June 16, 2023
Phase: Phase 2
Study type: Interventional

This is a phase II clinical trial in which children with refractory infantile spasms (also called epileptic spasms or West syndrome) will be treated with fenfluramine, to evaluate efficacy, safety, and tolerability. Patients with infantile spasms that have not responded to treatment with vigabatrin and ACTH we will be invited to participate. Study participants will undergo baseline video-EEG, receive treatment with fenfluramine for 21 days, and then undergo repeat video-EEG to determine effectiveness. Patients with favorable response will have the opportunity to continue treatment for up to 6 months.

NCT ID: NCT04086992 Recruiting - Clinical trials for Infantile Spasms, Non-Intractable

Decreasing Parental Stress of Caregivers of Infants With Infantile Spasms by Using Telemedicine Technology

Start date: October 10, 2019
Phase: N/A
Study type: Interventional

This study plans to learn more about how the use of new telemedicine technology can help with parental stress, costs, and overall satisfaction in care. Investigators are studying this in families who have children with a specific seizure type called infantile spasms and being treated with a medication called ACTH (adrenocorticotropic hormone). Infantile spasms is a rare epileptic encephalopathy that occurs within the first two years of life. It is associated with complicated and expensive treatment and poor developmental outcomes. Participants will be randomly placed in one of two groups. The first group will continue with the traditional monitoring practices primarily performed by their pediatrician. The second group will use telemedicine technology to be monitored. Investigators will then compare the two groups to see if there are any differences in parental stress, costs of care, and/or overall satisfaction with care. The primary hypothesis is that compared to those utilizing usual monitoring, parents/caregivers of infants with IS treated with ACTH utilizing nurse-led remote biometric monitoring will report less parenting stress at 2 and 4 weeks of treatment.

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: NCT03876444 Recruiting - Infantile Spasm Clinical Trials

Intravenous Methylprednisolone Versus Oral Prednisolone for Infantile Spasms

MPIV
Start date: April 1, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

Infantile Spasms (IS) are classically refractory to the usual antiepileptic drugs and often pose a therapeutic challenge. Since, there is associated significant morbidity, much effort has been directed over the past years to evaluate the role of various anticonvulsants in the management of IS. High dose oral prednisolone has been shown to cause early cessation of spasms and resolution of hypsarrythmia on Electroencephalogram. Recently, role of intravenous methylprednislone pulse therapy has been explored as one of the therapeutic modality in IS, in order to avoid the development of side-effects associated with prolonged oral steroid therapy and maintain long-term efficacy.However, there are no studies comparing iv methylprednisolone pulse therapy with high dose oral prednisolone..

NCT ID: NCT03864770 Recruiting - Clinical trials for Nocturnal Leg Cramps

Extracorporeal Shock Wave Therapy Treatment for Nocturnal Leg Cramps

Start date: March 5, 2019
Phase: N/A
Study type: Interventional

Nocturnal leg cramps (NLCs) are often described as a symptom of sudden and involuntary muscle contraction at night, which often affects sleep quality due to pain and tight discomfort in the thigh, calf and foot. The investigator performed extracorporeal shock wave therapy (ESWT). This experiment used a randomized experiment to assess the immediate, short-term and long-term effects of extracorporeal shock wave therapy on patients with nocturnal leg cramps.

NCT ID: NCT03807141 Recruiting - Epileptic Spasms Clinical Trials

Evaluation of the Modified Atkins Diet in Children With Epileptic Spasms

Start date: January 15, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

Epileptic spasms are a difficult to treat epileptic condition in young children. The first line treatment is hormonal treatment, in the form of ACTH or oral steroids, which are effective in 60-70% of children. The condition does not respond well to other anti-epileptic drugs except vigabatrin which is not approved and hence has limited availability and high cost in India. The ketogenic diet, a high fat low carbohydrate diet has been found to be effective in refractory childhood epilepsy especially epileptic spasms. However, the ketogenic diet restricts calories and proteins and required strict weighing of foods. The modified Atkins diet (MAD) is a less restrictive diet which is easier for the parents to prepare and for the children to consume. In this study, it is planned to evaluate the efficacy of the MAD in children with epileptic spasms refractory to hormonal treatment in a randomized controlled trial.

NCT ID: NCT03802565 Completed - Low Back Pain Clinical Trials

Tolperisone in Acute Muscle Spasm of the Back

STAR
Start date: February 1, 2019
Phase: Phase 2
Study type: Interventional

This is a double-blind, randomized, placebo-controlled, parallel group study of the efficacy and safety of tolperisone (a non-opioid) or placebo administered as multiple doses three times a day (TID) in approximately 400 male and female subjects experiencing back pain due to or associated with muscle spasm.