Clinical trials: Muscle Disorders
Becker Muscular Dystrophy
Safety and Biomarker Response to (+)-Epicatechin in Becker Muscular Dystrophy
This is a Phase 1, open-label, dose escalation study aimed at evaluating the safety, early efficacy and potential biomarkers of (+)-epicatechin in patients with Becker or Becker-like Muscular Dystrophy (BMD).
- Trial name
- NCT04386304
- Testing
- (+)-Epicatechin
- Where
- 3 sites in United States
- Volunteers
- 22 people
- Sponsor
- Epirium Bio Inc.
Muscular Atrophy, Spinal
A Study of Risdiplam in Infants With Genetically Diagnosed and Presymptomatic Spinal Muscular Atrophy
A global study of oral risdiplam in pre-symptomatic participants with spinal muscular atrophy (SMA).
- Trial name
- Rainbowfish (NCT03779334)
- Testing
- Risdiplam
- Where
- 7 sites in United States, Australia and 5 more
- Volunteers
- 26 people
- Sponsor
- Hoffmann-La Roche
Duchenne Muscular Dystrophy
Phase I/II Study of SRP-4053 in DMD Patients
This is a first-in-human, multiple-dose 2-part study to assess the safety, tolerability, efficacy, and pharmacokinetics of SRP-4053 in Duchenne muscular dystrophy (DMD) patients with deletions amenable to exon 53 skipping.
- Trial name
- NCT02310906
- Testing
- SRP-4053
- Where
- 5 sites in United States, France and 2 more
- Volunteers
- 39 people
- Sponsor
- Sarepta Therapeutics, Inc.
Fibromyalgia
Prospective Evaluation of RINCE to Reduce Fibromyalgia Effects - 202
The purpose of this study is to test the safety and efficacy of a noninvasive cortical electrostimulation therapy known as "Reduced Impedance Noninvasive Cortical Electrostimulation" (RINCE) in the treatment of pain associated…
- Trial name
- PERRFECT-202 (NCT02613949)
- Testing
- RINCE
- Where
- 4 sites in United States
- Volunteers
- 45 people
- Sponsor
- Cerephex Corporation
Chronic Wound, Myofascial Pain Syndrome
Extended Therapeutic Effect of 35kDa Hyaluronan Fragment Injection in Patients With Chronic Pain Caused by Myofascial Pain Syndrome
To verify the efficacy and safety of HA35 in chronic pain management and to further supplement effective treatments for chronic pain, we designed a proof-of-concept clinical study.
- Trial name
- NCT06444035
- Testing
- HA35 injection
- Where
- Mongolia
- Volunteers
- 10 people
- Sponsor
- Nakhia Impex LLC
Peripheral Arterial Occlusive Disease
Gene Expression and Tolerability Study of NV1FGF in Patients With Peripheral Artery Occlusive Disease Planned to Undergo Major Amputation
The primary objective is to evaluate the transgene expression (synthesis of FGF-1 mRNA) in injected tissue, at injection site, after Intra Muscular (IM) administration of increasing single doses of NV1FGF.
- Trial name
- NCT01157143
- Testing
- XRP0038 (NV1FGF)
- Where
- 2 sites in United States, Switzerland
- Volunteers
- 6 people
- Sponsor
- Sanofi
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
Musculoskeletal Pain
A Phase 1 Clinical Trial DHP2306R1 and DHP2306R2 in Healthy Adult Volunteers
This phase 1 study is to evaluate the safety and pharmacokinetic drug interactions of DHP2306R1 and DHP2306R2 when administered alone and in combination in healthy conditions.
- Trial name
- NCT06395155
- Testing
- DHP2306R1, DHP2306R2
- Where
- South Korea
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Daehwa Pharmaceutical Co., Ltd.
Ependymoma, Ewing Sarcoma
A Study of Bempegaldesleukin (BEMPEG: NKTR-214) in Combination With Nivolumab in Children, Adolescents and Young Adults With Recurrent or Treatment-resistant Cancer
The purpose of this study is to first, in Part A, assess the safety, tolerability and drug levels of Bempegaldesleukin (BEMPEG) in combination with nivolumab and then, in Part B, to estimate the preliminary efficacy in children…
- Conditions
- Ependymoma, Ewing Sarcoma, High-grade Glioma, Leukemia and Lymphoma
- Trial name
- PIVOT IO 020 (NCT04730349)
- Testing
- Nivolumab, NKTR-214
- Where
- 18 sites in United States, Australia and 4 more
- Volunteers
- 15 people
- Sponsor
- Bristol-Myers Squibb
Duchenne Muscular Dystrophy
Study to Assess the Efficacy and Safety of Viltolarsen in Ambulant Boys With DMD (RACER53)
The main objective of this study is to evaluate the efficacy of Viltolarsen compared to placebo in Duchenne muscular dystrophy (DMD) patients amenable to exon 53 skipping.
- Trial name
- NCT04060199
- Testing
- Viltolarsen
- Where
- 40 sites in United States, Australia and 17 more
- Volunteers
- 77 people
- Sponsor
- NS Pharma, Inc.
Fibroid Uterus, Leiomyoma
Study of Asoprisnil in the Treatment of Uterine Fibroids.
The objective of this study is to determine the long-term safety of asoprisnil in women with abnormal uterine bleeding associated with uterine fibroids.
