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OpenTrials
Completed

NCT Number: NCT03059381

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

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).

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Key information

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Osaka, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Epilepsy participants from 12 to 17 years of age with:
  • Partial seizures (with or without secondary generalized seizures)
  • Primary generalized Tonic-clonic seizures

Exclusion criteria

  • Participants previously treated with Fycompa

Treatment and study plan

Fycompa

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.

Primary outcomes

  1. Number of participants with any serious adverse event

    Time frame: from 0 to 104 weeks

  2. Number of participants with any non-serious adverse event

    Time frame: from 0 to 104 weeks

Secondary outcomes

  1. Number of participants experiencing seizures

    Time frame: from 0 to 104 weeks

  2. Overall improvement rating in seizure frequency

    Time frame: from 0 to 104 weeks

Sponsors and collaborators

Lead sponsor

Eisai Co., Ltd.

Industry

Registry information

Acronym: FYC02T

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Feb 23, 2017
Registry last updated
Aug 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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