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OPUS


Title 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
Therapeutic Area Epilepsy
Principal Investigator Joel Oster, MD
Min Age 18 Years
Max Age 75 Years
Gender Any
Contact Lindsey Soll
617-636-7620
More Information https://www.clinicaltrials.gov/ct2/show/study/NCT03283371

Overview

This is a 6-month randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of natalizumab as adjunctive therapy in the treatment of adult subjects with drug-resistant focal epilepsy. The primary efficacy objective of the study is to determine if adjunctive therapy of natalizumab 300mg 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

Inclusion Criteria

  • Diagnosed with drug-resistant focal epilepsy.
  • Currently on a stable regiment of 1-5 AEDs.
  • On average experience 6 or more seizures during a 6 week baseline.

Exclusion Criteria

  • Diagnosis of generalized, combined generalized and focal, or unknown epilepsy.
  • History of status epilepticus within the last 12 months.
  • History or presence of non-epileptic seizures.

Study Requirements

Number of research visits:15

Length of participation: 60 weeks

Number of blood collections: up to 15

MRI scan within 48 months of enrollment.