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 (FYC01S)

Eisai

Status: Completed

Conditions: Primary Generalized Tonic-clonic Seizures; Partial Seizures (With or Without Secondary Generalized Seizures)

Treatments: Drug: Fycompa

Study type: Observational

Funder types: Industry

Identifiers

NCT03059329

E2007-M081-502

Details and patient eligibility

About

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).

Enrollment: 3,809 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Epilepsy participants at least 18 years of age with:

  • Partial seizures (with or without secondary generalized seizures)
  • Primary generalized Tonic-clonic seizures

Exclusion criteria

• Participants previously treated with Fycompa

Trial design

3,809 participants in 1 patient group

Fycompa-treated epilepsy participants

Description:

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

Treatment:

Drug: Fycompa