- Conditions
- Fibroid Uterus, Leiomyoma, Menorrhagia, Metrorrhagia
- Trial name
- NCT00156156
- Testing
- Asoprisnil
- Volunteers
- 149 people
- Sponsor
- Abbott
Dermatomyositis
Trial of IMO-8400 in Adult Patients With Dermatomyositis
The purpose of this study is to determine how safe and effective IMO-8400 is in adults with dermatomyositis.
- Trial name
- 8400-211 (NCT02612857)
- Testing
- IMO-8400 Dose Group 1, IMO-8400 Dose Group 2
- Where
- 20 sites in United States, Hungary and 1 more
- Volunteers
- 30 people
- Sponsor
- Idera Pharmaceuticals, Inc.
Increased Lordosis/Scoliosis, Hyporeflexia
Biomarker for Duchenne Muscular Dystrophy
International, multicenter, observational, longitudinal study to identify biomarker/s for Duchenne Muscular Dystropy (DMD) and to explore the clinical robustness, specificity, and long-term variability of these biomarker/s.
- Conditions
- Increased Lordosis/Scoliosis, Hyporeflexia, Duchenne Muscular Dystrophy, Red-Green Color Blindness
- Trial name
- BioDuchenne (NCT02994030)
- Where
- 12 sites in Albania, Egypt and 6 more
- Volunteers
- 103 people
- Sponsor
- CENTOGENE GmbH Rostock
Fibromyalgia
A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin In Patients With Fibromyalgia
This study will assess the safety and efficacy of the long-term use of pregabalin at doses up to 450 mg/day in patients with fibromyalgia who have completed 16 weeks of dosing in Study A0081208 (NCT00830167).
- Trial name
- NCT00830128
- Testing
- pregabalin (Lyrica)
- Where
- 19 sites in Japan
- Volunteers
- 106 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Multiple Sclerosis
IPX056 in Subjects With Established Spasticity Resulting From Multiple Sclerosis
The purpose of this study is to determine the effects, both good and bad, of IPX056 on subjects and their spasticity. This study will also determine the relationship between the amount of IPX056 in blood and the effects on…
- Trial name
- NCT00488839
- Testing
- IPX056 20 mg, IPX056 40 mg, Encapsulated Baclofen 20 mg
- Where
- 31 sites in United States, Canada and 3 more
- Volunteers
- 173 people
- Sponsor
- Impax Laboratories, LLC
Bladder Cancer
Vicinium Treatment for Subjects With Non-muscle Invasive Bladder Cancer Previously Treated With BCG
Because of the high risk for development of muscle invasive disease, cystectomy is recommended for CIS, high-grade Ta and T1 patients who experience disease recurrence following intravesical therapy.
- Trial name
- VISTA (NCT02449239)
- Testing
- Vicinium
- Where
- 70 sites in United States, Canada
- Volunteers
- 133 people
- Sponsor
- Sesen Bio, Inc.
HSP, Hereditary Spastic Paraplegia
Safety and Efficacy of AAV9/AP4B1 (BFB-101) For Patients With AP4B1-related Hereditary Spastic Paraplegia Type 47 (SPG47)
Safety and Efficacy of AAV9/AP4B1 For Patients with AP4B1-related Hereditary Spastic Paraplegia Type 47 (SPG47): A Phase 1/2 Single-Center, Open-Label Study of Stereotactic Intra-cisterna Magna Administration.
- Conditions
- HSP, Hereditary Spastic Paraplegia, Hereditary Spastic Paraparesis, Hereditary Spastic Paraplegia Type 50
- Trial name
- NCT06948019
- Testing
- BFB-101 (AAV9-CBh-AP4B1)
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- BlackfinBio Ltd
Dermatomyositis
A Study to Investigate the Efficacy and Safety of Brepocitinib in Adults With Dermatomyositis
This is a phase 3, multicenter, randomized, placebo-controlled, double-blind study of treatment with brepocitinib (TYK2/JAK1 inhibitor) in adults with dermatomyositis (DM).
- Trial name
- VALOR (NCT05437263)
- Testing
- Brepocitinib
- Where
- 109 sites in United States, Argentina and 20 more
- Volunteers
- 241 people
- Sponsor
- Priovant Therapeutics, Inc.
Diabetes Mellitus, Type 2, Skeletal Muscle Insulin Sensitivity
Effects of 5 Weeks Treatment With Dapagliflozin in Type 2 Diabetes Patients on How the Hormone Insulin Acts on Sugar Uptake in Muscles.
The purpose of this study is to investigate the effects of 5 weeks treatment with dapagliflozin in type 2 diabetes patients on how the hormone insulin acts on sugar uptake in muscles.
- Trial name
- DAPAMAAST (NCT03338855)
- Testing
- Dapagliflozin
- Where
- Netherlands
- Volunteers
- 26 people
- Sponsor
- AstraZeneca
Spinal Muscular Atrophy
Pre-Symptomatic Study of Intravenous Onasemnogene Abeparvovec-xioi in Spinal Muscular Atrophy (SMA) for Patients With Multiple Copies of SMN2
To evaluate the safety and efficacy of intravenous onasemnogene abeparvovec-xioi in pre-symptomatic patients with SMA and 2 or 3 copies SMN2
- Trial name
- SPR1NT (NCT03505099)
- Testing
- onasemnogene abeparvovec-xioi
- Where
- 16 sites in United States, Australia and 4 more
- Volunteers
- 30 people
- Sponsor
- Novartis Gene Therapies
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