Study of ACE-031 in Subjects With Duchenne Muscular Dystrophy

http://clinicaltrials.gov/ct2/show/NCT01099761?term=duchenne&re...

 

Study of ACE-031 in Subjects With Duchenne Muscular Dystrophy
This study is currently recruiting participants.
Verified by Acceleron Pharma, Inc., April 2010
 
Further study details as provided by Acceleron Pharma, Inc.:

Primary Outcome Measures:
  • Safety and tolerability by monitoring adverse events, clinical laboratory tests, electrocardiogram (ECG), echocardiogram (ECHO), physical examinations, vital signs, and anti-drug antibodies [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Percent change from baseline in total body lean mass by DXA [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in timed function tests [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change from baseline in muscle strength tests [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change from baseline in pulmonary function tests [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 76
Study Start Date: April 2010
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Eligibility

Ages Eligible for Study:   4 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of DMD confirmed
  • Ambulant
  • Corticosteroid therapy for at least one year prior to study day 1 and on a stable dose and schedule for at least 6 months prior to study day 1
  • Evidence of muscle weakness by clinical assessment

Exclusion Criteria:

  • Any previous treatment with another investigational product within 6 months prior to study day 1
  • Any clinically significant cardiac, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease that is not related to DMD
  • Inability to perform a whole body dual x-ray absorptiometry (DXA) scan

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01099761

Contacts
Contact: Trial Manager clinicaltrials@acceleronpharma.com

Locations
Canada, Ontario
Acceleron Investigative Site Recruiting
London, Ontario, Canada
 
 

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Thanks for posting this. Do you know if they are recruiting US patients?
I have no idea. I would email and ask.

Contacts
Contact: Trial Manager clinicaltrials@acceleronpharma.com
I just did. Thanks. Will post the response as soon as I get it.

Thanks again. I have been looking for this.
WOW, they respond immediately! They are looking into regulations to see if they can accept US patients.
That is GREAT! Thanks for posting.

Bains said:
WOW, they respond immediately! They are looking into regulations to see if they can accept US patients.

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