Phase 2
Completed N=21
A Long-term Extension Study of E2007 in Patients With Refractory Partial Seizures Uncontrolled With Other Anti-Epileptic Drugs (AEDs)
Refractory Partial Seizures
Source: ClinicalTrials.gov NCT00903786 ↗
Enrolled (actual)
21
Serious AEs
23.8%
Results posted
Aug 2018
Primary outcomePrimary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Perampanel — 21; 11; 5; 2 Participants
Summary
The purpose of this trial is to investigate the safety and tolerability of perampanel in long- term treatment in the patients with refractory partial epilepsy (uncontrolled with other anti-epileptic drugs) who completed Week 10 of Phase II Study E2007-J081-231 study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Perampanel |
21; 11; 5; 2 | — |
| SECONDARY Percent Change in Total Seizure Frequency Per 28 Days for the Treatment Period Summarized Until Week 316 |
-33.33; -36.36; -26.32; -36.67; -31.10; -49.36 | — |
| SECONDARY Responder Rate During the Treatment Period-LOCF |
42.9; 57.1; 42.9; 57.1; 28.6; 71.4 | — |
| SECONDARY The Patient Global Impression of Change (PGIC) at Week 52 and End of Treatment |
17.6; 17.6; 52.9; 11.8; 0.0; 0.0 | — |
| SECONDARY The Clinical Global Impression of Change (CGIC) at Week 52 and End of Treatment |
11.8; 5.9; 64.7; 17.6; 0.0; 0.0 | — |
Eligibility Criteria
Inclusion criteria
- Patients who consent to the study entry on their free will before starting any trial-related activities.
- Patients who participated in Study 231 and completed the required evaluation period (10 weeks).
- Patients who are certainly and voluntarily able to participate in this study and record their seizures by themselves or have family members or caregivers (or nurses, if hospitalized) record the seizures. Patients who wish to continue perampanel treatment and necessitate receiving the long- term administration judged by the investigator or sub-investigator.
Exclusion criteria
- Pregnant or lactating women, women of child-bearing potential, women willing to become pregnant.
- Patients who are ineligible judged by the investigator or sub investigator in light of medical history or complication at enrollment in treatment period.
- Patients who operate heavy equipment or drive should not be recruited into the study.
- Patients who are ineligible for study entry judged by the investigator or sub-investigator.
Data sourced from ClinicalTrials.gov (NCT00903786). 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.