Partial Onset Seizures Clinical Trial
Official title:
An Extended Access Program for Perampanel
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.
n/a
| 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 |