Phase 2 Efficacy, Safety, and Tolerability Study of Natalizumab in Focal Epilepsy

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.

Timeline

Start

2018-03-20

Primary completion

2020-01-11

Completion

2020-11-18

Outcome

Missed primary endpoint

paper Although the threshold to demonstrate efficacy was not met PMID 34521687 ↗

paper Estimated relative change in seizure frequency of natalizumab over placebo was -14.4% (95% confidence interval [CI] -46.1%-36.1%; p = 0.51). PMID 34521687 ↗

Publications

• French JA, Cole AJ, Faught E, Theodore WH, Vezzani A, Liow K, Halford JJ, Armstrong R, Szaflarski JP, Hubbard S, Patel J, Chen K, Feng W, Rizzo M, Elkins J, Knafler G, Parkerson KA; OPUS Study Group. Safety and Efficacy of Natalizumab as Adjunctive Therapy for People With Drug-Resistant Epilepsy: A Phase 2 Study. Neurology. 2021 Nov 2;97(18):e1757-e1767. doi: 10.1212/WNL.0000000000012766. Epub 2021 Sep 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	natalizumab	Monoclonal antibody	300 mg	Intravenous

Indications