Efficacy Study of Rotigotine on Parkinson's Disease Associated Pain

• Research type

  Research Study

• Full title

  A MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO-CONTROLLED, TWO-ARM STUDY TO EVALUATE THE EFFICACY OF ROTIGOTINE ON PARKINSON’S DISEASE ASSOCIATED PAIN

• IRAS ID

  112832

• Contact name

  Kallol Ray Chaudhuri

• Sponsor organisation

  UCB BIOSCIENCES GmbH

• Eudract number

  2012-002608-42

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  As well as affecting movement, people with Parkinson's disease can suffer other symptoms. Pain is a common symptom in Parkinson’s disease. Nevertheless, pain was under-diagnosed as a symptom of Parkinson’s disease in the past, but it is now considered to play a major role in patients suffering from Parkinson’s disease. Rotigotine is currently approved in the UK for treatment of Parkinson’s disease at an early and advanced stage. This study is being conducted to evaluate how effective Rotigotine is on chronic pain symptoms associated with Parkinson’s disease Approximately 478 subjects are planned for enrollment at approximately 92 investigative sites globally. This study includes a Screening Period of up to 4 weeks that includes the Screening Visit, an up to 7-week Titration Period (dose titration will occur on a weekly basis), a 12-week Maintenance Period, a maximum 12-day De-Escalation Period, and a 28-day Safety Follow-Up Period. After the Screening Period, The participants will be assigned by chance to receive either Rotigone or placebo (no medication) in the form of transdermal patches. The participants will have a 50% chance of receiving the Rotigone. Neither the study doctor nor the participant will know what medication the participant will be receiving. During the titration period, participants will start on a dose of 4mg/24hrs for 1 week and the dose will then be increased by 2mg/24h until the optimal or maximal dose is reached. The dose will be regarded as optimal if both the investigator and the participant consider the symptoms adequately controlled. The maximum dose will be 16mg/24hrs. Maximum duration is 29 weeks, depending on the individual duration of the screening period and the individual optimal dose of medication. During the study, the participants will undergo a number of procedures including a physical and neurological examination and completion of various questionnaires.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  13/LO/0079

• Date of REC Opinion

  7 Apr 2013

• REC opinion

  Further Information Favourable Opinion