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)

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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