FYC02T: 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

• Sponsor: Eisai Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03059381
• Collaborator: (none)
• Enrollment: 519
• Locations: 2
• Actual Duration (Months): 55.6
• Patients Per Site: 259.5
• Patients Per Site Per Month: 4.7

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Partial Seizures (With or Without Secondary Generalized Seizures); Primary Generalized Tonic-clonic Seizures	Drug: Fycompa

Study Design

• Study Type: Observational
• Actual Enrollment: 519 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: 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
• Actual Study Start Date: Aug 1, 2016
• Actual Primary Completion Date: Mar 21, 2021
• Actual Study Completion Date: Mar 21, 2021

Arms and Interventions

Arm

Intervention/Treatment

Fycompa-treated epilepsy participants 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

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.

Outcome Measures

Primary Outcome Measures

1. Number of participants with any serious adverse event [from 0 to 104 weeks]

2. Number of participants with any non-serious adverse event [from 0 to 104 weeks]

Secondary Outcome Measures

1. Number of participants experiencing seizures [from 0 to 104 weeks]

2. Overall improvement rating in seizure frequency [from 0 to 104 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Osaka		Japan
2		Tokyo		Japan

Sponsors and Collaborators

• Eisai Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eisai Co., Ltd.
• ClinicalTrials.gov Identifier: NCT03059381
• Other Study ID Numbers: E2007-M081-503
• First Posted: Feb 23, 2017
• Last Update Posted: Aug 5, 2022
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Eisai Co., Ltd.: adolescent epilepsy participants; partial seizures; primary generalized Tonic-clonic seizures
• Additional relevant MeSH terms: Neoplasm Metastasis; Epilepsy; Seizures

Study Results

No Results Posted as of Aug 5, 2022