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

NCT03059381 | Completed

• 1 other identifier: E2007-M081-503
• Study Type: observational
• Target: 519
• Locations: 1 country
• Sites: 2

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. 1.unknown adverse drug reactions (ADRs);
2. 2.occurrence of ADRs;
3. 3.factors that are likely to affect safety and efficacy;
4. 4.occurrence of dizziness, balance disorders, ataxia, muscle relaxation-related adverse events, and falls as priority investigation items;
5. 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

Keywords

adolescent epilepsy participants; partial seizures; primary generalized Tonic-clonic seizures

Outcome Measures

Primary Outcomes (2)

• Number of participants with any serious adverse event

  from 0 to 104 weeks

• Number of participants with any non-serious adverse event

  from 0 to 104 weeks

Secondary Outcomes (2)

• Number of participants experiencing seizures

  from 0 to 104 weeks

• Overall improvement rating in seizure frequency

  from 0 to 104 weeks

Study Arms (1)

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

Interventions

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.

Fycompa-treated epilepsy participants

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Participants with epilepsy who will receive Fycompa per the approved indication in routine clinical practice

You may qualify if:

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

You may not qualify if:

• Participants previously treated with Fycompa

Sponsors & Collaborators

• Eisai Co., Ltd.: lead

Study Sites (2)

Unknown Facility

Osaka, Japan

Location

Unknown Facility

Tokyo, Japan

Location

Related 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):813-821. doi: 10.1684/epd.2022.1454.

  PMID: 35792849 RESULT

MeSH Terms

Conditions

Seizures

Interventions

perampanel

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2017
• First Posted: February 23, 2017
• Study Start: August 1, 2016
• Primary Completion: March 21, 2021
• Study Completion: March 21, 2021
• Last Updated: August 5, 2022

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

JP (2)