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20-HYDROXYECDYSONE

Clinical trials are studying 20-HYDROXYECDYSONE in older adults with sarcopenia, a condition marked by loss of muscle strength and function. The main goal is to evaluate efficacy and safety, including whether it can help delay major mobility disability. The trial data focus on non-disabled elderly patients with severe sarcopenia.

Table of contents

Trial overview

The available trial data describe one study of 20-HYDROXYECDYSONE in older adults with sarcopenia, which is a condition linked to loss of muscle strength and function.[1]

The study is titled SARA-31 and is designed to evaluate the efficacy and safety of BIO-101 in elderly patients with severe sarcopenia.[1]

The brief summary says the study compares BIO101 350 mg twice daily by mouth with placebo in non-disabled older patients with sarcopenia.[1]

Who is being studied

The target population is elderly patients who have severe sarcopenia and are still non-disabled at the start of the study.[1]

This means the trial is focused on older people who may still move and function on their own, but who have a muscle condition that may put them at risk for later mobility problems.[1]

Study design and phase

This is an interventional study, which means researchers are giving a treatment and then measuring the results.[1]

The trial is described as randomized, double-blind, and placebo-controlled.[1]

Randomized means participants are assigned by chance to a study group, double-blind means neither the participant nor the study team knows who gets which treatment, and placebo-controlled means one group receives an inactive comparison treatment.[1]

The study phase is Phase 3, which is a later stage of clinical research usually used to test whether a treatment works in a larger group and to collect more safety information.[1]

What the trial measures

The main outcome is time to onset of Major Mobility Disability (MMD).[1]

In simple terms, this means the study is checking how long it takes before a participant develops serious trouble with movement or walking.[1]

The brief summary also states that the study is designed to evaluate the hazard of major mobility disability, which means the researchers are looking at the risk over time.[1]

Treatment groups

The trial includes a placebo group and a 20-HYDROXYECDYSONE-related study treatment group listed in the source as BIO-101.[1]

The intervention list names 20-hydroxyecdysone as an oral treatment and also lists placebo hard capsules for comparison.[1]

The source data do not provide additional details about dosing beyond the listed oral use and the brief summary statement.[1]

Trial status and size

The trial status is Authorised, which means it has been approved to proceed in the listed setting.[1]

The planned enrollment is 932 participants, showing that this is a large study for the condition being investigated.[1]

Based on the available data, this is the only listed clinical trial for 20-HYDROXYECDYSONE in the provided source.[1]

Trial ID Phase Condition studied Status Enrollment
2022-502417-28-01 Phase 3 Sarcopenia Authorised 932

FAQ

  • What is being studied in the 20-HYDROXYECDYSONE trial? The trial is studying 20-HYDROXYECDYSONE as part of a treatment strategy for sarcopenia in older adults. It compares the study drug with placebo, which is an inactive treatment.
  • Who can take part in this trial? The trial is for elderly, non-disabled patients who have severe sarcopenia. The source data do not give more details about age limits or other entry rules.
  • What phase is the trial? This is a Phase 3 trial. Phase 3 studies usually involve larger groups of people and look closely at how well a treatment works and how safe it is.
  • What condition is the trial focused on? The trial is focused on sarcopenia. This means loss of muscle strength and muscle function, which can affect movement and daily life.
  • What outcome is the trial measuring? The main outcome is time to onset of major mobility disability. This means how long it takes before a person has serious trouble moving around.

Ongoing Clinical Trials on 20-HYDROXYECDYSONE

  • Evaluation of BIO-101 versus placebo for treating severe sarcopenia in elderly patients with reduced mobility

    Not yet recruiting

    1 1
    Investigated drugs:
    Belgium

Glossary

  • Sarcopenia: A condition in which a person loses muscle strength and muscle function, often seen in older adults.
  • Severe sarcopenia: A more serious form of sarcopenia with greater loss of muscle strength and function.
  • Older adults: Elderly people who are the main population studied in this trial.
  • Non-disabled: People who can still function without major disability at the start of the study.
  • Interventional trial: A study in which researchers give a treatment and observe the results.
  • Randomized: Participants are assigned by chance to different study groups.
  • Double-blind: Neither the participant nor the study team knows which treatment is given, which helps reduce bias.
  • Placebo: An inactive treatment used for comparison in a study.
  • Phase 3: A later stage of clinical research that usually studies many participants to check benefit and safety.
  • Major mobility disability: A serious problem with walking or moving around.
  • Primary outcome: The main result the study is designed to measure.

References

  1. https://clinicaltrials.gov/study/2022-502417-28-01