Status:
COMPLETED
Phase 2 Efficacy, Safety, and Tolerability Study of Natalizumab in Focal Epilepsy
Lead Sponsor:
Biogen
Conditions:
Epilepsy, Focal Seizures, Partial Seizures
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
March 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 18 2020
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT03283371
Start Date
March 20 2018
End Date
November 18 2020
Last Update
December 14 2021
Active Locations (31)
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1
Research Site
Birmingham, Alabama, United States, 35294
2
Research Site
Phoenix, Arizona, United States, 85004
3
Research Site
Phoenix, Arizona, United States, 85054
4
Research Site
San Diego, California, United States, 92103