Trials / Completed
CompletedNCT03283371
Phase 2 Efficacy, Safety, and Tolerability Study of Natalizumab in Focal Epilepsy
A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study Exploring the Efficacy, Safety, and Tolerability of Natalizumab (BG00002) as Adjunctive Therapy in Adult Subjects With Drug-Resistant Focal Epilepsy
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 67 (actual)
- Sponsor
- Biogen · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Natalizumab | As specified in the treatment arm. |
| OTHER | Placebo | As specified in treatment arms. |
Timeline
- Start date
- 2018-03-20
- Primary completion
- 2020-01-11
- Completion
- 2020-11-18
- First posted
- 2017-09-14
- Last updated
- 2021-12-14
- Results posted
- 2021-04-27
Locations
31 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03283371. Inclusion in this directory is not an endorsement.