Preladenant in Subjects with Moderate to Severe PD (Extn Study:P06153)

• Research type

  Research Study

• Full title

  A Phase 3, 40-Week, Active-Controlled, Double-Blind, Double Dummy Extension Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3, Protocol No. P06153)

• IRAS ID

  77000

• Sponsor organisation

  MSD Ltd

• Eudract number

  2009-015162-57

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This is an extension study to protocol P04938 to be conducted in patients with moderate to severe Parkinson's disease. The aim of this study is to assess the long-term safety and tolerability of preladenant in this patient group. Patients will be able to enter this study on completion of P04938. In this study (P06153), each patient will participate for approximately 42 weeks ie, 40 weeks of active treatment followed by a 2-week Safety Follow-Up Visit.The treatment groups in P06153 will include preladenant 2, 5, and 10 mg twice daily and rasagiline 1 mg once daily. Each patient will receive the same treatment as in P04938, with the exception of those who received placebo who will have equal chance of receiving either preladenant 5 mg twice daily or rasagiline 1 mg once daily. This is a double-blind study which means neither the patient or the study doctor will know which treatment the patient will be taking.

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  11/SC/0251

• Date of REC Opinion

  16 Aug 2011

• REC opinion

  Further Information Favourable Opinion