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Follistatin 315

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

Quick Stats
Studies 14
Trials 93
Completed PHASE1, PHASE2 INTERVENTIONAL NCT01856868

Use of (-)-Epicatechin in the Treatment of Becker Muscular Dystrophy (Pilot Study)

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

(-)-Epicatechin will be evaluated for the treatment of progressive muscle loss and impaired skeletal muscle function in Becker Muscular Dystrophy (BMD) patients.

Detailed Description

This is a proof-of-concept phase 1/2a pilot and endpoint development study that is designed to provide initial evidence of biological activity of (-)-epicatechin. Primary endpoints include initial assessment of tissue-specific evidence of efficacy from muscle biopsy samples. Secondary endpoints include measures of strength and physical function, and safety and adverse event data. Pilot endpoints include assessment of mRNA and miRNA peripheral blood profiles and validation of non-invasive near-infrared spectroscopy (NIRS) muscle perfusion studies during exercise and a recumbent cycle exercise test that may be employed as endpoints in future clinical trials. This single center open-label pilot study will enroll 10 adults with genetically-confirmed Becker muscular dystrophy, 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 baseline and at screening, day 1, and weeks 1, 2, 4 and 8.

Interventions

Name: (-)-epicatechin
Type: DRUG
Description: purified nutritional extract (-)-epicatechin 100mg/day orally for 8 weeks.

Primary Outcomes

Measure: Change From Baseline in Muscle Tissue PGC1alpha (AU) at 8 Weeks
TimeFrame: Baseline and 8 Weeks
Description: Western blot measurement of the transcriptional coactivator gene PGC1alpha involved in mitochondrial biogenesis will be assessed using relative band intensities of the pre-treatment (Baseline) and post-treatment (8 Weeks) specimens with digitally quantified using ImageJ software.
Measure: Mean Change From Baseline in Muscle Tissue AMPK at 8 Weeks
TimeFrame: 8 weeks
Description: Western blot measurement of AMPK will be assessed using relative band intensities of the pre-treatment and post-treatment specimens with digitally quantified using ImageJ software).
Measure: Mean Change From Baseline in Muscle Tissue LKB1 at 8 Weeks
TimeFrame: 8 weeks
Description: Western blot measurement of LKB1 will be assessed using relative band intensities of the pre-treatment and post-treatment specimens with digitally quantified using ImageJ software) .
Measure: Mean Change From Baseline in Cristae-associated Mitofillin Levels at 8 Weeks
TimeFrame: 8 weeks
Description: Western blot measurement of Mitofillin will be assessed using relative band intensities of the pre-treatment and post-treatment specimens with digitally quantified using ImageJ software.
Measure: Mean Change From Baseline in Muscle Tissue Follistatin at 8 Weeks
TimeFrame: 8 weeks
Description: Regulators of muscle growth and regeneration including follistatin will be assessed by Western using relative band intensities of the pre-treatment and post-treatment specimens with digitally quantified using ImageJ software).
Measure: Mean Change From Baseline in Muscle Tissue Myostatin at 8 Weeks
TimeFrame: 8 weeks
Description: Regulators of muscle growth and regeneration including myostatin will be assessed by Western using relative band intensities of the pre-treatment and post-treatment specimens with digitally quantified using ImageJ software).
Measure: Mean Change From Baseline in Muscle Tissue Myogenin at 8 Weeks
TimeFrame: 8 weeks
Description: Modulators of skeletal muscle regeneration by Western will include myogenin will be assessed using relative band intensities of the pre-treatment and post-treatment specimens with digitally quantified using ImageJ software).
Measure: Mean Change From Baseline in Muscle Tissue Myf5 at 8 Weeks
TimeFrame: 8 weeks
Description: Modulators of skeletal muscle regeneration My5 will be assessed by Western using relative band intensities of the pre-treatment and post-treatment specimens with digitally quantified using ImageJ software).
Measure: Mean Change From Baseline in Muscle Tissue MyoD at 8 Weeks
TimeFrame: 8 weeks
Description: Modulators of skeletal muscle regeneration MyoD will be assessed by Western using relative band intensities of the pre-treatment and post-treatment specimens with digitally quantified using ImageJ software).
Measure: Mean Change From Baseline in Muscle Tissue MEF2a at 8 Weeks
TimeFrame: 8 weeks
Description: Modulators of skeletal muscle regeneration MEF2a will be assessed by Western using relative band intensities of the pre-treatment and post-treatment specimens with digitally quantified using ImageJ software).
Measure: Mean Change From Baseline in Muscle Tissue Dysferlin at 8 Weeks
TimeFrame: 8 weeks
Description: Structure associated indicators including dysferlin will be assessed by Western using relative band intensities of the pre-treatment and post-treatment specimens with digitally quantified using ImageJ software).
Measure: Mean Change From Baseline in Muscle Tissue Utrophin at 8 Weeks
TimeFrame: 8 weeks
Description: Structure associated indicators including utrophin will be assessed by Western using relative band intensities of the pre-treatment and post-treatment specimens with digitally quantified using ImageJ software).

Trial Information

NCT ID

NCT01856868

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE1, PHASE2

Sponsor

Craig McDonald, MD

Last Updated

December 15, 2025

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