Clinical trials: Wasting Syndrome
ICU Acquired Weakness
Evaluation of FDY-5301 in Major Trauma Patients in ICU
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of FDY-5301 compared to placebo in major trauma ICU patients at risk of intensive care unit acquired weakness (ICUAW)
- Trial name
- NCT04430283
- Testing
- FDY-5301
- Where
- 5 sites in United States
- Volunteers
- 8 people
- Sponsor
- Faraday Pharmaceuticals, Inc.
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
Chronic Obstructive Pulmonary Disease (COPD)
Efficacy and Safety Study of Tesamorelin in Chronic Obstructive Pulmonary Disease (COPD) Subjects With Muscle Wasting
A significant proportion of COPD subjects experience muscle wasting, which has been associated with increased morbidity, impaired physical functioning, and a poor quality of life.
- Trial name
- NCT01388920
- Testing
- Tesamorelin
- Volunteers
- 3 people
- Sponsor
- Theratechnologies
HIV Infections, Cachexia
Evaluate Weight Gain Using 2 Different Formulations of Megestrol Acetate Oral Suspension for AIDS-related Weight Loss
Explore weight gain in HIV-positive patients who have weight loss associated with AIDS-related wasting (anorexia/cachexia). Patients are treated for 12 weeks with either megestrol acetate oral suspension nanocrystal dispersion…
- Conditions
- HIV Infections, Cachexia, Anorexia, AIDS Wasting Syndrome
- Trial name
- NCT00637572
- Testing
- Megestrol acetate oral suspension nanocrystal dispersion 115 mg/mL, Megestrol acetate oral suspension 40 mg/mL
- Where
- 12 sites in United States, India and 1 more
- Volunteers
- 63 people
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
Pulmonary Tuberculosis, Body Weight Changes
Fermented Soybean Supplementation Among Active Pulmonary Tuberculosis Patients With Standard Therapy in Indonesia
Tuberculosis (TB) patients often have a lower body mass index (BMI) and experience wasting. Wasting reduces lean body mass and may cause physical function impairment.
- Conditions
- Pulmonary Tuberculosis, Body Weight Changes, Motor Activity
- Trial name
- FSS (NCT02554318)
- Testing
- Rifampicin, Isoniazid, Pyrazinamide
- Volunteers
- 147 people
- Sponsor
- University of Giessen
Cancer
Cyproheptadine in Preventing Weight Loss in Children Receiving Chemotherapy for Cancer
RATIONALE: Cyproheptadine hydrochloride may prevent weight loss caused by cancer or cancer treatment. It is not yet known whether cyproheptadine is more effective than a placebo in preventing weight loss in young patients…
- Trial name
- NCT01132547
- Testing
- cyproheptadine hydrochloride
- Where
- 14 sites in United States
- Volunteers
- 22 people
- Sponsor
- University of South Florida
Type 2 Spinal Muscular Atrophy
Efficacy and Safety of Intrathecal OAV101 (AVXS-101) in Pediatric Patients With Type 2 Spinal Muscular Atrophy (SMA)
This was a Phase III multi-center, single dose (1.2 x 10^14 vector genomes), randomized, sham controlled, double-blind study that investigates the efficacy, safety and tolerability of OAV101B in treatment naive, sitting and never…
- Trial name
- STEER (NCT05089656)
- Testing
- OAV101
- Where
- 42 sites in United States, Brazil and 11 more
- Volunteers
- 126 people
- Sponsor
- Novartis Pharmaceuticals
Muscular Atrophy, Spinal
Safety and Efficacy of Intravenous OAV101 (AVXS-101) in Pediatric Patients With Spinal Muscular Atrophy (SMA) (OFELIA)
This was a phase IV Open-label, single-arm, single-dose, multicenter study, to evaluate the safety, tolerability and efficacy of intravenous administration of OAV101 (AVXS-101) in patients with SMA with bi-allelic mutations in…
- Trial name
- OFELIA (NCT05073133)
- Testing
- OAV101
- Where
- 5 sites in Argentina, Brazil
- Volunteers
- 16 people
- Sponsor
- Novartis Pharmaceuticals
Spinal Muscular Atrophy
Phase IIIb, Open-label, Multi-center Study to Evaluate Safety, Tolerability and Efficacy of OAV101 Administered Intrathecally to Participants With SMA Who Discontinued Treatment With Nusinersen or Risdiplam
This was a Phase IIIb open-label, single arm, multi-center study to evaluate the safety, tolerability and efficacy of OAV101B in participants with SMA aged 2 to <18 years after the discontinuation of treatment with nusinersen or…
- Trial name
- STRENGTH (NCT05386680)
- Testing
- OAV101
- Where
- 13 sites in United States, Australia and 7 more
- Volunteers
- 27 people
- Sponsor
- Novartis Pharmaceuticals
Stage IV Non-small Cell Lung Cancer, Cachexia
Ruxolitinib for Cancer Cachexia
To assess toxicity with use of Ruxolitinib in NSCLC cachexia patients; to associate levels of JAK/STAT signaling in blood, adipose, and muscle pre- and post-ruxolitinib treatment with changes in cachexia and anorexia.
- Trial name
- NCT04906746
- Testing
- Identify any dose-limiting toxicity (DLT) when ruxolitinib is administered to NSCLC cachexia patients.
