Safety and Efficacy of Isomyosamine in Reducing Inflammation and Treating Muscle Loss in Older Adults After Hip or Thigh Bone Fractures

Официальное название

Double Blind Placebo-Controlled Parallel Group Study Of Safety And Efficacy Of Isomyosamine In Treating Sarcopenia After Hip Or Femoral Fracture In Gerontological Population

Обзор

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.

Вмешательства

• Препарат Isomyosamine 250mg
  Isomyosamine 250 mg capsules dosed 4 times daily
• Препарат Placebo 250 mg
  Placebo 250 mg capsule 4 times daily

Первичные конечные точки

• Change in Short Physical Performance Battery (SPPB) Test in subjects treated with Isomyosamine or placebo [Срок оценки: From enrollment to the end of treatment at 90 days]

Вторичные конечные точки (5)

• 4-meter walk test [Срок оценки: From enrollment to the end of treatment at 90 days]
• 6-minute walk test [Срок оценки: From enrollment to the end of treatment at 90 days]
• Grip strength [Срок оценки: From enrollment to the end of treatment at 90 days]
• Effect on serum levels of biochemical markers of TNF activation [Срок оценки: From enrollment to the end of treatment at 90 days]
• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 in the Isomyosamine vs Placebo groups [Срок оценки: From enrollment to the end of treatment at 90 days]

Критерии участия

Критерии включения

• 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

And one or more of the following criteria:

• Previous history frailty or sarcopenia diagnosis using standardized tests;
• Positive assessment for frailty or sarcopenia using standardized tests or as per clinician's judgement;
• Previous positive assessment for elevated biomarkers of inflammation (serum IL-6 level> LOQ, TNFR1 level > LOQ, and/or TNF-alpha level > LOQ)

Критерии исключения

• Receiving immunotherapy for cancer or solid organ transplantation
• Complex or comminuted fracture or fracture of multiple long bones
• Regular treatment for chronic disease including chronic renal failure, chronic heart failure (CHF) cerebrovascular disease including stroke, rheumatoid arthritis, or polymyalgia rheumatica
• Chronic kidney disease (estimated glomerular filtration rate \[eGFR\] <60 mL/min)
• Newly (< 2 weeks) diagnosed COVID-19
• 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
• History of neurological, hepatic, renal, diabetic mellitus, thyroid disorder, psychiatric, addiction or other medical conditions that may interfere with the interpretation of data or the patient's participation in the study or may increase safety concerns per investigator discretion
• Currently under treatment by an anti-TNFα drug, such as adalimumab, etanercept, infliximab, certolizumab pegol, golimumab, and biosimilars
• Currently under treatment by an anti-diabetic medication, including glucagon-like peptide-1 (GLP-1) drugs such as semaglutide, or any of metformin, jenuvia, or insulin
• Unwillingness or inability to comply with study procedures, including smoking cessation
• History of epilepsy or seizure propensity, ataxia, abnormal EEG findings, abnormal brain magnetic resonance image, or other co-morbid neurological conditions
• Positive TB test
• Patients who are pregnant or breastfeeding

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06942182 · TNF001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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