Last updated on March 2019

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


Brief description of study

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).

Clinical Study Identifier: NCT03059381

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Recruitment Status: Open


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