A Placebo-Controlled Study With an Open-Label Extension Phase of Perampanel as Adjunctive Treatment in Subjects at Least 2 years of Age With Inadequately Controlled Seizures Associated With Lennox-Gastaut Syndrome

What we are studying

The purpose of this research study is to investigate whether perampanel, when used with other treatments, is more effective at treating patients with Lennox-Gastaut Syndrome compared to using only the treatments you are currently on.

Who is Eligible

  • Genders:
    • Men
    • Women
  • Races:
    • White
    • African American
    • Asian
    • American Indian or Alaska Native
    • Native Hawaiian or Pacific Islander
    • Other
  • All Ethnicities
  • Ages 2+

Eligibility Criteria

  • Inclusion Criteria:
    • 1. Participants must be at least 2 years old with a weight of at least 8 kg (17.6 lbs) 2. Participants must have a diagnosis of Lennox-Gastaut Syndrome (LGS) 3. Participants must being experiencing at least 2 drop seizures per week 4. Participants must be receiving 1 to 3 concomitant antiepileptic drugs (AEDs) at a stable dose for at least 30 days 5. Parents or caregivers must be able to keep accurate seizure diaries Exclusion criteria
    • 1. Presence of progressive neurological disease. 2. Scheduled for epilepsy-related surgery or any other form of surgery during course of study 3. Status epilepticus within 12 weeks of Screening visit

What is involved

  • This study consists of 2 parts: the Core Study and the Extension Study. The Core study can last up to 30 weeks. If you complete the Core Study and the study doctor finds you eligible
  • You may enter the Extension Study if you agree. The Extension Study can last up to 53 weeks.

Compensation

$50 per visit completed

Contact Information

Study Coordinator
Jessica Dimos
Email
[email protected]
Phone
-8694
Principal Investigator
Gautam Popli, MD

Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.