Effect of alcohol administration on Perampanel

• Research type

  Research Study

• Full title

  A Phase 1 Study in healthy subjects to determine the safety, tolerability, psychomotor function and cognitive effects of Perampanel when administered with alcohol

• IRAS ID

  40210

• Contact name

  Daryl Bendel

• Sponsor organisation

  Eisai Limited

• Eudract number

  2009-010799-20

• ISRCTN Number

  xx

• Research summary

  This is a Phase 1 study in healthy subjects to determine the safety, tolerability, psychomotor function and cognitive effects of Perampanel (how it effects daytime performance) when administered alone and with alcohol. The study will take place at one site in the UK, the Surrey Clinical Research Centre. The study has 2 parts. Part A is a single blind study which will investigate the effects of a single dose of Perampanel when given alone and with alcohol. A single blind design has been chosen as the long half life of Perampanel makes the usual crossover design impractical. Subjects will attend for screening and baseline periods to be assessed for eligibility and to establish baseline values. Subjects will then be admitted to the clinic for 5 days and will be given Perampanel or placebo with alcohol on 2 consecutive days and assessments will be made to establish the effects on subject??s attention, concentration, response time and balance. Three cohorts of 12 subjects each will be given increasing doses of Perampanel (4mg to 12mg). Part B is a randomised double blind placebo controlled study and will enrol 24 subjects. Again subjects will attend for screening and baseline periods to be assessed for eligibility and to establish baseline values. Subjects will be admitted for 43 days and will be given increasing doses of Perampanel (4mg to 12 mg titrated at weekly increments to steady state) over a period of 34 days. Alcohol will be given during this period on 5 occasions to see how this combination affects their alertness, attention, concentration, reaction time, memory balance and driving performance.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  10/H0802/20

• Date of REC Opinion

  21 Apr 2010

• REC opinion

  Further Information Favourable Opinion