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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

NCT03059329 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 3809

Last updated 2022-03-02

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Eisai Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Kenta Sumitomo · Drug Fostering and Evolution Coordination Department. Medical Division

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-01
Primary Completion
2019-09-13
Completion
2019-09-13

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03059329 on ClinicalTrials.gov