Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT01871233
Study type Expanded Access
Source Eisai Inc.
Contact
Status No longer available
Phase

See also
  Status Clinical Trial Phase
Completed NCT01710657 - A Trial to Evaluate the Efficacy and Safety of Adjunctive Therapy With Lacosamide in Adults With Partial-Onset Seizures Phase 3
Completed NCT00975715 - Efficacy, Safety and Tolerability of TRI476 (Oxcarbazepine) in Children With Inadequately Controlled Partial Onset Seizures Phase 2/Phase 3
Completed NCT02072824 - A Safety, Efficacy, and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric Subjects <4 Years of Age With Partial Onset Seizures. Phase 3
Completed NCT01830868 - A Post-marketing Observational Study Of The Use Of Zonisamide (ZNS) in the Adjunctive Treatment Of Adult Patients With Partial Onset Seizures (Study E2090-E044-410) (ZOOM)
Completed NCT03201900 - Study for Verification of Efficacy and Safety for Perampanel Monotherapy in Untreated Participants With Partial Onset Seizures (Including Secondarily Generalized Seizures (FREEDOM Study) Phase 3
Completed NCT01338805 - Phase II BGG492 Capsule Extension for Partial Epilepsy Phase 2
Completed NCT01147003 - Efficacy and Safety of BGG492 as Adjunctive Treatment in Patients With Partial Onset Seizures Phase 2
Completed NCT01407523 - An Open Label Study of L059 Intravenous (IV) in Japanese Epilepsy Subjects With Partial Onset Seizures Phase 2
Completed NCT04252846 - A Study to Investigate Dosage, Effectiveness, and Safety of Perampanel When Used as First Add-on Therapy in Participants >=12 Years With Partial Onset Seizures With or Without Secondary Generalization or With Primary Generalized Tonic-Clonic Seizures Associated With Idiopathic Generalized Epilepsy
Completed NCT01051193 - Long-term Safety and Tolerability of TRI476 (Oxcarbazepine) in Children With Inadequately Controlled Partial Onset Seizures Phase 2/Phase 3
Completed NCT03836924 - A Study to Assess Safety and Efficacy of Perampanel in Indian Participants as an Adjunctive Treatment in Partial Onset Seizures With or Without Secondary Generalized Seizures in Participants With Epilepsy Aged 12 Years or Older
Completed NCT01506882 - An Open Label Study of Levetiracetam Monotherapy in Patients With Newly Diagnosed Focal Epilepsy Phase 3
Completed NCT03288129 - Study to Evaluate the Efficacy and Safety of Perampanel as Monotherapy or First Adjunctive Therapy in Subjects With Partial Onset Seizures With or Without Secondarily Generalized Seizures or With Primary Generalized Tonic-Clonic Seizures Phase 4
Withdrawn NCT01167335 - Evaluate the Efficacy of BGG492 as Adjunctive Treatment in Patients With Refractory Partial Onset Seizures Phase 2
Completed NCT01830400 - A Post-marketing Study Evaluating Eslicarbazepine Acetate (ESL) as Adjunctive Treatment in Partial-Onset Seizures (Study E2093-E044-404) (EPOS) N/A
Completed NCT00655486 - Study to Assess the Long-term Safety of Oral Lacosamide in Subjects With Partial-onset Seizures Phase 3
Completed NCT00655551 - Safety of Intravenous Lacosamide Dose Followed by Twice Daily Oral Lacosamide in Subjects With Partial-onset Seizures Phase 3