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Study of ACE-031 in Subjects With Duchenne Muscular Dystrophy

NCT01099761 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2022-10-13

Study results available
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Summary

The purpose of this study is to determine if ACE-031 is safe and well-tolerated in boys with Duchenne Muscular Dystrophy (DMD) and to select the optimal doses of ACE-031 in terms of safety and pharmacodynamic (PD) activity for designing future studies. \[Note: This study was terminated based on safety data\]

Conditions

Interventions

BIOLOGICAL

ACE-031 0.5 mg/kg q4wk

ACE-031 0.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.

BIOLOGICAL

ACE-031 1.0 mg/kg q2wk

ACE-031 1.0 mg/kg subcutaneously once every 2 weeks for 12 weeks.

OTHER

Placebo

Matching volume placebo subcutaneously every 2 or 4 weeks for 12 weeks.

Sponsors & Collaborators

  • Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • Canada

Study Locations

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Entities

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 NCT01099761 on ClinicalTrials.gov