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Tu Dan
Muscle Wasting, Non-Small Cell Lung Cancer
Effect of GTx-024 on Muscle Wasting in Patients With Non-Small Cell Lung Cancer (NSCLC) on First Line Platinum
The purpose of this study is to determine if the investigational drug GTx-024 can help patients with non small cell lung cancer increase physical function and maintain or gain muscle.
- Trial name
- NCT01355497
- Testing
- GTx-024
- Where
- 30 sites in United States
- Volunteers
- 330 people
- Sponsor
- GTx
Malnutrition, Wasting
Nutritional Impact of Moringa Oleifera Leaf Supplementation in Mothers and Children
Studies to date on the effects of Moringa oleifera in diabetes and anemia and animal studies that examine the utility of moringa for increased milk and litter yield are of small scale, however high-quality large-scale placebo or…
- Conditions
- Malnutrition, Wasting, Growth Failure
- Trial name
- NCT04587271
- Testing
- Moringa oleifera (high dose), Moringa oleifera (low dose)
- Where
- 2 sites in Kenya
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Suzanna L Attia
Chronic Obstructive Pulmonary Disease (COPD) With Cachexia
BYM338 in Chronic Obstructive Pulmonary Disease (COPD) Patients With Cachexia
This study will assess the pharmacodynamics, pharmacokinetics, safety and tolerability of BYM338 in patients with COPD and cachexia. The primary outcome will be a change in thigh muscle volume compared to placebo.
- Trial name
- NCT01669174
- Testing
- BYM338
- Where
- 9 sites in United States, Netherlands and 1 more
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Cachexia
Clinical Study of BYM338 for the Treatment of Unintentional Weight Loss in Patients With Cancer of the Lung or the Pancreas
A safety \& efficacy clinical study of the investigational medicinal product BYM338 for the treatment of unintentional weight loss in patients with cancer of the lung or the pancreas
- Trial name
- NCT01433263
- Testing
- BYM338 active drug
- Where
- 10 sites in United States, Lithuania and 3 more
- Volunteers
- 57 people
- Sponsor
- Novartis Pharmaceuticals
End Stage Renal Disease (ESRD)
Effect of Medium Cut-Off Hemodialysis on Protein Energy Wasting: The EMCOPEW Study
In patients on maintenance hemodialysis (HD), protein energy wasting (PEW) defined as loss of muscle mass and fuel reserves of the body is frequent and associated with severe morbidity and mortality.
- Trial name
- EMCOPEW (NCT05309109)
- Testing
- Hemodialysis sessions
- Where
- 2 sites in France
- Volunteers
- 65 people
- Sponsor
- Poitiers University Hospital
Sporadic Inclusion Body Myositis
An Extension Study of the Efficacy, Safety and Tolerability of BYM338 (Bimagrumab) in Patients With Sporadic Inclusion Body Myositis Who Previously Participated in the Core Study CBYM338B2203
This extension study will provide data to further evaluate the efficacy, safety, and tolerability of three doses of BYM338 and to assess the long-term effects of BYM338 in patients with sporadic inclusion body myositis.
- Trial name
- NCT02573467
- Testing
- Bimagrumab
- Where
- 38 sites in United States, Australia and 8 more
- Volunteers
- 211 people
- Sponsor
- Novartis Pharmaceuticals
Spinal Muscular Atrophy
Safety and Efficacy of Intravenous OAV101 (AVXS-101) in Pediatric Patients With Spinal Muscular Atrophy (SMA)
To evaluate the safety, tolerability and efficacy of intravenous administration of OAV101 (AVXS-101) in patients with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene weighing ≥…
- Trial name
- SMART (NCT04851873)
- Testing
- OAV101
- Where
- 13 sites in United States, Australia and 7 more
- Volunteers
- 24 people
- Sponsor
- Novartis Pharmaceuticals
HIV Lipodystrophy
Combination of Insulin Sensitizer and Leptin as Treatment for the HAART -Induced Metabolic Syndrome
The purpose of this study is to determine whether patients with HIV lipodystrophy (fat wasting) benefit from taking the combination of two drugs, one insulin sensitizer (either metformin or pioglitazone, both diabetes drugs) and…
- Trial name
- NCT00362440
- Testing
- Leptin, Pioglitazone or metformin
- Where
- United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Beth Israel Deaconess Medical Center
Stunting, Wasting
Complementary Food Supplements for Reducing Childhood Undernutrition
The purpose of this study is to test the impact on child growth of three specially formulated complementary food supplements vs. Plumpy'Doz, a previously tested, commercially available complementary food, and vs.
- Trial name
- NCT01562379
- Testing
- Wheat Soy Blend (WSB++), Chickpea based complementary food supplement, Rice based complementary food supplement
- Where
- Bangladesh
- Volunteers
- 5,449 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
Undernutrition, Wasting
Evaluating Oral Nutritional Supplements on Children's Nutritional Status and Digestive Health in Vietnam.
Evaluating the efficiency of using Oral Nutritional Supplementation toward nutrition status (anthropometric index, the prevalence of wasting), digestive disorders, and anorexic in children aged 24 - 71 months.
- Conditions
- Undernutrition, Wasting, Malnourished
- Trial name
- NCT05551637
- Testing
- Kazu Gain Gold
- Where
- Vietnam
- Volunteers
- 600 people
- Sponsor
- Tu Nguyen Song