Clinical trials: Muscle Disorders
Bladder Cancer, Urothelial Carcinoma
Feasibility of Home Instillation of UGN-102 for Treatment of Low-Grade (LG) Non-Muscle Invasive Bladder Cancer (NMIBC)
This study aims to demonstrate that home instillation of UGN-102 is a feasible alternative to instillation in a clinical setting, which might mitigate patient challenges (logistical, expense, and comfort) when receiving treatment…
- Conditions
- Bladder Cancer, Urothelial Carcinoma, Urothelial Carcinoma Bladder
- Trial name
- NCT05136898
- Testing
- UGN-102
- Where
- 5 sites in United States
- Volunteers
- 8 people
- Sponsor
- UroGen Pharma Ltd.
Autosomal Dominant Hypocalcemia
ADH1 and ADH2 Disease Monitoring Study (DMS)
A global, multi-center, Disease Monitoring Study (DMS) in participants with Autosomal Dominant Hypocalcemia Type 1 (ADH1) or Autosomal Dominant Hypocalcemia Type 2 (ADH2) designed to characterize ADH1 and ADH2 disease…
- Trial name
- CLARIFY (NCT05227287)
- Where
- 27 sites in United States, Australia and 11 more
- Volunteers
- 95 people
- Sponsor
- Calcilytix Therapeutics, Inc., a BridgeBio company
Becker Muscular Dystrophy
Open-Label Extension of EDG-5506 in Participants With Becker Muscular Dystrophy
EDG-5506-203 MESA is an open-label extension study to assess the long-term effect of sevasemten (EDG-5506) on safety, biomarkers, and functional measures in adults and adolescents with Becker muscular dystrophy
- Trial name
- MESA (NCT06066580)
- Testing
- Sevasemten
- Where
- 48 sites in United States, Australia and 10 more
- Volunteers
- 260 people
- Sponsor
- Edgewise Therapeutics, Inc.
Bladder Cancer
Perioperative Enfortumab Vedotin (EV) Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Chemotherapy for Cisplatin-Eligible Muscle Invasive Bladder Cancer (MIBC) (MK-3475-B15/ KEYNOTE-B15 / EV-304)
The purpose of this study is to assess the antitumor efficacy and safety of perioperative enfortumab vedotin (EV) plus pembrolizumab and radical cystectomy (RC) + pelvic lymph node dissection (PLND) compared with the current…
- Trial name
- KEYNOTE-B15 (NCT04700124)
- Testing
- Pembrolizumab, Enfortumab vedotin (EV), RC + PLND
- Where
- 188 sites in United States, Argentina and 27 more
- Volunteers
- 808 people
- Sponsor
- Merck Sharp & Dohme LLC
Myotonic Dystrophy 1
Effect of MYODM on Quality of Life, Fatigue and Hypersomnia in Patients With Myotonic Dystrophy Type 1
The purpose of this study is to determine whether MYODM (formulated composition containing Theobroma cacao supplemented with caffeine (caffeine/theobromine ratio1/1.85, w/w) is effective in the treatment of excessive daytime…
- Trial name
- NCT04634682
- Testing
- MYODM
- Where
- Spain
- Volunteers
- 30 people
- Sponsor
- Myogem Health Company, S.L.
Cerebral Palsy, Muscle Spasticity
Dysport® Pediatric Lower Limb Spasticity Follow-on Study
The purpose of this research study was to determine the long term safety and efficacy of repeated treatments with Dysport® used in the treatment of lower limb spasticity in children with dynamic equinus foot deformity due to…
- Conditions
- Cerebral Palsy, Muscle Spasticity, Children
- Trial name
- NCT01251380
- Testing
- Botulinum toxin type A
- Where
- 27 sites in United States, Chile and 4 more
- Volunteers
- 216 people
- Sponsor
- Ipsen
Duchenne Muscular Dystrophy (DMD)
A Phase 2 Trial to Investigate the Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Tegacorat in Male Participants 4 to <7 Years of Age With Duchenne Muscular Dystrophy
This Phase 2 clinical trial will evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of tegacorat oral solution in male participants 4 to less than 7 years of age with Duchenne muscular dystrophy…
- Trial name
- NCT07911995
- Testing
- Tegacorat
- Volunteers
- 36 people
- Sponsor
- Grünenthal GmbH
Muscular Disorders, Atrophic, Muscular Diseases
Managed Access Program for Del-zota in Participants With DMD Mutations Amenable to Exon 44 Skipping
The purpose of this Managed Access Program is to allow access to delpacibart zotadirsen (AOC 1044) for eligible patients diagnosed with DMD mutations amenable to exon 44 skipping.
