Clinical trials: Neuromuscular Disorder
Polymyositis, Dermatomyositis
Open-label Extension to the Phase 2 Crossover Study (PRESIDIO) Evaluating KZR-616 in Patients With PM and DM.
This was an open-label study to evaluate the long-term efficacy and safety of KZR-616 in patients with active polymyositis (PM) or dermatomyositis (DM) who completed the double-blind treatment period of Study KZR-616-003, up to…
- Trial name
- NCT04628936
- Testing
- KZR-616
- Where
- 10 sites in United States, Czechia
- Volunteers
- 18 people
- Sponsor
- Kezar Life Sciences, Inc.
Muscular Atrophy, Spinal
A Study Evaluating the Effectiveness and Safety of Risdiplam Administered in Pediatric Patients With Spinal Muscular Atrophy Who Experienced a Plateau or Decline in Function After Gene Therapy
This is an open-label, single-arm, multicenter clinical study to evaluate the effectiveness and safety of risdiplam administered in pediatric participants with SMA and 2 SMN2 copies who previously received onasemnogene…
- Trial name
- HINALEA 2 (NCT05861999)
- Testing
- Risdiplam
- Where
- 17 sites in United States, Germany and 4 more
- Volunteers
- 19 people
- Sponsor
- Hoffmann-La Roche
Duchenne Muscular Dystrophy
Long-term, Extension Study of DS-5141b in Patients With Duchenne Muscular Dystrophy
This is a multicenter, open-label, long-term, extension, phase 2 study to evaluate the safety and efficacy of long-term treatment with DS-5141b in patients with DMD who have completed DS5141-A-J101.
- Trial name
- NCT04433234
- Testing
- DS-5141b
- Where
- 2 sites in Japan
- Volunteers
- 8 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
Amyotrophic Lateral Sclerosis
A Study of GDC-0134 to Determine Initial Safety, Tolerability, and Pharmacokinetic Parameters in Participants With Amyotrophic Lateral Sclerosis
This first-in-human, double-blind, placebo-controlled Phase I study will be conducted in participants with amyotrophic lateral sclerosis (ALS) to explore safety, tolerability, and pharmacokinetic (PK) properties of GDC-0134.
- Trial name
- NCT02655614
- Testing
- GDC-0134, Rabeprazole, Midazolam
- Where
- 10 sites in United States, Canada and 1 more
- Volunteers
- 54 people
- Sponsor
- Genentech, Inc.
Non Small Cell Lung Cancer (NSCLC), Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Study of PX-866 and Docetaxel in Solid Tumors
Phase 1: To determine the maximally tolerated dose (MTD) or recommended dose (RD) and any potential efficacy of PX-866 in combination with docetaxel in patients with solid tumors.
- Trial name
- NCT01204099
- Testing
- Docetaxel, PX-866
- Where
- 33 sites in United States, Canada
- Volunteers
- 223 people
- Sponsor
- Cascadian Therapeutics Inc.
Fibromyalgia
A Study to Test the Effectiveness and Safety of Fremanezumab on Participants With Fibromyalgia
The primary objective of the study is to estimate the treatment effect of fremanezumab administered subcutaneously (SC) in reducing pain in adult participants with fibromyalgia (FM).
- Trial name
- NCT03965091
- Testing
- Fremanezumab
- Where
- 49 sites in United States
- Volunteers
- 189 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Carpal Tunnel Syndrome, CTS
Trial of Ultrasound Guided Carpal Tunnel Release Versus Traditional Open Release (TUTOR)
Study to compare the safety and effectiveness of carpal tunnel release with ultrasound guidance (CTR-US) vs. mini-open carpal tunnel release (mOCTR) in patients with symptomatic carpal tunnel syndrome (CTS).
- Conditions
- Carpal Tunnel Syndrome, CTS, Carpal Tunnel
- Trial name
- TUTOR (NCT05405218)
- Testing
- CTR with Ultrasound Guidance using the UltraGuideCTR device, mOCTR
- Where
- 12 sites in United States
- Volunteers
- 122 people
- Sponsor
- Sonex Health, Inc.
Amyotrophic Lateral Sclerosis
Safety/Efficacy of AVP-923 in the Treatment of Emotional Lability (Uncontrolled Crying & Laughing) in Patients With ALS
The purpose of this study is to compare and evaluate the safety of AVP-923 (dextromethorphan/quinidine) for the treatment of emotional lability in ALS patients.
- Trial name
- NCT00021697
- Testing
- AVP-923
- Where
- 17 sites in United States
- Volunteers
- 100 people
- Sponsor
- Avanir Pharmaceuticals
Pain, Delayed Onset Muscle Soreness
Phase II Study of AP0302 5% Versus a Vehicle Comparator
This study is designed to evaluate the analgesic safety and efficacy of study drug (AP0302) applied topically every 6 hours as compared to a vehicle, in subjects experiencing delayed onset muscle soreness.
- Trial name
- NCT02324985
- Testing
- S-Ibuprofen Topical Gel 5%, Vehicle Topical Gel
- Where
- United States
- Volunteers
- 147 people, healthy volunteers welcome
- Sponsor
- Aponia Laboratories, Inc.
