Trials / Withdrawn
WithdrawnNCT01890798
Drisapersen Duchenne Muscular Dystrophy (DMD) Treatment Protocol
A Continued Access Protocol for Eligible US Subjects With Duchenne Muscular Dystrophy Who Previously Participated in an Approved Drisapersen Study
- Status
- Withdrawn
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- Male
- Age
- 5 Years
- Healthy volunteers
- Not accepted
Summary
This is a single arm, open-label continued access protocol of drisapersen for the treatment of male subjects with Duchenne muscular dystrophy (DMD) having dystrophin mutations correctable by drisapersen-induced DMD Exon 51 skipping. The purpose of this continued access protocol is to offer pre-approval access to drisapersen for the treatment of subjects with DMD who previously participated in eligible drisapersen studies. The protocol will collect safety data required to assure subject safety and periodic efficacy data on muscle function.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Drisapersen | Drisapersen will be supplied as 3 millilitre (mL) vials containing 1mL sterile solution for subcutaneous injection. The strength of drisapersen solution will be 200 mg/mL. |
Timeline
- Start date
- 2014-01-01
- Primary completion
- 2014-01-01
- Completion
- 2015-07-01
- First posted
- 2013-07-02
- Last updated
- 2014-03-24
Source: ClinicalTrials.gov record NCT01890798. Inclusion in this directory is not an endorsement.