- Conditions
- Muscular Disorders, Atrophic, Muscular Diseases, Musculoskeletal Diseases, Neuromuscular Diseases
- Trial name
- NCT07250737
- Testing
- delpacibart zotadirsen
- Where
- 22 sites in United States
- Sponsor
- Avidity Biosciences, Inc.
Amyotrophic Lateral Sclerosis (ALS)
Placebo Controlled Study of ONO2506PO in the Presence of Riluzole in Patients With Amyotrophic Lateral Sclerosis (ALS)
The purpose of this study is to determine if oral treatment with ONO-2506PO in patients diagnosed with ALS, who have had onset of muscle weakness within 14 months of randomization, could lead to the slowing of decline in…
- Trial name
- NCT00403104
- Testing
- ONO-2506PO
- Where
- 26 sites in Austria, Belgium and 6 more
- Volunteers
- 420 people
- Sponsor
- Ono Pharmaceutical Co., Ltd.
Spasticity
Long-term Surveillance of the MedStream Programmable Infusion System
This post-approval study will primarily evaluate the long-term safety of the MedStream Programmable Infusion System when used in combination with Baclofen for the treatment of severe spasticity.
- Trial name
- NCT01712087
- Testing
- MedStream Programmable Infusion System
- Where
- 2 sites in United States
- Volunteers
- 2 people
- Sponsor
- Codman & Shurtleff
Fibromyalgia Syndrome, Primary
Fibromyalgia Study In Adults
A study to investigate ropinirole for treatment of the symptoms of fibromyalgia and in particular the widespread pain associated with this condition.
- Trial name
- NCT00256893
- Testing
- ropinirole
- Where
- 22 sites in Belgium, Denmark and 7 more
- Volunteers
- 164 people
- Sponsor
- GlaxoSmithKline
Facioscapulohumeral Muscular Dystrophy (FSHD)
A Study of SAT-3247 to Evaluate the Safety, Tolerability, and Efficacy in Participants With Facioscapulohumeral Muscular Dystrophy (FSHD)
This is a two-part, Phase 2, randomized, placebo-controlled, double-blind study, followed by a randomized active treatment period, to evaluate the safety and efficacy of orally administered forazapadin (SAT-3247) in adult…
- Trial name
- NCT07872306
- Testing
- forazapadin
- Volunteers
- 51 people
- Sponsor
- Satellos Bioscience, Inc.
Idiopathic Inflammatory Myositis
A Phase 2 Proof of Concept Study to Evaluate the Efficacy and Safety of Daxdilimab in Participants With Dermatomyositis (DM) or Anti-synthetase Inflammatory Myositis (ASIM)
The primary efficacy objective: To evaluate the effect of daxdilimab compared with placebo in reducing disease activity at Week 24. The secondary efficacy objectives include: 1.
- Trial name
- NCT05669014
- Testing
- Daxdilimab
- Where
- 9 sites in United States, Brazil and 4 more
- Volunteers
- 12 people
- Sponsor
- Amgen
Polymyalgia Rheumatica
Sarilumab Efficacy and Safety in Adults With Early Polymyalgia Rheumatica
This is a randomized, double-blind, placebo-controlled, parallel-group, Phase 3, 3-arm study to assess whether treatment with sarilumab at either 150 mg q2w (once every two weeks) or at 200 mg q2w, each given with a 52-week…
- Trial name
- ZIRCON (NCT07286214)
- Testing
- Sarilumab
- Where
- 85 sites in United States, Austria and 8 more
- Volunteers
- 300 people
- Sponsor
- Sanofi
Juvenile Dermatomyositis (JDM), Polyarticular Juvenile Idiopathic Arthritis
Clinical Study of BCMA/CD70-targeted CAR-T Therapy for Refractory Pediatric Rheumatic Diseases
This is an investigator-initiated trial to evaluate the efficacy and safety of BCMA/CD70-targeted CAR-T in the treatment of refractory pediatric rheumatic diseases.
