Clinical trials: Muscle Hypotrophy
SMA - Spinal Muscular Atrophy
Safety and Efficacy Evaluation of GC101 Gene Therapy Via Intrathecal (IT) Injectionin the Treatment of Patients With Type 2 Spinal Muscular Atrophy (SMA) - Phase III
This trial employs a multicenter, randomized, open-label, standard-of-care-controlled design and plans to enroll 50 patients with Type 2 SMA aged 2 to 12 years who have previously received nusinersen.
- Trial name
- NCT06971094
- Testing
- GC101 adeno-associated virus injection
- Where
- 7 sites in China
- Volunteers
- 50 people
- Sponsor
- GeneCradle Inc
Malnutrition, Sarcopenia
Evaluation of an Oral Nutritional Supplement Containing AN777
To evaluate the effect of an experimental oral nutritional supplement containing AN777 compared to another oral nutritional supplement in a malnourished, elderly population.
- Trial name
- NCT01191125
- Testing
- medical food with AN777, oral nutritional formula
- Where
- 23 sites in United States, Belgium and 6 more
- Volunteers
- 331 people
- Sponsor
- Abbott Nutrition
Spinal Muscular Atrophy
A Study to Assess the Efficacy and Safety of Nusinersen (ISIS 396443) in Participants With Later-onset Spinal Muscular Atrophy (SMA)
The primary objective of this study is to examine the clinical efficacy of nusinersen (ISIS 396443) administered intrathecally to participants with later-onset Spinal Muscular Atrophy (SMA).
- Trial name
- CHERISH (NCT02292537)
- Testing
- Nusinersen
- Where
- 24 sites in United States, Canada and 8 more
- Volunteers
- 126 people
- Sponsor
- Biogen
Spinal Muscular Atrophy
An Open Label Study of Gene Therapy Product (Vesemnogene Lantuparvovec) in Spinal Muscular Atrophy
This is an interventional study to evaluate safety and efficacy of AAV-hSMN1 in spinal muscular atrophy patients.
- Trial name
- NCT06288230
- Testing
- vesemnogene lantuparvovec
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Lantu Biopharma
Spinal Muscular Atrophy Type II, Spinal Muscular Atrophy Type III Non Ambulant
Safety and Efficacy of Olesoxime (TRO19622) in 3-25 Years SMA Patients.
Assess the efficacy and the safety of olesoxime in SMA type 2 or type 3 non ambulant patients aged 3-25 years
- Trial name
- NCT01302600
- Testing
- Olesoxime
- Where
- 22 sites in Belgium, France and 5 more
- Volunteers
- 165 people
- Sponsor
- Hoffmann-La Roche
Low Muscle Strength, Malnutrition
Efficacy of Oral Nutritional Supplement in Community-Dwelling Adults Following Acute Care
The study aims to determine the effects of Oral Nutritional Supplement (ONS) added to usual care on body weight compared with usual care alone in community-dwelling adults aged 55 years and older who are at risk of malnutrition…
- Trial name
- NCT07753239
- Testing
- ONS, Standard of Care (SOC)
- Where
- 7 sites in Thailand
- Volunteers
- 304 people
- Sponsor
- Abbott Nutrition
Muscular Atrophy, Spinal
A Study to Investigate the Pharmacokinetics and Safety of Risdiplam in Infants With Spinal Muscular Atrophy
This study will evaluate the pharmacokinetics (PK) and safety of risdiplam in participants with spinal muscular atrophy (SMA) under 20 days of age at first dose.
- Trial name
- PUPFISH (NCT05808764)
- Testing
- Risdiplam
- Where
- 13 sites in United States, Belgium and 6 more
- Volunteers
- 11 people
- Sponsor
- Hoffmann-La Roche
Spinal Muscular Atrophy Type I, Spinal Muscular Atrophy Type II
Therapeutic Management and Use of Resources and Costs of Spinal Muscular Atrophy in Spain
An observational, retrospective, cross-sectional, multicenter study. Real-world data were obtained from medical records of Spanish public hospitals (9 hospitals).
- Trial name
- NCT06632730
- Where
- United States
- Volunteers
- 69 people
- Sponsor
- Novartis
SMA
EAP of Apitegromab for Patients With Spinal Muscular Atrophy
The purpose of this expanded access program (EAP) is to provide access to apitegromab for eligible patients with spinal muscular atrophy (SMA) prior to approval by the local regulatory agency .
- Trial name
- NCT06877689
- Testing
- Apitegromab
- Sponsor
- Scholar Rock, Inc.
Muscular Atrophy, Spinal
Bioavailability and Bioequivalence of Two Risdiplam Tablets in Healthy Participants
The study is a randomized, single oral dose, crossover study in up to three parts to investigate the relative bioavailability and bioequivalence of two different formulations of risdiplam 5 mg (dispersible tablets) versus the…
- Trial name
- NCT04718181
- Testing
- risdiplam, omeprazole
- Where
- 4 sites in United States
- Volunteers
- 131 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Muscular Atrophy, Spinal
A Real-World Study of Clinical Use of Available Treatments for Pediatric Patients With Spinal Muscular Atrophy
The aim of this study was to evaluate real-world treatment patterns and clinical outcomes in pediatric SMA patients in the Czech and Slovak Republics, using data from the Registry of muscular Dystrophy (REaDY).
