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SARA-31: A phase 3 trial to evaluate the efficacy and safety of BIO-101 in elderly patients suffering from severe SARcopeniA: an interventional, randomized double-blind placebo- controlled, clinical trial.
EU CTIS ID: 2022-502417-28-01
What this study is testing
To evaluate the efficacy of BIO101 350 mg b.i.d. administered orally versus placebo on the hazard of major mobility disability (MMD) in non-disabled older patients suffering from sarcopenia.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Aged 65 and older.
- Living in the community (living at home, able to walk outside)
- Reporting a loss of motor function over the last year
- Short Physical Performance Battery (SPPB) score between 3 (included) and 7 (included).
- Able to complete the 400-m walk test within 15 min without sitting down, help fromanother person, or use of a walker, a cane is accepted.
- Hand grip strength in the dominant hand <35.5 kg for men, <20 kg for women
You likely can't join if
- Non-menopaused women (however, ongoing hormonal replacement treatment is notan exclusion criterion)
- Treatment with another investigational drug, 20-hydroxyecdysone food supplements,
- Sarcopenia and/or muscle weakness occurring after bedrest or immobilization (with full recovery less than 6 month before screening).
- Start of participation in a structured physical/rehabilitation therapy less than 3 months before screening (except for passive physical therapy. However, this should not be initiated the week before an evaluation visit and once started, it should be maintained over the study duration).
- Stroke, hip fracture, hip or knee replacement, or spinal surgery in the past 6 months
- Severe arthritis or osteoarthritis in the lower limbs which would impact abilityto perform 400 MWT.
See the full eligibility criteria
- Aged 65 and older.
- Living in the community (living at home, able to walk outside)
- Reporting a loss of motor function over the last year
- Short Physical Performance Battery (SPPB) score between 3 (included) and 7 (included).
- Able to complete the 400-m walk test within 15 min without sitting down, help fromanother person, or use of a walker, a cane is accepted.
- Hand grip strength in the dominant hand <35.5 kg for men, <20 kg for women
- Gait speed from 4-m walking test ≤ 0.8 m/s.
- Non-menopaused women (however, ongoing hormonal replacement treatment is notan exclusion criterion)
- Treatment with another investigational drug, 20-hydroxyecdysone food supplements,
- Sarcopenia and/or muscle weakness occurring after bedrest or immobilization (with full recovery less than 6 month before screening).
- Start of participation in a structured physical/rehabilitation therapy less than 3 months before screening (except for passive physical therapy. However, this should not be initiated the week before an evaluation visit and once started, it should be maintained over the study duration).
- Stroke, hip fracture, hip or knee replacement, or spinal surgery in the past 6 months
- Severe arthritis or osteoarthritis in the lower limbs which would impact abilityto perform 400 MWT.
- Parkinson’s disease or other progressive neurological disorder
- Lung disease requiring regular use of supplemental oxygen.
- Severe cardiovascular disease(including New York Heart Association [NYHA]class III or IV congestive heart failure, clinically significant valvular disease,(history of cardiac arrest, presence of an implantable defibrillator, oruncontrolled angina).
- Chest pain, severe shortness of breath, or occurrence of other safety concernsduring the baseline functional tests such as the 400MW test.
- Renal disease requiring dialysis or known renal insufficiency (moderate orsevere reduction of eGFR≤30 ml/min/1.73 m2, based on Cockroft & Gaultformula).
- History or active signs or symptoms of gallbladder/biliary disease (e.g., previousepisodes of cholestasis/biliary tract obstruction, cholelithiasis, cholecystitis,etc.). Of note, history of cholecystectomy and no active biliary signs orsymptoms, is not an exclusion criterion.
- Current use of anabolic drugs (e.g., testosterone); current use of Erythropoietin; current use of systemic corticosteroid agents (except local administration route, like eye drops or dermatologic formulations).
The study team makes the final eligibility decision.
Where it's taking place
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.