- Conditions
- Juvenile Dermatomyositis (JDM), Polyarticular Juvenile Idiopathic Arthritis, Systemic Sclerosis (SSc), Primary Sjogren's Syndrome
- Trial name
- NCT07184450
- Testing
- BCMA/CD70-targetd CAR-T
- Where
- China
- Volunteers
- 11 people
- Sponsor
- Chongqing Precision Biotech Co., Ltd
Liver Cirrhosis, Sarcopenia
A Study to Assess the Efficacy, Safety, and Tolerability of Oral LPCN 1148 in Male Subjects With Cirrhosis of the Liver and Sarcopenia
This is a randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of LPCN 1148 in men with cirrhosis of the liver and sarcopenia.
- Trial name
- NCT04874350
- Testing
- LPCN 1148
- Where
- 10 sites in United States
- Volunteers
- 30 people
- Sponsor
- Lipocine Inc.
Spinal Muscular Atrophy, Spinal Muscular Atrophy Type 3
Long-Term Safety & Efficacy of Apitegromab in Patients With SMA Who Completed Previous Trials of Apitegromab
The ONYX study is an Open-Label, Multicenter, Extension study that will evaluate the long-term safety and efficacy of Apitegromab in Patients with Type 2 and Type 3 SMA who have completed TOPAZ or SAPPHIRE.
- Conditions
- Spinal Muscular Atrophy, Spinal Muscular Atrophy Type 3, Spinal Muscular Atrophy Type 2, SMA
- Trial name
- ONYX (NCT05626855)
- Testing
- Apitegromab
- Where
- 49 sites in United States, Belgium and 7 more
- Volunteers
- 238 people
- Sponsor
- Scholar Rock, Inc.
Limb-Girdle Muscular Dystrophy
A Study of Deflazacort (Emflaza®) in Participants With Limb-Girdle Muscular Dystrophy 2I (LGMD2I)
This study is designed to evaluate the safety and efficacy of deflazacort in participants with LGMD2I. Most participants enrolled will have a screening visit and 3 additional visits (after 1, 13, and 26 weeks of treatment).
- Trial name
- NCT03783923
- Testing
- Deflazacort
- Where
- 18 sites in United States, Canada and 6 more
- Volunteers
- 11 people
- Sponsor
- PTC Therapeutics
Carcinoma in Situ, Transitional Cell Carcinoma
Multi-center Study to Evaluate the Efficacy and Safety of Maintenance Therapy With Valrubicin Versus no Maintenance, in Subjects Treated With Valrubicin Induction for Carcinoma in Situ (CIS) of the Bladder
This is a Phase 3b open-label, randomized, parallel-arm, multicenter study to evaluate the efficacy and safety of 10 monthly intravesical administrations of maintenance therapy with valrubicin following induction with valrubicin…
- Conditions
- Carcinoma in Situ, Transitional Cell Carcinoma, Non-muscle Invasive Bladder Cancer
- Trial name
- NCT01310803
- Testing
- VALSTAR - Maintenance Therapy, No Maintenance treatment ( Standard of Care)
- Where
- 6 sites in United States
- Volunteers
- 1 people
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
Non-muscle Invasive Bladder Cancer, NMIBC
A Phase 1 Dose-escalation Study of UGN-301 in Patients With Recurrent Non-muscle Invasive Bladder Cancer (NMIBC)
This study is being conducted to evaluate the safety and determine the recommended Phase 2 dose (RP2D) of UGN-301 (zalifrelimab) administered intravesically as monotherapy and in combination with other agents in patients with…
- Conditions
- Non-muscle Invasive Bladder Cancer, NMIBC, Carcinoma in Situ of Bladder, Bladder Cancer
- Trial name
- NCT05375903
- Testing
- UGN-301, UGN-201, Gemcitabine
- Where
- 13 sites in United States, Italy and 1 more
- Volunteers
- 51 people
- Sponsor
- UroGen Pharma Ltd.
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