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Phase 2 Efficacy, Safety, and Tolerability Study of Natalizumab in Focal Epilepsy | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

NCT03283371•Biogen

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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

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.

Locations (31)

Research Site

Birmingham, Alabama, United States

Research Site

Phoenix, Arizona, United States

Research Site

Phoenix, Arizona, United States

Research Site

San Diego, California, United States

Research Site

Santa Monica, California, United States

Research Site

Washington D.C., District of Columbia, United States

Research Site

Jacksonville, Florida, United States

Research Site

Maitland, Florida, United States

Research Site

Orlando, Florida, United States

Research Site

Tallahassee, Florida, United States

Key Dates

Start Date

March 20, 2018

Primary Completion Date

January 11, 2020

Completion Date

November 18, 2020

Last Updated

December 14, 2021

Enrollment

ACTUAL participants

Conditions

Epilepsy, Focal Seizures, Partial Seizures

Interventions

Natalizumab

DRUG

Placebo

OTHER