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Muscular Diseases clinical trials

View clinical trials related to Muscular Diseases.

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NCT ID: NCT05456997 Terminated - Pheochromocytoma Clinical Trials

Metabolic Myopathy in Endocrinopathy

LYDIA
Start date: March 20, 2023
Phase:
Study type: Observational

Endocrine diseases including Cushing's syndrome and phaeochromocytoma/paraganglioma (PPGL) but not Conn's syndrome are associated with muscle wasting and weakness. The study's aim is to identify epigenetic determinants of muscle homeostasis in these conditions following medical treatment and adrenalectomy. This is an observational pilot study that will recruit 66 patients from 3 diagnostic groups: Cushing's syndrome (16), PPGL (20) and Conn's syndrome (30). Indices of muscle bulk and strength will be assessed at diagnosis and at outpatient follow-up 6-9 weeks after adrenalectomy. At these times blood and urine will be collected and a muscle biopsy taken from the operation site at the time of surgery. Pathway analysis in these samples will identify potentially novel signalling pathways contributing to muscle wasting via prolonged exposure to high levels of corticosteroid and catecholamines. This will highlight commonalities and differences in pathogenesis of muscle wasting from a variety of different causes. Finally, it will inform identification of novel therapies for muscle atrophy.

NCT ID: NCT05267574 Terminated - Clinical trials for Primary Mitochondrial Myopathy

An Open Label, Long Term Safety Study of REN001 in Primary Mitochondrial Myopathy Patients (Stride Ahead)

Start date: February 1, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

This study is designed to evaluate the long-term safety and tolerability of REN001 administered once daily to subjects with PMM due to mitochondrial DNA mutations (mtDNA-PMM) or nuclear DNA mutations (nDNA-PMM). Subjects with mtDNA mutations will have previously completed Study REN001-201 or participated in Study REN001-101. Subjects with nDNA mutations who enroll in this study will be REN001- naïve.

NCT ID: NCT04641962 Terminated - Clinical trials for Primary Mitochondrial Myopathy

A Study to Evaluate ASP0367 in Participants With Primary Mitochondrial Myopathy

MOUNTAINSIDE
Start date: May 17, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the dose response of ASP0367 on functional improvement relative to placebo, safety, and tolerability in participants with Primary Mitochondrial Myopathy.

NCT ID: NCT04033159 Terminated - Clinical trials for Centronuclear Myopathy

Early Phase Human Drug Trial to Investigate Dynamin 101 (DYN101) in Patients ≥ 16 Years With Centronuclear Myopathies

Unite-CNM
Start date: January 9, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

There are no available treatments aside from supportive care for patients with Centronuclear myopathy (CNM). This trial will assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD)/preliminary efficacy of a new medicine called DYN101 in patients ≥ 16 years of age with CNM caused by mutations in Dynamin2 (DNM2) or Myotubularin1 (MTM1). The trial will consist of a consent, a screening period, a run-in period (if applicable), a Single dose treatment part (SAD) with 4 weeks of follow-up after the drug administration and a washout period of at least 12 weeks (followed by follow-up phone calls), a Multiple dose treatment part (MAD) of 12 weeks of weekly dosing, and a Multiple dose extension part of 12 weeks. All subjects will participate in the SAD, MAD, and MAD extension parts, unless they withdraw. During this time, multiple test will be performed in order to better understand how the drug is distributed and then later removed from the body and whether there any signs of an effect. As this trial is investigational, there is no defined, expected benefit for subjects who participate in this trial except a better knowledge of their disease.

NCT ID: NCT04025632 Terminated - Clinical trials for Immune Mediated Necrotizing Myopathy

Safety and Efficacy Study of Zilucoplan in Subjects With Immune-Mediated Necrotizing Myopathy

Start date: November 7, 2019
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate the safety and efficacy of zilucoplan in patients with Immune-Mediated Necrotizing Myopathy (IMNM). Subjects will be randomized in a 1:1 ratio to receive daily SC doses of 0.3 mg/kg zilucoplan or matching placebo for 8 weeks.

NCT ID: NCT03862846 Terminated - Clinical trials for Primary Mitochondrial Myopathy

A Study of the Safety of REN001 in Patients With Primary Mitochondrial Myopathy

Start date: May 10, 2019
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess REN001 safety in subjects with primary mitochondrial myopathy

NCT ID: NCT03323749 Terminated - Clinical trials for Primary Mitochondrial Myopathy

A Trial to Evaluate Safety and Efficacy of Elamipretide Primary Mitochondrial Myopathy Followed by Open-Label Extension

MMPOWER-3
Start date: October 9, 2017
Phase: Phase 3
Study type: Interventional

This is a multicenter phase 3 randomized, double-blind, parallel-group, placebo-controlled trial to evaluate the safety and efficacy of daily subcutaneous injections of elamipretide in subjects with primary mitochondrial myopathy. This will be followed by an open-label treatment extension.

NCT ID: NCT02830763 Terminated - Clinical trials for Primary Triglyceride Deposit Cardiomyovasculopathy (TGCV)

Clinical Study on the Safety of CNT-02 for TGCV and NLSD-M

Start date: September 5, 2016
Phase: N/A
Study type: Interventional

This study is planning to evaluate the safety and clinical efficacy of medium-chain fatty acid capsules (food-grade CNT-02) in subjects with primary triglyceride deposit cardiomyovasculopathy (TGCV) and neutral lipid storage disease with myopathy (NLSD-M) associated with adipose triglyceride lipase (ATGL) genetic defects.

NCT ID: NCT02829814 Terminated - Fibromyalgia Clinical Trials

Repeat of: A Study to Evaluate Efficacy and Safety of Sublingual TNX-102 SL Tablet Taken at Bedtime in Patients With Fibromyalgia

RE-AFFIRM
Start date: July 2016
Phase: Phase 3
Study type: Interventional

The present trial is designed to assess the safety and efficacy of TNX-102 SL 2.8 mg tablets, taken daily at bedtime after 12 weeks of treatment in patients with fibromyalgia. The use of low-dose sublingual formulation of cyclobenzaprine (TNX-102 SL) dosed nightly for fibromyalgia is supported by the results of TNX-CY-F202 Phase 2b study -- the results provide strong evidence that TNX-102 SL 2.8 mg dosed nightly results in beneficial effects upon pain, sleep and other FM symptomatology.

NCT ID: NCT02736188 Terminated - GNE Myopathy Clinical Trials

Study to Evaluate the Safety and Efficacy of Aceneuramic Acid Extended-Release (Ace-ER) Tablets in Patients With Glucosamine (UDP-N-acetyl)-2-epimerase Myopathy (GNEM) or Hereditary Inclusion Body Myopathy (HIBM)

Start date: May 2, 2016
Phase: Phase 3
Study type: Interventional

The objective of this study is to evaluate the long-term safety and efficacy of Ace-ER treatment in subjects with GNEM.