Generalized Myasthenia Gravis
Efficacy and Safety Study of GB-0998 for Treatment of Generalized Myasthenia Gravis
This randomized controlled, multi-center study will carry out to assess the efficacy of GB-0998 compared to plasmapheresis in the treatment of the generalized Myasthenia Gravis based on the changes in Quantitative Myasthenia…
- Trial name
- NCT00515450
- Testing
- GB-0998 (Intravenous immunoglobulin), Plasmapheresis
- Where
- Japan
- Volunteers
- 46 people
- Sponsor
- Benesis Corporation
Myasthenia Gravis
Efficacy and Safety of IGIV-C in Corticosteroid Dependent Patients With Generalized Myasthenia Gravis
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) as a corticosteroid (CS)-sparing agent in…
- Trial name
- NCT02473965
- Testing
- IGIV-C
- Where
- 39 sites in United States, Belgium and 8 more
- Volunteers
- 60 people
- Sponsor
- Grifols Therapeutics LLC
Centronuclear Myopathy
Natural History Study of Patients With Centronuclear Myopathies
This is a prospective, longitudinal study of the natural disease course intended to recruit approximately 60 patients with centronuclear myopathies (CNM) in Europe and the United States.
- Trial name
- NatHis-CNM (NCT04977648)
- Sponsor
- Dynacure
Diabetic Neuropathy
A Study to Compare Safety and Efficacy of Tramadol Hydrochloride/Acetaminophen With Gabapentin in Participants With Diabetic Neuropathy
The purpose of this study is to evaluate the effectiveness and safety of tramadol hydrochloride (HCl) 37.5 miligram (mg)/acetaminophen 325 mg compared to gabapentin in participants with diabetic neuropathic (nerve disorder caused…
- Trial name
- NCT00634543
- Testing
- Tramadol hydrochloride/ Acetaminophen, Gabapentin
- Volunteers
- 162 people
- Sponsor
- Janssen Korea, Ltd., Korea
Botulism
Phase 3, Randomized, Safety, Lot Consistency and Clinical Benefit Study of Recombinant Botulinum Vaccine A/B
This Phase 3 clinical trial is a double blind, placebo-controlled, randomized, multicenter investigation of rBV A/B in male and female healthy adults 18 to 55 years of age.
- Trial name
- rBV A/B (NCT01940315)
- Testing
- rBV A/B
- Volunteers
- healthy volunteers welcome
- Sponsor
- DynPort Vaccine Company LLC, A GDIT Company
Atrophy, Muscular
A Clinical Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral SRT2104 Capsules Administered to Healthy Elderly Subjects for 28 Days
The primary objective is to determine the pharmacokinetics, safety and tolerability of SRT2104 in healthy elderly subjects following single and 28 days dosing. The secondary objectives of the study are: 1.
- Trial name
- NCT00964340
- Testing
- SRT2104
- Where
- United Kingdom
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Post-Stroke Spasticity, Cerebrovascular Accident
Study of GSK1358820 In Patients With Post-Stroke Lower Limb Spasticity
This is a study to confirm the superior efficacy of GSK1358820 over placebo in patients with equinus deformity associated with post-stroke lower limb spasticity using the Modified Ashworth Scale (MAS) ankle score.
- Trial name
- NCT00460655
- Testing
- GSK1358820
- Where
- 20 sites in Japan
- Volunteers
- 120 people
- Sponsor
- GlaxoSmithKline
Fibromyalgia
Efficacy and Safety of NYX-2925 in Subjects With Fibromyalgia
To evaluate the efficacy of NYX-2925 versus placebo for the treatment of fibromyalgia.
- Trial name
- NCT04147858
- Testing
- NYX-2925
- Where
- 42 sites in United States
- Volunteers
- 310 people
- Sponsor
- Aptinyx
Neurofibromatosis Type 1
Phase I Study to Assess the Effect of Food on the PK and Gastrointestinal Tolerability of Selumetinib in Adolescent Children With Neurofibromatosis Type 1 Related Plexiform Neurofibromas
This study in adolescent participants with NF1 who have inoperable PN is designed to evaluate the effect of a low fat meal on steady state selumetinib exposure; to assess the effect on GI tolerability when selumetinib is dosed…
- Trial name
- NCT05101148
- Testing
- Selumetinib
- Where
- 9 sites in United States, Poland and 2 more
- Volunteers
- 24 people
- Sponsor
- AstraZeneca
Chronic Fatigue Syndrome (CFS), Myalgic Encephalomyelitis (ME)
The Synergy Trial: Methylphenidate Plus a CFS-Specific Nutrient Formula as a Treatment for Chronic Fatigue Syndrome
The Synergy Trial will evaluate the safety and efficacy of a currently available medication (methylphenidate hydrochloride) combined with a CFS-specific dietary supplement (CFS Nutrient Formula) to treat Chronic Fatigue Syndrome…
- Trial name
- NCT01966276
- Testing
- Methyl-P plus Nutrient Formula
- Where
- 4 sites in United States
- Volunteers
- 134 people
- Sponsor
- K-PAX Pharmaceuticals, Inc.
Muscular Dystrophy, Duchenne
An Open-Label Extension Study for Patients With Duchenne Muscular Dystrophy Who Participated in Studies of SRP-5051 (Vesleteplirsen)
The purpose of this extension study is to evaluate the safety, tolerability, and pharmacokinetics of repeat administrations of SRP-5051 (vesleteplirsen) in participants with Duchenne muscular dystrophy (DMD) who participated in…
- Trial name
- NCT03675126
- Testing
- SRP-5051
- Where
- 8 sites in United States, Canada
- Volunteers
- 15 people
- Sponsor
- Sarepta Therapeutics, Inc.
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