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Clinical Trials/EUCTR2016-005023-92-Outside-EU/EEA
EUCTR2016-005023-92-Outside-EU/EEA
Active, not recruiting
Phase 1

An Open-Label, Multi-Center Study to Evaluate the Safety, Efficacy and Tolerability of Eteplirsen in Early Stage Duchenne Muscular Dystrophy

Sarepta Therapeutics, Inc.0 sites40 target enrollmentMarch 28, 2017
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DrugsEXONDYS 51™

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Sarepta Therapeutics, Inc.
Enrollment
40
Status
Active, not recruiting
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 28, 2017
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Male

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. Male 4\-6 years of age
  • •2\. Diagnosis of DMD, genotypically confirmed
  • •3\. Stable dose of oral corticosteroids for at least 12 weeks or has not received corticosteroids for at least 12 weeks
  • •4\. Intact right and left biceps muscles or two alternative upper arm muscle groups
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 40
  • •F.1\.2 Adults (18\-64 years) no
  • •F.1\.2\.1 Number of subjects for this age range
  • •F.1\.3 Elderly (\>\=65 years) no
  • •F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

  • •1\. Use of any pharmacologic treatment (other than corticosteroids) within 12 weeks that may have an effect on muscle strength or function (e.g., growth hormone, anabolic steroids)
  • •2\. Previous or current treatment with any other experimental treatments within 12 weeks or participation in any other clinical trial within 6 months
  • •3\. Major surgery within 3 months prior to the first dose of study drug, or planned surgery during this study which would interfere with the ability to perform study activities
  • •4\. Presence of other clinically significant illness

Outcomes

Primary Outcomes

Not specified

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