Phase 2 Efficacy, Safety, and Tolerability Study of Natalizumab in 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.
- Epilepsy, Focal Seizures, Partial Seizures
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Genders
- Accepts Healthy Volunteers
- 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
- 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
- Phase 2
- Study Type
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- 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 placebo-controlled phase is followed by a 6-month open-label phase during which all subjects receive natalizumab.
- Primary Purpose
- Triple (Participant, Investigator, Outcomes Assessor)
- Masking Description
Natalizumab 300 mg
|Participants will undergo a prospective baseline period of 6 weeks (Weeks -6 to 0) followed by placebo controlled phase to receive natalizumab 300 mg intravenous (IV) infusion every 4 weeks from Week 0 to Week 24. Participants will continue to receive natalizumab 300 mg IV infusion every 4 weeks for up to an additional 24 weeks in open label phase.||
|Participants will undergo a prospective baseline period of 6 weeks (Weeks -6 to 0) followed by placebo controlled phase to receive natalizumab matching placebo intravenous (IV) infusion every 4 weeks from Week 0 to Week 24. Participants will then receive natalizumab 300 mg IV infusion every 4 weeks for 24 weeks in open label phase.||
- Active, not recruiting