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NCT01871233
An Extended Access Program for Perampanel
trial testing Perampanel in Partial Onset Seizures. No longer available.
Quick facts
| Lead sponsor | Eisai Inc. |
|---|---|
| Status | NO LONGER AVAILABLE |
| Study type | EXPANDED_ACCESS |
| Sites | 78 locations across Hong Kong, Italy, Finland, Malaysia, Taiwan, Poland, Netherlands, Belgium |
Drugs / interventions tested
- Perampanel (PERAMPANEL) — full drug profile →
Conditions studied
- Partial Onset Seizures — all drugs for Partial Onset Seizures →
Sponsor
Eisai Inc. — full company profile →
Who can join
Adults 12 to 70, any sex, with Partial Onset Seizures. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The Extended Access Program (EAP) is a managed access programme for Perampanel. The main objective of this EAP is to ensure that patients participating in studies E2007-A001-207, E2007-G000-307, or E2007-G000-235 continue to have access to perampanel until such time perampanel tablets become commercially available for the treatment of Partial Onset Seizures (POS) in the country in which they reside. This EAP will consist of 2 phases: * Screening: The patient will start the program once the Screening assessments are completed and the patient is qualified for participation. * Treatment: Additional assessments, physical examinations, and dosage changes will be clinically determined by the treating physician. Patients will enter this program on the same dose of perampanel that they were receiving at the end of their participation in previous study. Doses of perampanel and of concomitant anti-epileptic drugs (AEDs) can be adjusted (i.e., added,removed, or changed in dose) based on clinical judgment. Treatment will be prescribed as long as clinically appropriate according to the judgement of the treating physician and the approved Summary of Product Characteristics (SmPC). The program will complete in a staggered fashion, country by country, as and when perampanel becomes commercially available for the treatment of POS in each country.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Perampanel and pregnancy.
Vazquez B, Tomson T, Dobrinsky C, Schuck E, et al · · 2021 · cited 29× · PMID 33666943 · DOI 10.1111/epi.16821
Verify or expand the search:
- PubMed search for NCT01871233
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Perampanel
Trials testing the same drug.
- NCT07284069 — Senicapoc and Perampanel for Newly Diagnosed Glioblastoma · EARLY_PHASE1 · recruiting
- NCT05684978 — Efficacy and Safety of Perampanel in the Treatment of Refractory Status Epilepticus · Phase 4 · terminated
- NCT06401707 — PeRampanel fOr Status ePilEpticus pRophylaxis Post-cardiac Arrest · Phase 2 · recruiting
- NCT04309721 — Perampanel in Focal Status Epilepticus · Phase 3 · terminated
- NCT05533814 — A Study to Evaluate the Efficacy and Safety of Perampanel Monotherapy in Untreated Participants With Focal Onset Seizure · Phase 4 · completed
Other Eisai Inc. trials
Trials by the same sponsor.
- NCT07493265 — A Study to Evaluate the Efficacy and Safety of E2086 in Adults With Narcolepsy · Phase 2 · not yet recruiting
- NCT07308236 — A Study to Determine the Metabolism and Excretion of [14C]E2086 in Healthy Male Participants · Phase 1 · recruiting
- NCT06854042 — A Study of Oral E1018 in Healthy Adult Participants · Phase 1 · recruiting
- NCT06744673 — A Study to Assess the Pregnancy Outcome in Women Exposed to Dayvigo® During Pregnancy Compared to an Unexposed Control P · active not recruiting
- NCT06602258 — A Study of E2814 With Concurrent Lecanemab Treatment in Participants With Early Alzheimer's Disease · Phase 2 · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01871233 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Eisai Inc.
- Last refreshed: 16 April 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01871233.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing