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NCT03059381: FYC02T
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
trial testing Fycompa in Partial Seizures (With or Without Secondary Generalized Seizures) in 519 participants. Completed in 21 March 2021.
21 March 2021
Quick facts
| Lead sponsor | Eisai Co., Ltd. |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 519 |
| Start date | 1 August 2016 |
| Primary completion | 21 March 2021 |
| Estimated completion | 21 March 2021 |
| Sites | 2 locations across Japan |
Drugs / interventions tested
- Fycompa (PERAMPANEL) — full drug profile →
Conditions studied
- Partial Seizures (With or Without Secondary Generalized Seizures) — all drugs for Partial Seizures (With or Without Secondary Generalized Seizures) →
- Primary Generalized Tonic-clonic Seizures — all drugs for Primary Generalized Tonic-clonic Seizures →
Sponsor
Eisai Co., Ltd. — full company profile →
Who can join
Adults 12 to 17, any sex, with Partial Seizures (With or Without Secondary Generalized Seizures) or Primary Generalized Tonic-clonic Seizures. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03059381
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Fycompa
Trials testing the same drug.
- NCT05201703 — Fycompa in Catamenial Epilepsy · Phase 4 · terminated
- NCT03377309 — Safety and Tolerability of Perampanel in Amyotrophic Lateral Sclerosis Patients · Phase 2 · terminated
- NCT03208660 — Study to Investigate Dosage, Efficacy, and Safety of Fycompa in Routine Clinical Care of Patients With Epilepsy · completed
- NCT03059329 — Investigation of the Clinical Safety and Efficacy of Long-term Treatment With Fycompa Tablets in Adult Epilepsy Patients · completed
Other Eisai Co., Ltd. trials
Trials by the same sponsor.
- NCT07515014 — A Study of E6742 in Participants With Systemic Lupus Erythematosus · Phase 2 · not yet recruiting
- NCT06793709 — A Post-marketing Observational Study of Tasfygo in Participants With Unresectable Biliary Tract Cancer With Fibroblast G · recruiting
- NCT06657378 — A Study to Evaluate the Safety of Fycompa Injection in Participants With Partial-Onset Seizures or Primary Generalized T · recruiting
- NCT06322667 — A Post Marketing Study in Participants With Early Alzheimer's Disease Treated With Lecanemab · recruiting
- NCT05633108 — A Study Based on the French National Health Insurance Database in Participants With Psychotic Disorders · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03059381 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Eisai Co., Ltd.
- Last refreshed: 5 August 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03059381.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing