Trials / Completed
CompletedNCT03059381
Investigation of the Clinical Safety and Efficacy of Long-term Treatment With Fycompa Tablets in Adolescence Epilepsy Patients With Partial-onset Seizures (With or Without Secondary Generalized Seizures) or Primary Generalized Tonic-clonic Seizures
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 519 (actual)
- Sponsor
- Eisai Co., Ltd. · Industry
- Sex
- All
- Age
- 12 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to identify the following in adolescent epilepsy participants with partial-onset seizures (with or without secondary generalized seizures) or primary generalized Tonic-clonic seizures who receive long-term treatment with Fycompa: 1. unknown adverse drug reactions (ADRs); 2. occurrence of ADRs; 3. factors that are likely to affect safety and efficacy; 4. occurrence of dizziness, balance disorders, ataxia, muscle relaxation-related adverse events, and falls as priority investigation items; 5. occurrence of psychiatric adverse events as priority investigation items (eg, aggression).
Conditions
- Partial Seizures (With or Without Secondary Generalized Seizures)
- Primary Generalized Tonic-clonic Seizures
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2016-08-01
- Primary completion
- 2021-03-21
- Completion
- 2021-03-21
- First posted
- 2017-02-23
- Last updated
- 2022-08-05
Locations
2 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT03059381. Inclusion in this directory is not an endorsement.