Safety and Efficacy of Isomyosamine in Reducing Inflammation and Treating Muscle Loss in Older Ad… (NCT06942182) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Safety and Efficacy of Isomyosamine in Reducing Inflammation and Treating Muscle Loss in Older Adults After Hip or Thigh Bone Fractures
60 participantsStarted 2025-05-01
Plain-language summary
This Phase II clinical study investigates the safety and effectiveness of a new drug, Isomyosamine, in patients with sarcopenia or frailty, conditions associated with aging and muscle weakness. Isomyosamine is a promising oral medication that reduces inflammation by targeting cytokines like TNF-α and IL-6, which are linked to these conditions. Previous studies have shown it is well-tolerated and may help improve muscle strength, mobility, and healing after hip fractures. This trial aims to determine its potential benefits in reducing inflammation and improving recovery in elderly patients.
Who can participate
Age range60 Years – 85 Years
SexALL
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Inclusion criteria
✓. Age 60 to 85 years of age
✓. Non-complex, non-comminuted fracture of the femoral head, femoral neck, or acetabulum due to an accidental (non-neurologic or cardiovascular) fall
✓. Concomitant medication limited to treatment for chronic conditions
✓. The ability to give informed consent and comply with study procedures
✓. Body weight ≥35 kg
✓. Adequate dietary intake
✓. Potential subjects' intention to avoid reproductive activity will be confirmed
✓. Previous history frailty or sarcopenia diagnosis using standardized tests;
Exclusion criteria
✕. Receiving immunotherapy for cancer or solid organ transplantation
✕. Complex or comminuted fracture or fracture of multiple long bones
What they're measuring
1
Change in Short Physical Performance Battery (SPPB) Test in subjects treated with Isomyosamine or placebo
Timeframe: From enrollment to the end of treatment at 90 days
✕. Inability or unwillingness to give written informed consent
✕. History of upper/lower respiratory tract infection, requiring systemic steroids, antibiotics, and or emergency room (ER) visit or urgent care within 6 weeks of screening visit
✕. History of adverse reaction or allergy to TNF inhibitor