At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 67 enrolled
Drug / intervention
Natalizumab +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Natalizumab and Placebo for Epilepsy, Focal Seizures, Partial Seizures. Completed, enrolled 67 participants across 31 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedSep 2017
Enrollment StartMar 2018
Primary CompletionJan 2020
Study CompletionNov 2020
TodayJul 2026
First PostedSep 14, 2017
Enrollment StartMar 20, 2018
Primary CompletionJan 11, 2020
Study CompletionNov 18, 2020
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 8.8 years ago
Interventions
Natalizumabdrug
As specified in the treatment arm.
Placeboother
As specified in treatment arms.