TerminatedPhase 3

Study of Perampanel as Adjunctive Treatment for Inadequately Controlled Seizures Associated With Lennox-Gastaut Syndrome

Stopped: Sponsor's decision

United States101 participantsStarted 2016-12-13

Plain-language summary

This study is being conducted to demonstrate that perampanel given as adjunctive anti-epileptic treatment is superior to placebo in reducing the number of drop seizures in participants with inadequately controlled seizures associated with Lennox-Gastaut Syndrome (LGS).

Who can participate

Age range2 Years

SexALL

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Inclusion criteria

✓. more than one type of generalized seizure, including drop seizures (atonic, tonic, or myoclonic) for at least 6 months before Visit 1;
✓. an electroencephalogram (EEG) reporting diagnostic criteria for LGS at some point in their history (abnormal background activity accompanied by slow, spike, and wave pattern \<2.5 hertz \[Hz\]).

What they're measuring

Core Study Phase: Median Percent Change in Drop Seizure Frequency Per 28 Days During Double-blind Treatment Relative to the Prerandomization Phase (Baseline)

Timeframe: Baseline up to 18 weeks

Trial details

NCT IDNCT02834793

SponsorEisai Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-05-26

Results submitted2022-02-11

View on ClinicalTrials.gov More Lennox-Gastaut Syndrome (LGS) trials