CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 20 enrolled
Drug / intervention
Perampanel Oral Tabletdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03457129
NCT03457129Phase 4Completed
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Fycompa Titration Intervals and Effects on Retention Rate

University of Arizona·interventional·Posted Mar 7, 2018·Updated Aug 15, 2023

In Brief

A Phase 4 clinical trial evaluating Perampanel Oral Tablet for Epilepsy. Completed, enrolled 20 participants across 1 site.

Detailed Summary

This study will aim to improve retention and tolerability by slowing the initial titration rate of perampanel from a standard up-titration rate of 2 week intervals to a slower up-titration rate consisting of 3 week intervals. Subjects will be randomized to either perampanel, standard titration interval rate (Group A) or perampanel, slower titration interval rate (Group B).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy
CountriesUnited States
CollaboratorsEisai Inc.

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedMar 7, 2018
Enrollment StartApr 18, 2018
Primary CompletionFeb 24, 2021
Study CompletionDec 15, 2021
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 8.3 years ago

Interventions

Perampanel Oral Tabletdrug

Perampanel is an AMPA receptor blockade, that has shown to be efficacious for seizure reduction in both partial onset seizures and generalized tonic-clonic seizures. Perampanel was approved by the FDA in October 2012 as adjunctive treatment in patients with partial onset seizures. Additionally, in June 2015, Fycompa was approved as adjunctive therapy in patients with primary generalized tonic clonic seizures.