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Follistatin 315

Activin-Binding Protein, FSH-Suppressing Protein, FST-315, FS-315

Quick Stats
Studies 14
Trials 93
Completed PHASE2 INTERVENTIONAL NCT03236662

(-)- Epicatechin Becker Muscular Dystrophy

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

This is a 48-week open-label extension of our initial proof-of-concept study (UCD0113) in patients with Becker muscular dystrophy who participated in the earlier trial. This single center study will enroll up to 10 adults who will receive the purified nutritional extract (-)-epicatechin 100mg/day orally for 8 weeks. After screening visits, participants will be enrolled in the study if they meet all inclusion criteria. They will be evaluated at screening, baseline, and weeks 4, 8, 12, 24, 16 and 48. The main criterion for success of the study will be presence of one or more biologic or strength and performance outcome measures that yield a response magnitude that allows for sufficient power in a Phase II B study with a sample size of 30 individuals.

Interventions

Name: (-)-Epicatechin
Type: DRUG
Description:

Primary Outcomes

Measure: Plasma Follistatin
TimeFrame: 48 weeks
Description: blood biomarker concentration
Measure: Plasma Myostatin
TimeFrame: 48 weeks
Description: blood biomarker concentration
Measure: Plasma Nitrates/ SNO
TimeFrame: 48 weeks
Description: blood biomarker concentration
Measure: Plasma BNP
TimeFrame: 48 weeks
Description: blood biomarker concentration
Measure: Plasma Creatine Kinase
TimeFrame: 48 weeks
Description: blood biomarker concentration
Measure: Plasma MMP-9
TimeFrame: 48 weeks
Description: blood biomarker concentration
Measure: Plasma TNF-Alpha
TimeFrame: 48 weeks
Description: blood biomarker concentration
Measure: Plasma TGF-Beta
TimeFrame: 48 weeks
Description: blood biomarker concentration
Measure: Plasma Follistatin:Myostain Ratio
TimeFrame: 48 weeks
Description: Ratio of plasma follistatin to plasma myostatin

Trial Information

NCT ID

NCT03236662

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE2

Sponsor

Craig McDonald, MD

Last Updated

December 15, 2025

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