At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 54 enrolled
Drug / intervention
Perampaneldrug
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.
Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Perampanel as Monotherapy or First Adjunctive Therapy in Subjects With Partial Onset Seizures With or Without Secondarily Generalized Seizures or With Primary Generalized Tonic-Clonic Seizures
In Brief
A Phase 4 clinical trial evaluating Perampanel for Partial Onset Seizures and 2 related conditions. Completed, enrolled 54 participants across 24 sites.
Detailed Summary
This study will assess the retention rate of perampanel when given as monotherapy or first adjunctive therapy in participants with partial-onset seizures or primary generalized tonic clonic seizures. The study consists of 4 periods: a Screening Period (to start no earlier than 6 weeks before the first dose of study drug), a Titration Period (up to 13 weeks), a Maintenance Period (39 weeks), and a Follow-Up Period (4 weeks).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPartial Onset Seizures, Secondarily Generalized Seizures, Primary Generalized Tonic-Clonic Seizures
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
201820192020202120222023202420252026
Enrollment StartAug 2017
First PostedSep 2017
Primary CompletionApr 2021
TodayJul 2026
First PostedSep 19, 2017
Enrollment StartAug 23, 2017
Primary CompletionApr 27, 2021
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 8.8 years ago
Interventions
Perampaneldrug
film-coated tablets