Trials / Completed
CompletedNCT02594124
A Study for Participants With Spinal Muscular Atrophy (SMA) Who Previously Participated in Nusinersen (ISIS 396443) Investigational Studies
An Open-Label Extension Study for Patients With Spinal Muscular Atrophy Who Previously Participated in Investigational Studies of ISIS 396443
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 292 (actual)
- Sponsor
- Biogen · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The primary objective is to evaluate long-term safety and tolerability of nusinersen (ISIS 396443) administered by intrathecal (IT) injection to participants with Spinal Muscular Atrophy (SMA) who previously participated in investigational studies of nusinersen. The secondary objective is to examine the long-term efficacy of nusinersen administered by IT injection to participants with SMA who previously participated in investigational studies of nusinersen.
Detailed description
This study was initiated and the protocol was registered by Ionis Pharmaceuticals, Inc. In August 2016, Biogen assumed responsibility for this study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | nusinersen | Administered by intrathecal (IT) injection |
Timeline
- Start date
- 2015-11-04
- Primary completion
- 2023-08-21
- Completion
- 2023-08-21
- First posted
- 2015-11-02
- Last updated
- 2024-10-22
- Results posted
- 2024-10-22
Locations
47 sites across 14 countries: United States, Australia, Belgium, Canada, France, Germany, Hong Kong, Italy, Japan, South Korea, Spain, Sweden, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02594124. Inclusion in this directory is not an endorsement.