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
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StatusCompleted
Sponsors
Eisai Co., Ltd.
CLINICAL TRIAL: NCT03059329
BioSeek: nct03059329
Keywords
Abstract
The objective of this study is to identify the following in adult 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).
Dates
| Last Verified: | 03/31/2020 |
| First Submitted: | 02/16/2017 |
| Estimated Enrollment Submitted: | 02/19/2017 |
| First Posted: | 02/22/2017 |
| Last Update Submitted: | 04/02/2020 |
| Last Update Posted: | 04/05/2020 |
| Actual Study Start Date: | 07/31/2016 |
| Estimated Primary Completion Date: | 09/12/2019 |
| Estimated Study Completion Date: | 09/12/2019 |
Condition or disease
Partial Seizures (With or Without Secondary Generalized Seizures)
Primary Generalized Tonic-clonic Seizures
Intervention/treatment
Drug: Fycompa-treated epilepsy participants
Phase
-
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Fycompa-treated epilepsy participants Adult 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 | Drug: Fycompa-treated epilepsy participants 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. |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Sampling method | Probability Sample |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: - Epilepsy participants at least 18 years of age with: - Partial seizures (with or without secondary generalized seizures) - Primary generalized Tonic-clonic seizures Exclusion Criteria: - Participants previously treated with Fycompa |
Outcome
Primary Outcome Measures
1. Number of participants with any serious adverse event [from 0 to 52 weeks]
2. Number of participants with any non-serious adverse event [from 0 to 52 weeks]
Secondary Outcome Measures
1. Number of participants experiencing seizures [from 0 to 52 weeks]
2. Overall improvement rating in seizure frequency [from 0 to 52 weeks]
