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NCT03283371 · ClinicalTrials.gov registry record · Phase 2
Phase 2 Efficacy, Safety, and Tolerability Study of Natalizumab in Focal Epilepsy
A Phase 2 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 2
- Development phase
- 67
- Enrollment target
NCT03283371: Completed Phase 2 study, sponsored by Biogen.
NCT03283371 is a Phase 2 study that has completed, run by Biogen. The registered enrollment target is 67 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03283371, a Phase 2 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 67 participants
- Enrollment target
Study Summary
The primary efficacy objective of the study is to determine if adjunctive therapy of natalizumab 300 mg intravenous (IV) every 4 weeks reduces the frequency of seizures in adult participants with drug-resistant focal epilepsy. The secondary efficacy objective is to assess the effects of natalizumab versus placebo in drug-resistant focal epilepsy on additional measures of seizure frequency.
Primary Outcome
Seizures included were focal aware seizures with motor signs, focal impaired awareness seizures and focal to bilateral tonic-clonic seizure. Focal aware seizures without motor signs were not included. Seizure clusters (where individual seizures cannot be distinguished) were counted as 1 seizure per cluster on each day that they are present. Study baseline seizure frequency (number of seizures per 28 days) was calculated based on participant's seizure diary data during prospective baseline phase.
Interventions
- OTHER Placebo
- DRUG Natalizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2018-03-20 |
| Est. Completion | 2020-11-18 |
| Phase | Phase 2 |
What the finished NCT03283371 record still lists
NCT03283371 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03283371 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03283371 about?
NCT03283371 is a clinical study titled "Phase 2 Efficacy, Safety, and Tolerability Study of Natalizumab in Focal Epilepsy". The primary efficacy objective of the study is to determine if adjunctive therapy of natalizumab 300 mg intravenous (IV) every 4 weeks reduces the frequency of seizures in adult participants with drug-resistant focal epilepsy. The secondary efficacy objective is to assess the effects of natalizumab ...
What is the current status of trial NCT03283371?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 67 participants. The study started on 2018-03-20. Estimated completion is 2020-11-18.
What interventions are being tested in trial NCT03283371?
The interventions under investigation include: Placebo (OTHER), Natalizumab (DRUG).
Who is sponsoring clinical trial NCT03283371?
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 NCT03283371's enrollment target sits among peer trials
67 974th of 2000 higher than 1,026 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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