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
NCT04252846 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 191
Last updated 2023-02-09
Summary
The primary purpose of this study is to assess the retention rate of perampanel as a reliable proxy for overall effectiveness and tolerability in participants aged at least 12 years who are prescribed perampanel (for partial onset seizures \[POS\] with or without secondary generalization \[SG\] or for primary generalized tonic-clonic seizures \[PGTCS\] associated with idiopathic generalized epilepsy \[IGE\] as first adjunctive to antiepileptic drug (AED) monotherapy as part of their routine clinical care.
Conditions
- Idiopathic Generalized Epilepsy
- Partial Onset Seizures
- Generalised Tonic-Clonic Seizures
Interventions
- DRUG
-
Perampanel
Perampanel oral tablets or oral suspension.
Sponsors & Collaborators
-
Eisai Limited
lead INDUSTRY
Eligibility
- Min Age
- 12 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-07-20
- Primary Completion
- 2023-01-12
- Completion
- 2023-01-12
- FDA Drug
- Yes
Countries
- Denmark
- France
- Germany
- Italy
- Portugal
- Russia
- Spain
Study Locations
More Related Trials
-
A Efficacy and Safety Study of Adjunctive Perampanel in Primary Generalized Tonic Clonic Seizures
NCT01393743 ·Status: COMPLETED ·Phase: PHASE3
-
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
NCT03836924 ·Status: COMPLETED
-
A Study to Evaluate Efficacy and Safety of Perampanel Administered as an Adjunctive Therapy in Pediatric Participants With Childhood Epilepsy
NCT04015141 ·Status: RECRUITING ·Phase: PHASE2
-
A Study With an Open-label Extension Phase to Evaluate the Effect of Perampanel (E2007) on Cognition, Growth, Safety, Tolerability, and Pharmacokinetics in Adolescents
NCT01161524 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of Perampanel as Add-on Therapy in Adult and Adolescent Participants With Focal Seizures
NCT04257604 ·Status: COMPLETED
-
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
NCT01618695 ·Status: COMPLETED ·Phase: PHASE3
-
Evaluation of the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures
NCT00735397 ·Status: COMPLETED ·Phase: PHASE3
-
An Open-label Extension Study to Evaluate the Safety and Tolerability of Perampanel (E2007) Administered as an Adjunctive Therapy in Epilepsy Subjects
NCT02427607 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate the Safety and Efficacy of Fycompa® (Perampanel) as Add-on Therapy in Participants With Epilepsy
NCT04230044 ·Status: COMPLETED
-
A Study to Evaluate the Effectiveness of Perampanel as Only Add-on Treatment in Participants With Primary or Secondarily Generalized Tonic-clonic Seizures
NCT04202159 ·Status: COMPLETED
-
A Study to Evaluate the Efficacy and Safety of Perampanel Monotherapy in Untreated Participants With Focal Onset Seizures With or Without Focal to Bilateral Tonic-clonic Seizures
NCT05533814 ·Status: COMPLETED ·Phase: PHASE4
-
To Evaluate The Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures
NCT00699582 ·Status: COMPLETED ·Phase: PHASE3
-
Study of Perampanel as Adjunctive Treatment for Inadequately Controlled Seizures Associated With Lennox-Gastaut Syndrome
NCT02834793 ·Status: TERMINATED ·Phase: PHASE3
-
Evaluating the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures
NCT00699972 ·Status: COMPLETED ·Phase: PHASE3
-
Pharmacokinetics, Efficacy, and Safety of Perampanel Oral Suspension on Seizure Frequency in Pediatric Subjects Maintained on One to Three Stable Antiepileptic Drugs
NCT01527006 ·Status: COMPLETED ·Phase: PHASE2
-
Perampanel in Seizure Patients With Primary Glial Brain Tumors
NCT02363933 ·Status: COMPLETED ·Phase: PHASE4
-
Efficacy and Safety of Perampanel in the Treatment of Refractory Status Epilepticus
NCT05684978 ·Status: TERMINATED ·Phase: PHASE4
-
Once-A-Day Pregabalin For Partial Seizures
NCT01262677 ·Status: COMPLETED ·Phase: PHASE3
-
Evaluating Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures
NCT00700310 ·Status: COMPLETED ·Phase: PHASE3
-
4-Year Open-Label Extension Phase of the Parallel-Group Study of E2007 in Patients With Refractory Partial Seizures
NCT00368472 ·Status: COMPLETED ·Phase: PHASE2
-
Pharmacokinetic Study With an Oral Suspension of Perampanel as Adjunctive Therapy in Pediatric Subjects With Epilepsy
NCT02914314 ·Status: COMPLETED ·Phase: PHASE2
-
Perampanel for Treatment of Adults With Refractory Focal Epilepsy : a Pilot Study.
NCT02727101 ·Status: TERMINATED ·Phase: PHASE4
-
A Study to Evaluate the Dosing, Effectiveness and Safety of Topiramate for the Treatment of Epilepsy
NCT00266604 ·Status: COMPLETED ·Phase: PHASE4
-
A Study to Evaluate the Safety and Efficacy of Zonisamide an Antiepileptic Drug as Monotherapy or Adjunctive Therapy in Treatment of Adult Patients With Partial, Generalized or Combined Seizures.
NCT01283256 ·Status: COMPLETED
-
A Randomized, Controlled Trial of Ganaxolone in Adult Uncontrolled Partial-Onset Seizures
NCT00465517 ·Status: COMPLETED ·Phase: PHASE2