Phase 2
N=67
Phase 2 Efficacy, Safety, and Tolerability Study of Natalizumab in Focal Epilepsy
Epilepsy, Focal Seizures, Partial Seizures
Bottom Line
View on ClinicalTrials.gov: NCT03283371 ↗Enrolled (actual)
67
Serious AEs
5.5%
Results posted
Apr 2021
Primary outcome: Primary: Change From Baseline in Log-Transformed Seizure Frequency During Weeks 8 to 24 of Treatment — -0.43; -0.58 log(seizure/28 days) — p=0.5053
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Natalizumab (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Biogen
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Log-Transformed Seizure Frequency During Weeks 8 to 24 of Treatment |
-0.43; -0.58 | 0.5053 |
| SECONDARY Percentage of Responders During Weeks 8 to 24 of Treatment |
17.6; 31.3 | 0.2231 |
| SECONDARY Number of Participants Free From Seizures During Weeks 8 to 24 of Treatment |
1; 0 | — |
| SECONDARY Percent Change From Baseline of Seizure-Free Days Change During Weeks 8 to 24 of Treatment |
16.23; 17.54; 4.33; 39.23; 2.41; 32.59 | — |
| SECONDARY Percentage of Participants With Inadequate Treatment Response During Weeks 8 to 24 of Treatment |
6; 3 | 0.6854 |
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 Criteria
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
Data sourced from ClinicalTrials.gov (NCT03283371). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.