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NCT02430532 · ClinicalTrials.gov registry record · Phase 3
BG00012 and Delay of Disability Progression in Secondary Progressive Multiple Sclerosis
A Phase 3 study, sponsored by Biogen.
- Terminated
- Registry status
- Phase 3
- Development phase
- 58
- Enrollment target
NCT02430532: Clinical Trial Phase 3 study, sponsored by Biogen.
NCT02430532 is a Phase 3 study that was terminated before completion, run by Biogen. The registered enrollment target is 58 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02430532, a Phase 3 study, was terminated before completion, sponsored by Biogen.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 58 participants
- Enrollment target
Study Summary
The primary objective of the study is to investigate whether treatment with BG00012 (dimethyl fumarate) compared with placebo slows the accumulation of disability not related to relapses in participants with secondary progressive multiple sclerosis (SPMS). The secondary objective of the study is to assess the effect of BG00012 compared with placebo on patient-reported outcomes, brain atrophy, and cognitive function.
Primary Outcome
Time to onset of confirmed progression of disability is defined as 1 or more of the following criteria, confirmed at ≥ 6 months after start of treatment and at Week 108 using 1 or more of the following assessments: Expanded Disability Status Scale (EDSS) score increased from Baseline of ≥ 1 point if baseline EDSS ≤ 5.5, or ≥ 0.5 point if Baseline EDSS ≥ 6.0; Timed 25-Foot Walk (T25FW) ≥ 20% increase from Baseline in the time taken for the 25-foot walk; worsening on the 9-Hole Peg Test (9HPT; ≥ 2
Interventions
- OTHER Placebo
- DRUG dimethyl fumarate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2015-05 |
| Est. Completion | 2016-01 |
| Phase | Phase 3 |
Why NCT02430532 stopped before completion
NCT02430532 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02430532 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02430532 about?
NCT02430532 is a clinical study titled "BG00012 and Delay of Disability Progression in Secondary Progressive Multiple Sclerosis". The primary objective of the study is to investigate whether treatment with BG00012 (dimethyl fumarate) compared with placebo slows the accumulation of disability not related to relapses in participants with secondary progressive multiple sclerosis (SPMS). The secondary objective of the study is to ...
What is the current status of trial NCT02430532?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 58 participants. The study started on 2015-05. Estimated completion is 2016-01.
What interventions are being tested in trial NCT02430532?
The interventions under investigation include: Placebo (OTHER), dimethyl fumarate (DRUG).
Who is sponsoring clinical trial NCT02430532?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02430532's enrollment target sits among peer trials
58 1825th of 2000 higher than 174 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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