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Sleep Efficiency Assessed by Polysomnography (PSG Sleep Lab Testing) in Advanced Parkinson's Disease (REFRESH-PD)

This study has been terminated.
(Due to major recruitment issues, a decision was made to terminate this trial)
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Pharma SA )
ClinicalTrials.gov Identifier:
NCT01519882
First received: January 24, 2012
Last updated: January 29, 2014
Last verified: January 2014
Results First Received: December 10, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Advanced Idiopathic Parkinson's Disease
Interventions: Other: Placebo
Other: Rotigotine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
1 subjects was randomized to Placebo and started and completed the study (from Screening (Week 0) to the Safety Follow-Up Visit (Week 18)).

Reporting Groups
  Description
Placebo

Placebo Transdermal Patches

Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.

Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day.

Rotigotine

Rotigotine Transdermal Patches

Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.

Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day.


Participant Flow:   Overall Study
    Placebo     Rotigotine  
STARTED     1     0  
COMPLETED     1     0  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo

Placebo Transdermal Patches

Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.

Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day.

Rotigotine

Rotigotine Transdermal Patches

Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.

Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day.

Total Total of all reporting groups

Baseline Measures
    Placebo     Rotigotine     Total  
Number of Participants  
[units: participants]
  1     0     1  
Age  
[units: participants]
     
<=18 years     0         0  
Between 18 and 65 years     0         0  
>=65 years     1         1  
Age  
[units: years]
Mean ± Standard Deviation
  67  ± NA [1]       67  ± NA [1]
Gender  
[units: participants]
     
Female     1         1  
Male     0         0  
Region of Enrollment  
[units: participants]
     
United Kingdom     1         1  
[1] The mean presented here is the individual age of the only subject included.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage Change From Baseline in Sleep Efficiency Index (SEI) to Week 4 of the Maintenance Period   [ Time Frame: From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline) ]

2.  Secondary:   Change From Baseline in the Parkinson’s Disease Sleep Scale Score Version 2 (PDSS2) to Day 1 of the Maintenance Period   [ Time Frame: From Baseline to Day 1 of the Maintenance Period (up to 7 weeks post-baseline) ]

3.  Secondary:   Change From Baseline in the Parkinson's Disease Sleep Scale Score Version 2 (PDSS2) to Week 4 of the Maintenance Period   [ Time Frame: From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline) ]

4.  Secondary:   Change From Baseline in the Epworth Sleepiness Score (ESS) to Day 1 of the Maintenance Period   [ Time Frame: From Baseline to Day 1 of the Maintenance Period (up to 7 weeks post-baseline) ]

5.  Secondary:   Change From Baseline in the Epworth Sleepiness Score (ESS) to Week 4 of the Maintenance Period   [ Time Frame: From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline) ]

6.  Secondary:   Change From Baseline in the Sleep Period Time in Non-Rapid Eye Movement (Non-REM) Sleep to Week 4 of the Maintenance Period   [ Time Frame: From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline) ]

7.  Secondary:   Change From Baseline in the Nocturnal Akinesia, Dystonia, and Cramps Score (NADCS) to Day 1 of the Maintenance Period   [ Time Frame: From Baseline to Day 1 of the Maintenance Period (up to 7 weeks post-baseline) ]

8.  Secondary:   Change From Baseline in the Nocturnal Akinesia, Dystonia and Cramps Score (NADCS) to Week 4 of the Maintenance Period   [ Time Frame: From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline) ]

9.  Secondary:   Change From Baseline in the Total Wake Time After Sleep Onset (WASO) to Week 4 of the Maintenance Period   [ Time Frame: From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline) ]

10.  Secondary:   Change From Baseline in the Total Number of Turnings in Bed to Week 4 of the Maintenance Period   [ Time Frame: From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data

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.



  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: UCB Clinical Trial Call Center
Organization: UCB
phone: +1 877 822 9493 (UCB)


No publications provided


Responsible Party: UCB Pharma ( UCB Pharma SA )
ClinicalTrials.gov Identifier: NCT01519882     History of Changes
Other Study ID Numbers: SP0919, 2011-000056-42
Study First Received: January 24, 2012
Results First Received: December 10, 2013
Last Updated: January 29, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency