Preladenant in Subjects with Moderate to Severe PD (P04938)

• Research type

  Research Study

• Full title

  A Phase 3, 12-Week, Double-Blind, Double-Dummy,Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects with Moderate to Severe Parkinson’s Disease. (Phase 3; Protocol No. P04938)

• IRAS ID

  58362

• Contact name

  David Burn

• Sponsor organisation

  Schering-Plough Research Institute

• Eudract number

  2009-015161-31

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This study will be evaluating the use of various doses of preladenant compared to placebo and rasagiline in the treatment of moderate to severe Parkinson's disease. Adult patients with a diagnosis of moderate to severe idiopathic Parkinson's disease will be selected to participate in the trial.Each patient will participate in the trial for approximately 13 to 15 weeks consisting of up to 3 weeks for the screening phase followed by approximately 12 weeks of treatment.Patients will be randomly placed into 1 of 5 treatment groups to receive 2 mg, 5 mg, or 10 mg of preladenant twice daily, placebo twice daily, or 1 mg rasagiline once daily. Neither the participant or the study doctor will know whichtreatment the participant will be taking.After the End of Treatment, participants may choose to enrol in an extension trial (up until the maximum number of subjects for that extension trial has been reached) or return for a Followup Visit 2 weeks after the last dose of study drug.

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  10/H0505/89

• Date of REC Opinion

  7 Mar 2011

• REC opinion

  Further Information Favourable Opinion