Sleep Efficiency Assessed by Polysomnography (PSG Sleep Lab Testing) in Advanced Parkinson's Disease (REFRESH-PD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01519882|
Recruitment Status : Terminated (Due to major recruitment issues, a decision was made to terminate this trial)
First Posted : January 27, 2012
Results First Posted : January 28, 2014
Last Update Posted : March 3, 2014
|Study Design||Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment|
Advanced Idiopathic Parkinson's Disease
|Recruitment Details||The study started in March 2012 and was conducted in the United Kingdom. It was terminated due to recruitment issues in January 2013.|
|Pre-assignment Details||1 subjects was randomized to Placebo and started and completed the study (from Screening (Week 0) to the Safety Follow-Up Visit (Week 18)).|
Despite many attempts by study sites to recruit subjects, only 1 subject was randomized by Oct 2012. The decision to terminate the study was taken in Nov 2012. The subject completed in Jan 2013.
No planned efficacy/safety analyses were performed.