- Trial name
- NCT07474311
- Where
- Czechia
- Volunteers
- 213 people
- Sponsor
- Novartis Pharmaceuticals
Sporadic Inclusion Body Myositis
Efficacy and Safety of Bimagrumab/BYM338 at 52 Weeks on Physical Function, Muscle Strength, Mobility in sIBM Patients
This study evaluated the efficacy, safety and tolerability of multiple doses of bimagrumab/BYM338 vs placebo, when administered intravenously (i.v.), on physical function, muscle strength, and mobility in patients with sporadic…
- Trial name
- RESILIENT (NCT01925209)
- Testing
- BYM338/bimagrumab
- Where
- 38 sites in United States, Australia and 8 more
- Volunteers
- 251 people
- Sponsor
- Novartis Pharmaceuticals
Ulcerative Colitis (Disorder), Crohn Disease
Partial Enteral Nutrition to Prevent Weight Loss and Sarcopenia in IBD Patients at Nutritional Risk - SIMBA
This is a multicenter, open-label, randomized two-arm interventional nutritional study evaluating the effects of partial enteral nutrition (LH VIOLA) in patients with Inflammatory Bowel Disease (IBD) at risk of malnutrition.
- Conditions
- Ulcerative Colitis (Disorder), Crohn Disease, Malnutrition or Risk of Malnutrition, IBD
- Trial name
- SIMBA (NCT07433946)
- Testing
- LH VIOLA Supplementation
- Where
- 4 sites in Italy
- Volunteers
- 146 people
- Sponsor
- Lionhealth Srl Società Benefit
Sarcopenia in Elderly, Malnourished
The Effects of MediDrink Platinum+ and Fava Bean Protein Hydrolysate on Fitness in an Aged Population
Examining the effects of MediDrink Platinum+ containing novel protein blend SRP-01 alone or when combined with PeptiStrong on clinical responses in elderly adults with sarcopenia
- Conditions
- Sarcopenia in Elderly, Malnourished, Protein Supplementation, Muscle Mass
- Trial name
- NCT07322653
- Testing
- MediDrink Platinum+, MediDrink Platinum+ and PeptiStrong
- Where
- 2 sites in Hungary
- Volunteers
- 75 people
- Sponsor
- Nuritas Ltd
Spinal Muscular Atrophy
A Long-term Follow-up Study Evaluating Intravenous Injection of EXG001-307 in Patients With Type 1 SMA
An Open-label, Long-term Follow-Up Study to Evaluate the Safety and Tolerability of Gene Therapy with EXG001-307 in SMA1 patients ,who joined the parent study (EXG001-307-102)
- Trial name
- NCT06588803
- Testing
- No intervention, only for observational studies
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Guangzhou Jiayin Biotech Ltd
Muscular Atrophy
A Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACE-031 in Healthy Postmenopausal Women
The purpose of this study is to establish safe dose levels of ACE-031 in healthy postmenopausal women following multiple dose administration. This study will also evaluate if ACE-031 has an effect on muscle.
- Trial name
- NCT00952887
- Testing
- ACE-031
- Where
- 2 sites in Canada
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Age-related Muscle Decline
CALM-AF-AI: Counteracting Age-related Loss of Muscle With AAV-Follistatin Combined With Angiogenesis-Inducing VEGF Plasmid Gene Therapy
This Phase 1/2a, open-label, non-randomized study is designed to evaluate the safety and tolerability of intramuscular AAV9-Follistatin gene therapy administered either as monotherapy or in combination with a VEGF-encoding…
- Trial name
- CALM-AF-AI (NCT07443826)
- Testing
- AAV9-Follistatin gene therapy, VEGF Plasmid
- Where
- Honduras
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Unlimited Biotechnology LLC
Muscular Atrophy, Spinal
Pediatric Spinal Muscular Atrophy (SMA) China Registry
The primary objective of the study is to describe the natural history and utilization of disease modifying therapy (DMT) treatments among pediatric Chinese participants with spinal muscular atrophy linked to chromosome 5q…
- Trial name
- NCT05042921
- Where
- 25 sites in China
- Volunteers
- 600 people
- Sponsor
- Biogen
Healthy Volunteer, Atrophy, Muscular
A Clinical Study to Assess the Effects of SRT2104 Upon Immobilization-Induced Skeletal Muscle Atrophy in Healthy Human Volunteers
The main purpose of this study is to investigate the effect of SRT2104 upon energy production in muscle (specifically the maximum amount of energy produced with muscle contraction), how much sugar and fat are stored in the…
- Trial name
- NCT01039909
- Testing
- SRT2104
- Volunteers
- healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy Volunteer, Muscular Atrophy, Spinal
A Study to Learn About the Safety of BIIB115 Injections and How BIIB115 is Processed in the Bodies of Healthy Adult Male Volunteers and of Pediatric Participants With Spinal Muscular Atrophy Who Previously Took Onasemnogene Abeparvovec
In this study, researchers will learn about a study drug called BIIB115 in healthy adult male volunteers and in participants with spinal muscular atrophy (SMA). This study will focus on children with SMA.
- Trial name
- NCT05575011
- Testing
- BIIB115
- Where
- 16 sites in Belgium, Canada and 7 more
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Biogen