Sleep efficiency assessed by PSG in advanced Parkinson's disease

• Research type

  Research Study

• Full title

  REFRESH-PD RANDOMIZED EVALUATION FOR ROTIGOTINE’S EFFICACY IN SLEEP IN IDIOPATHIC PD PATIENTS A MULTI-CENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE EFFECTS OF ROTIGOTINE ON SLEEP EFFICIENCY IN PATIENTS WITH ADVANCED PARKINSON’S DISEASE

• IRAS ID

  78893

• Contact name

  Paul Reading

• Sponsor organisation

  UCB Pharma SA

• Eudract number

  2011-000056-42

• ISRCTN Number

  No number provided

• Clinicaltrials.gov Identifier

  No number provided

• Research summary

  Phase 4, randomised, double-blind, placebo-controlled study to evaluate the effects of Rotigotine on sleep efficiency in patients with advanced Parkinson's disease.As well as affecting movement, people with Parkinson's disease can find that other issues, such as sleep-related problems, can have an impact on their day-to-day lives. Rotigotine is currently approved in the UK for treatment of Parkinson's disease and Restless Leg Syndrome. This study is being conducted to evaluate how effective Rotigotine is in improving sleep efficiency compared with placebo. The study will only take place in the UK. Approximately 60 patients in 15 clinical sites (hospitals and/or sleep laboratories) will participate. The participants will be assigned by chance to receive either Rotigone or placebo (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. The study will consist of a screening, titration, maintenance, de-escalation and safety follow-up period. 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 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. During the maintenance period, the participant will stay on the stable dose for 4 weeks and their sleep efficiency will be assessed during 2 consecutive nights before the de-escalation period starts.The participants will be in the study for up to a maximum of 21 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, completion of questionnaires and polysomnography.

• REC name

  London - Dulwich Research Ethics Committee

• REC reference

  11/LO/1260

• Date of REC Opinion

  25 Oct 2011

• REC opinion

  Further Information Favourable Opinion