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

NCT ID: NCT03059329

Last Updated: 2022-03-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 3809 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-08-01
• Study Completion Date: 2019-09-13

Brief Summary

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).

Conditions

Partial Seizures (With or Without Secondary Generalized Seizures); Primary Generalized Tonic-clonic Seizures

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Fycompa

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eisai Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kenta Sumitomo

Role: STUDY_DIRECTOR

Drug Fostering and Evolution Coordination Department. Medical Division

Locations

Osaka, , Japan

Tokyo, , Japan

Countries

Japan

References

Inoue Y, Sumitomo K, Matsutani K, Ishii M. Evaluation of real-world effectiveness of perampanel in Japanese adults and older adults with epilepsy. Epileptic Disord. 2022 Feb 1;24(1):123-132. doi: 10.1684/epd.2021.1369.

Reference Type: RESULT

PMID: 34782307 (View on PubMed)

Other Identifiers

E2007-M081-502

Identifier Type: -

Identifier Source: org_study_id