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Extension Study of Drisapersen in DMD Subjects

NCT02636686 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2018-01-24

No results posted yet for this study

Summary

This is a phase IIIb, multi-centre, open-label extension study in male subjects with DMD who previously have been treated with drisapersen, aiming at assessing the safety and efficacy of drisapersen.

Conditions

Interventions

DRUG

Drisapersen

Subjects will receive 6 mg/kg of drisapersen by subcutaneous injection once weekly. If subjects have experienced an intolerable injection site reaction(s), in consultation with the investigator, the subject may be allowed intermittent injections (8 weeks on/4 weeks off) or weekly intravenous infusions of 3 or 6 mg/kg

Sponsors & Collaborators

Principal Investigators

  • Derry Ridgway, MD · BioMarin Pharmaceutical

Eligibility

Min Age
5 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Bulgaria
  • Czechia
  • France
  • Germany
  • Israel
  • Italy
  • Japan
  • Netherlands
  • Norway
  • Poland
  • Russia
  • South Korea
  • Spain
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT02636686 on ClinicalTrials.gov