Phase 4
Completed N=106
Trial Evaluating the Efficacy and Safety of Perampanel Added to Monotherapy in Participants With Partial Onset Seizures With or Without Secondary Generalization
Source: ClinicalTrials.gov NCT02726074 ↗Enrolled (actual)
106
Serious AEs
7.8%
Results posted
Feb 2020
Primary outcomePrimary: 50 Percent (%) Responder Rate for Partial Onset Seizure With or Without Secondary Generalization — 80.0 percentage of participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This is a multi-center, open-label, single-arm, phase 4 study to evaluate the efficacy of perampanel added to monotherapy for partial onset seizures with or without secondarily generalized seizures (total seizures).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 50 Percent (%) Responder Rate for Partial Onset Seizure With or Without Secondary Generalization |
80.0 | — |
| SECONDARY 75% Responder Rate for Partial Onset Seizure With or Without Secondary Generalization |
71.76 | — |
| SECONDARY 100% Responder Rate (Seizure Free Rate) for Partial Onset Seizure With or Without Secondary Generalization |
47.06 | — |
| SECONDARY Percent Change From Baseline in Partial Onset Seizure Frequency With or Without Secondary Generalization to the Titration and Maintenance Period |
-90.48; -95.02 | — |
| SECONDARY 50% Responder Rate in Secondary Generalized Tonic Clonic (GTC) Seizures |
87.50 | — |
| SECONDARY 75% Responder Rate in Secondary GTC Seizures |
87.50 | — |
| SECONDARY 100% Responder Rate (Seizure Free Rate) in Secondary GTC Seizures |
75.00 | — |
| SECONDARY Percent Change From Baseline in Secondary GTC Seizure Frequency to the Titration and Maintenance Period |
-100.00; -100.00 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
77; 8 | — |
Eligibility Criteria
Inclusion Criteria
- Have a diagnosis of epilepsy with partial onset seizures with or without secondarily generalized seizures according to the International League Against Epilepsy's Classification of Epileptic Seizures (1981)
- Need an initial add-on therapy after failure to control seizures with the first or further monotherapy at the optimal dose and duration
- Despite antiepileptic drug (AED) treatment within the last 8 weeks, participants must have had greater than or equal to 2 partial onset seizures, and the interval between those seizures should be more than 24 hours prior to Visit 1 (Week 0).
- Are currently being treated with stable doses of monotherapy for 8 weeks prior to Visit 1 (Week 0) (Standard AEDs)
- If antidepressants or antianxiety drugs are used, participants must be receiving stable doses and administrations of antidepressants or antianxiety drugs for 8 weeks prior to Visit 1 (Week 0)
Exclusion Criteria
- Females who are pregnant (positive beta-human chorionic gonadotropin (β-hCG test) or breastfeeding
- Presence of previous history of Lennox-Gastaut syndrome
- Presence of nonmotor simple partial seizures only
- Presence of primary generalized epilepsies or seizures such as absences and/or myoclonic epilepsies
- A history of status epilepticus within 12 weeks before Visit 1 (Week 0)
- Participants on antipsychotics or who have psychotic disorder(s) or unstable recurrent affective disorder(s) with a history of attempted suicide within 1 year before Visit 1 (Week 0)
- Presence of a progressive central nervous system (CNS) disease, including degenerative CNS diseases and progressive tumors
- Concomitant use of barbiturates (except for seizure control indication and premedication for electroencephalogram [EEG]) and benzodiazepines (except for seizure control indication) within 8 weeks prior to Visit 1 (Week 0)
- Use of intermittent rescue benzodiazepines (that is, 1 to 2 doses over a 24-hr period considered one-time rescue) 2 or more times in an 8-week period prior to Visit 1 (Week 0)
- Participant who is participating in other intervention clinical trial
Data sourced from ClinicalTrials.gov (NCT02726074). 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. Informational only — not medical advice.