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Clinical Trials/EUCTR2009-013762-63-IT
EUCTR2009-013762-63-IT
Active, not recruiting
Not Applicable

A phase I/IIa, open label, escalating dose, pilot study to assess the effect, safety, tolerability and pharmacokinetics of multiple subcutaneous doses of PRO044 in patients with Duchenne muscular dystrophy - ND

PROSENSA THERAPEUTICS BV0 sites18 target enrollmentStarted: April 27, 2010Last updated:
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Overview

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
18
OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
Male

Inclusion Criteria

  • •1\. Age at least 5 and not older than 16 years on the day of first drug administration 2\. Duchenne muscular dystrophy resulting from a mutation correctable by treatment with PRO044 3\. Life expectancy at least 6 months after inclusion in the trial
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range:
  • •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\. Ventilator dependency 2\. Previous treatment with investigational medicinal treatment within 6 months prior to the start of the pre\-screening of the study 3\. Previous treatment with idebenone within 6 months prior to the start of the pre\-screening for the study

Investigators

Similar Trials

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