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A Double-blind, Placebo-controlled, Randomized INTerventional Clinical Trial (SARA-INT)

NCT03452488 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 233

Last updated 2024-10-01

Study results available
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Summary

The main objective of the study is to evaluate the effect of two daily doses of BIO101 versus placebo on mobility function as measured by gait speed using the 400MW test. The absolute change from baseline in meters/second observed in each treatment group at 6 Month was compared to the placebo group. Due to the Covid pandemic \>50% of data at endpoint was missing, which may have affected the ability of the study to deliver the expected results. Additionally, although the planned duration of treatment was 6 months, it was extended up to 9 months for some participants as a result of the pandemic.

Conditions

  • Sarcopenia
  • Gait Disorders in Old Age
  • Muscle Weakness

Interventions

DRUG

BIO101

Oral capsules

DRUG

Placebo

Oral capsules

Sponsors & Collaborators

  • Biophytis

    lead INDUSTRY

Principal Investigators

  • Rob Van Maanen · Biophytis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-07
Primary Completion
2020-04-26
Completion
2020-04-26
FDA Drug
Yes

Countries

  • United States
  • Belgium

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03452488 on ClinicalTrials.gov