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



Status:Recruiting
Conditions:Neurology, Neurology, Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 75
Updated:1/23/2019
Start Date:March 20, 2018
End Date:July 17, 2020
Contact:US Biogen Clinical Trial Center
Email:clinicaltrials@biogen.com
Phone:866-633-4636

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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

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.


Key Inclusion Criteria:

- Must have focal epilepsy diagnosed on clinical grounds and as applicable supported by
electroencephalogram findings [Scheffer 2017] and brain imaging. Participants with
multifocal epilepsy may be included if all other entry criteria are met.

- Must have a drug-resistant epilepsy defined as failure of adequate trials of 2 (or
more) tolerated and appropriately chosen and used AEDs (whether as monotherapies or in
combination) [Kwan 2010].

- Experiences 6 or more seizures during the 6-week prospective baseline period and is
not seizure free for more than 21 consecutive days during the prospective baseline
period

Key Exclusion Criteria:

- Focal aware seizures without motor signs are the only seizure type.

- Diagnosis of generalized, combined generalized and focal, or unknown epilepsy

- Known progressive structural CNS lesion.

- History of seizures occurring in predominantly clustered patterns, as determined by
the Investigator, over the 12 months prior to the Screening Visit (Week -6) or during
the 6-week prospective baseline period, where individual seizures cannot be counted.

- History of status epilepticus within the previous 6 months.

- Known history or presence of non-epileptic seizures.

NOTE; Other protocol defined Inclusion/Exclusion criteria may apply
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