Trials / Completed
CompletedNCT02657915
Long-Term Assessment of Remyelinating Therapy
A Multicenter, Follow-Up Study to Assess Long-Term Electrophysiologic and Clinical Outcomes in Subjects Previously Enrolled in Study 215ON201
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 52 (actual)
- Sponsor
- Biogen · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of the study is to assess full-field visual evoked potential (FF-VEP) latency in subjects who were enrolled in Study NCT01721161 2 years (+ up to 12 months) after the last study visit. The secondary objective is to assess clinical progression and severity of central nervous system (CNS) demyelinating disease in subjects who were enrolled in Study NCT01721161 2 years (+ up to 12 months) after the last study visit. Intervention was administered in the previous study. The participants, investigator and outcome assessors remain blinded in this follow-up study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo | Administered as specified in the treatment arm. |
| DRUG | BIIB033 100mg/Kg | Administered as specified in the treatment arm. |
Timeline
- Start date
- 2016-03-10
- Primary completion
- 2017-01-23
- Completion
- 2017-01-23
- First posted
- 2016-01-18
- Last updated
- 2019-09-23
- Results posted
- 2019-09-23
Locations
23 sites across 11 countries: Australia, Belgium, Canada, Czechia, Denmark, Germany, Hungary, Italy, Spain, Sweden, United Kingdom
Source: ClinicalTrials.gov record NCT02657915. Inclusion in this directory is not an endorsement.