CompletedPhase 4

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

United States54 participantsStarted 2017-08-23

Plain-language 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).

Who can participate

Age range4 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. At least two unprovoked (or reflex) seizures occurring greater than 24 hours apart
✓. One unprovoked (or reflex) seizure with Electroencephalography (EEG) evidence of seizures

What they're measuring

Percentage of Participants Remaining on Perampanel Treatment at 3 Months After the Initiation of Treatment

Timeframe: Month 3

Percentage of Participants Remaining on Perampanel Treatment at 6 Months After the Initiation of Treatment

Timeframe: Month 6

Percentage of Participants Remaining on Perampanel Treatment at 9 Months After the Initiation of Treatment

Timeframe: Month 9

Percentage of Participants Remaining on Perampanel Treatment at 12 Months After the Initiation of Treatment

Timeframe: Month 12

Trial details

NCT IDNCT03288129

SponsorEisai Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-04-27

Results submitted2022-04-21

View on ClinicalTrials.gov More Partial Onset Seizures trials