Extension Study of ACE-031 in Subjects With Duchenne Muscular Dystrophy

NCTNCT01239758Other idA031-06

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: This study was terminated based on preliminary safety data.

Overview

Status: Terminated
Phase: Phase 2
Enrollment: 11 participants (actual)
Sponsor: Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA · Industry
Design: Not randomized · Open label (no masking)
Countries: 1 country
Canada
Start: Oct 2010
Primary completion: May 2011
Completion: May 2011
First posted: 11 Nov 2010 (estimated)
Last update posted: 1 Feb 2013 (estimated)
Conditions: Duchenne Muscular Dystrophy

Timeline

1 trial · 1 stopped early

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201020112012

Ph 2
Extension Study of ACE-031 in Subjects With Duchenne Muscular Dystrophy
NCT01239758
Oct 2010 to May 2011
Terminated
Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

To evaluate the long-term safety and tolerability of ACE-031 administration in subjects with Duchenne muscular dystrophy (DMD) who participated in Study A031-03. \[Note: This study was terminated based on preliminary safety data. Pending further analysis of safety data and discussion with health authorities, a new ACE-031 trial will be planned.\]

Interventions

ACE-031 (Extension of cohort 1 from core study, A031-03)Biological
ACE-031 (Extension of cohort 2 from core study, A031-03)Biological
ACE-031 (Extension of cohort 3 from core study, A031-03)Biological

Arms3

Experimental
ACE-031 (Extension of cohort 1 from core study, A031-03)
Experimental
ACE-031 (Extension of cohort 2 from core study, A031-03)
Experimental
ACE-031 (Extension of cohort 3 from core study, A031-03)

Primary outcomes2

Outcomes the sponsor listed as primary.

Number of patients with adverse events.
Time frame · From treatment initiation to End-of-Study Visit, approximately 24 weeks later.
Change in laboratory parameters and vital signs.
Time frame · Baseline to End-of-Study Visit, approximately 24 weeks later.

Secondary outcomes(6)

Percent change in total lean body mass by DXA scan.
Time frame · Baseline to End-of-Study Visit, approximately 24 weeks later.
Percent change in total body and lumbar spine bone mineral density by DXA scan.
Time frame · Baseline to End-of-Study Visit, approximately 24 weeks later.
Percent change in muscle strength score by hand-held myometry.
Time frame · Baseline to End-of-Study Visit, approximately 24 weeks later.
Change in distance traveled in 6 minutes (standardized 6-Minute-Walk Test).
Time frame · Baseline to End-of-Study Visit, approximately 24 weeks later.
Change in time to travel 10 meters (standardized 10-Meter-Walk/Run test).
Time frame · Baseline to End-of-Study Visit, approximately 24 weeks later.
Change in pulmonary function tests.
Time frame · Baseline to End-of-Study Visit, approximately 24 weeks later.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Male
Age: from 4 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Completion of participation in Study A031-03 and Investigator approval * Continuation of corticosteroid therapy at the same absolute dose and schedule as on Study A031-03 Exclusion Criteria: * Participation in any other therapeutic clinical trial * Plans to have surgery during the course of the study

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