Preladenant in Subjects with Early PD (P05664)

• Research type

  Research Study

• Full title

  A Phase 3, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose-Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson’s Disease (Phase 3 Protocol No. P05664)

• IRAS ID

  58512

• Contact name

  David Burn

• Sponsor organisation

  Schering-Plough Research Institute

• Eudract number

  2009-013552-72

• 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 early Parkinson's disease. Adult patients with a diagnosis of early Parkinson's disease will be selected to participate in this study.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 once daily, or 1 mg rasagiline once daily. Neither the patient or the study doctor will know which treatment the patient will be taking.Each patient will participate in the trial for approximately 54 to 57 weeks. After a Screening Period of up to 3 weeks, patients will enter into Part 1 of the treatment period and receive treatment for approximately 26 weeks (2 mg, 5 mg, or 10 mg preladenant twice daily, placebo, or 1 mg rasagiline once daily). At Week 26, subjects will enter Part 2 of the study where the patients who had been on placebo in Part 1 will be re-assigned to preladenant 5 mg twice daily. All other patients will stay on the same treatment as in Part 1. Part 2 will consist of 26 weeks of treatment.

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  10/H0505/90

• Date of REC Opinion

  7 Mar 2011

• REC opinion

  Further Information Favourable Opinion