A Study to Investigate Dosage, Effectiveness, and Safety of Perampanel When Used as First Add-on Therapy in Participants >=12 Years With Partial Onset Seizures With or Without Secondary Generalization or With Primary Generalized Tonic-Clonic Seizures Associated With Idiopathic Generalized Epilepsy

NCT04252846 | Completed FDA Drug

• 1 other identifier: E2007-M044-512
• Study Type: observational
• Target: 191
• Locations: 7 countries
• Sites: 36

Brief Summary

The primary purpose of this study is to assess the retention rate of perampanel as a reliable proxy for overall effectiveness and tolerability in participants aged at least 12 years who are prescribed perampanel (for partial onset seizures \[POS\] with or without secondary generalization \[SG\] or for primary generalized tonic-clonic seizures \[PGTCS\] associated with idiopathic generalized epilepsy \[IGE\] as first adjunctive to antiepileptic drug (AED) monotherapy as part of their routine clinical care.

Conditions

Idiopathic Generalized Epilepsy; Partial Onset Seizures; Generalised Tonic-Clonic Seizures

Keywords

Perampanel; Fycompa; Epilepsy; Seizures; Prospective

Outcome Measures

Primary Outcomes (1)

• Retention Rate at Month 12

  Retention rate at 12 months is defined as the percentage of participants remaining on perampanel at 12 months.

  Month 12

Secondary Outcomes (10)

• Retention Rate at Month 6

  Month 6

• Pragmatic Seizure-free Rate at Months 6 and 12

  Months 6 and 12

• Completer Seizure-free Rate at Months 6 and 12

  Months 6 and 12

• Median Percent Change From Baseline in Seizure Frequency at Months 6 and 12

  Months 6 and 12

• 50 Percent (%) Responder Rate at Months 6 and 12

  Months 6 and 12

Study Arms (1)

Perampanel

Participants with a diagnosis of epilepsy (POS with or without SG or PGTCS associated with IGE) will initiate treatment with perampanel as first adjunctive treatment as per the clinical judgment of the treating physician as part of routine clinical care. All participants will be observed prospectively for up to 12 months after initiation of perampanel treatment.

Drug: Perampanel

Interventions

Perampanel DRUG

Perampanel oral tablets or oral suspension.

Also known as: Fycompa

Perampanel

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Approximately 300 participants with diagnosis of epilepsy (POS with or without SG or PGTCS associated with IGE)

You may qualify if:

• Diagnosis of epilepsy
• History of POS with or without SG or PGTCS associated with IGE
• Documented POS with or without SG or PGTCS associated with IGE, within the past 12 months
• Previously treated with 1 or 2 AEDs as monotherapy
• At least 4 weeks' seizure diary data, or sufficient clinical detail to calculate baseline seizure frequency

You may not qualify if:

• Episode(s) of status epilepticus within the past 6 months before Screening
• Previously treated with 2 or more AEDs in combination (other than during cross-titration between AED monotherapies)
• Previous or current use of perampanel
• Hypersensitivity to perampanel or any of the excipients

Sponsors & Collaborators

• Eisai Limited: lead

Study Sites (36)

Sydvestjysk Sygehus Esbjerg

Esbjerg, Region Syddanmark, Denmark

Location

Hôpital Pontchaillou

Rennes, Ille-et-Vilaine, France

Location

Hôpital Roger Salengro

Lille, Nord, France

Location

Centre de consultations Saint-Jean Bâtiment A

Cagnes-sur-Mer, France

Location

Hopitaux de La Timone

Marseille, France

Location

Hôpital Robert Debré

Paris, France

Location

Centre hospitalier de Pau

Pau, France

Location

Centre Hospitalier Universitaire de Toulouse

Toulouse, France

Location

CHRU Bretonneau

Tours, France

Location

Eisai Trial Site #2

Berlin, Germany

Location

Eisai Trial Site #1

Ulm, Germany

Location

AORN A Cardarelli

Naples, Campania, Italy

Location

Azienda Sanitaria Universitaria Integrata di Udine - PO Universitario Santa Maria della Misericordia

Udine, Friuli Venezia Giulia, Italy

Location

Fondazione PTV Policlinico Tor Vergata

Rome, Lazio, Italy

Location

ASST Santi Paolo e Carlo - Azienda Universitaria-Polo Universitario San Paolo

Milan, Lombardy, Italy

Location

Ospedale di Merano

Merano, Trentino-Alto Adige, Italy

Location

Ospedale Santa Maria Della Misericordia Di Perugia

Perugia, Umbria, Italy

Location

Ospedale Policlinico San Martino

Genova, Italy

Location

Azienda Ospedaliera Universitaria Federico II

Napoli, Italy

Location

Policlinico Universitario Campus Biomedico Di Roma

Roma, Italy

Location

Centro Hospitalar E Universitário de Coimbra EPE

Coimbra, Portugal

Location

Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria

Lisbon, Portugal

Location

Centro Hospitalar de São João, E.P.E.

Porto, Portugal

Location

Krasnoyarsk State Medical University n.a. V.F. Voyno-Ysenetskiy

Krasnoyarsk, Russia

Location

City Clinical Hospital #1 n.a. N.I.Pirogov

Moscow, Russia

Location

Moscow State Medical Stomatological University n.a. A.I. Evdokimov

Moscow, Russia

Location

Russian National Research Medical University n.a. N.I.Pirogov

Moscow, Russia

Location

City Neurology Center Sibneuromed LLC

Novosibirsk, Russia

Location

Regional Treatment and Rehabilitation Center

Tyumen, Russia

Location

CHUVI - H.U. Alvaro Cunqueiro

Vigo, Pontevedra, Spain

Location

Hospital Universitari Sagrat Cor Quironsalud

Barcelona, Spain

Location

Hospital Universitario Virgen de Las Nieves

Granada, Spain

Location

Hospital Regional Universitario de Malaga - Hospital General

Málaga, Spain

Location

Hospital Universitario de Donostia

San Sebastián, Spain

Location

Hospital Universitario Virgen Macarena

Seville, Spain

Location

Hospital Clinico Universitario de Valladolid

Valladolid, Spain

Location

MeSH Terms

Conditions

Epilepsy, Idiopathic Generalized; Epilepsy, Tonic-Clonic; Epilepsy; Seizures

Interventions

perampanel

Condition Hierarchy (Ancestors)

Epilepsy, Generalized; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; 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: January 31, 2020
• First Posted: February 5, 2020
• Study Start: July 20, 2020
• Primary Completion: January 12, 2023
• Study Completion: January 12, 2023
• Last Updated: February 9, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share

Locations

DK (1); PT (3); FR (8); IT (9); RU (6); ES (7); DE (2)