Phase 3
Completed N=710
A Study With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Perampanel (E2007) Administered as an Adjunctive Therapy in Subjects With Refractory Partial-onset Seizures
Source: ClinicalTrials.gov NCT01618695 ↗Enrolled (actual)
710
Serious AEs
10.7%
Results posted
Jun 2020
Primary outcomePrimary: Core Phase: Percent Change in Seizure Frequency (For All Partial Seizures) Per 28 Days in the Randomization Phase Relative to Pre-randomization Phase (Baseline) — -10.76; -17.32; -28.95; -38.03 percent change — p=0.2330
◆ Published Evidence
Established
82citations · ~10 / year
Adjunctive perampanel in partial-onset seizures: Asia-Pacific, randomized phase III study.
Summary
The purpose of this study is to confirm the efficacy and safety of perampanel compared to placebo in patients with refractory partial-onset seizures
Linked Publications (2)
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Adjunctive perampanel in partial-onset seizures: Asia-Pacific, randomized phase III study.
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Perampanel add-on for drug-resistant focal epilepsy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Core Phase: Percent Change in Seizure Frequency (For All Partial Seizures) Per 28 Days in the Randomization Phase Relative to Pre-randomization Phase (Baseline) |
-10.76; -17.32; -28.95; -38.03 | 0.2330 |
| SECONDARY Core Phase: Responder Rate During the Maintenance Period of the Randomization Phase Relative to the Prerandomization Phase (Baseline)- Last Observation Carried Forward (LOCF) |
19.4; 23.0; 36.0; 43.3 | 0.3954 |
| SECONDARY Core Phase: Percent Change in Seizure Frequency Per 28 Days For Complex Partial Seizures Plus Secondary Generalized Seizures in the Randomization Phase Relative to the Prerandomization Phase (Baseline) |
-11.70; -19.08; -33.68; -41.80 | 0.0552 |
| SECONDARY Core Phase: Number of Participants With Clinical Global Impression of Change (CGIC) Scores |
3; 5; 11; 9; 31; 39 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female and greater than or equal to 12 years of age;
- Have a diagnosis of epilepsy with partial seizures with or without secondarily generalized seizures
- Participants with computed tomography (CT) or magnetic resonance imaging (MRI) diagnosis within the last 10 years (for adults) and 5 years (for adolescents) prior to visit 1 that ruled out progressive central nervous system (CNS) disorders, example, neurodegenerative disorders, brain tumors. For participants without existing CT or MRI results, CT or MRI was performed at or after Visit 1 but results evaluation was performed by Visit 2
- Participants who had been treated for at least 12 weeks but confirmed to be uncontrolled with more than one standard antiepileptic drug (AED) for 2 years before enrollment
- During the 6-week Prerandomization Phase participants must have had greater than or equal to 5 partial seizures per 6-week
- Are currently being treated with stable doses and administrations of 1, 2, or a maximum of 3 approved AEDs. Only 1 inducer AED (defined as carbamazepine, phenytoin or oxcarbazepine only) out of the maximum of 3 AEDs is allowed
Exclusion Criteria
- Presence of nonmotor simple partial seizures only;
- Presence of primary generalized epilepsies or seizures, such as absences and/or myoclonic epilepsies;
- Presence or previous history of Lennox-Gastaut syndrome;
- A history of status epilepticus within 1 year prior to screening
- Seizure clusters where individual seizures cannot be counted
- A history of psychogenic seizures within 5 years prior to screening
Data sourced from ClinicalTrials.gov (NCT01618695) and the linked publication. 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.