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

Primary Generalized Tonic-clonic Seizures Clinical Trial

— FYC02T  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03059381
• Other study ID #: E2007-M081-503
• Status: Completed
• Start date: August 1, 2016
• Est. completion date: March 21, 2021

Study information

• Verified date: April 2021
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 519
• Est. completion date: March 21, 2021
• Est. primary completion date: March 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy
• Neoplasm Metastasis
• Partial Seizures (With or Without Secondary Generalized Seizures)
• Primary Generalized Tonic-clonic Seizures
• Seizures

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Co., Ltd.

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Inoue Y, Sumitomo K, Matsutani K, Ishii M. Real-world evaluation of perampanel effectiveness in Japanese adolescents with epilepsy. Epileptic Disord. 2022 Oct 1;24(5):1-9. doi: 10.1684/epd.2022.1454. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with any serious adverse event		from 0 to 104 weeks
Primary	Number of participants with any non-serious adverse event		from 0 to 104 weeks
Secondary	Number of participants experiencing seizures		from 0 to 104 weeks
Secondary	Overall improvement rating in seizure frequency		from 0 to 104 weeks