Investigation of the Clinical Safety and Efficacy of Long-term Treatment With Fycompa Tablets in Adult Epilepsy Patients With Partial-onset Seizures (With or Without Secondary Generalized Seizures) or Primary Generalized Tonic-clonic Seizures

CompletedOBSERVATIONAL
Enrollment

3,809

Participants

Timeline

Start Date

August 1, 2016

Primary Completion Date

September 13, 2019

Study Completion Date

September 13, 2019

Conditions
Partial Seizures (With or Without Secondary Generalized Seizures)Primary Generalized Tonic-clonic Seizures
Interventions
DRUG

Fycompa

The usual oral dosage for adults and children 12 years of age or older is initially 2 milligrams (mg) once daily as perampanel at bedtime, and the daily dose may then be increased by 2 mg at intervals of 1 week or longer. The maintenance dose is 8 mg once daily in the absence of concomitant antiepileptic drugs that accelerate the metabolism of this product, or 8 to 12 mg once daily in the presence of such concomitant drugs. The dosage may be increased or decreased as necessary by 2 mg at intervals of 1 week or longer depending on symptoms, but the maximum daily dose should not be over 12 mg.

Trial Locations (2)

Unknown

Osaka

Tokyo

All Listed Sponsors
lead

Eisai Co., Ltd.

INDUSTRY

NCT03059329 - Investigation of the Clinical Safety and Efficacy of Long-term Treatment With Fycompa Tablets in Adult Epilepsy Patients With Partial-onset Seizures (With or Without Secondary Generalized Seizures) or Primary Generalized Tonic-clonic Seizures | Biotech Hunter | Biotech Hunter