Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease-Associated Pain (DOLORES)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES GmbH )
ClinicalTrials.gov Identifier:
NCT01744496
First received: December 5, 2012
Last updated: April 9, 2015
Last verified: April 2015
Results First Received: November 24, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Advanced Idiopathic Parkinson's Disease
Interventions: Drug: Rotigotine
Drug: Placebo

  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 was conducted in Europe and USA. Recruitment was planned to continue until approximately 64 patients were randomized in the study. Subjects were randomized in a 1:1 ratio to either Rotigotine or Placebo. To achieve this, approximately 28 investigational sites were planned to participate in this hypothesis-generating pilot study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The Participant Flow population refers to the Randomized Set (RS). The RS includes all subjects who were randomized.

Reporting Groups
  Description
Placebo

Placebo Transdermal Patches

Placebo: Placebo patches matched the size of active patches 20 cm^2, 30 cm^2, or 40 cm^2 and contained Placebo. Application of Placebo patches started at the Baseline Visit. Placebo patches were administered once daily starting with the equivalent of 4 mg / 24 h. Doses were then up-titrated in weekly equivalents to 2 mg / 24 h until either optimal dose or maximum dose was reached. The maximum dose was the equivalent to 16 mg / 24 h. The duration of the Titration Period varied from 1 to 7 weeks. The Maintenance Period lasted 12 weeks ± 5 days. During the De-Escalation Period, the dose of Placebo will be decreased by the equivalent to 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days.

Rotigotine

Rotigotine Transdermal Patches

Rotigotine: Patches contained 4 mg / 24 h (20 cm^2), 6 mg/ 24 h (30 cm^2), or 8 mg /24 h (40 cm^2) of Rotigotine. Application of study medication started at the Baseline Visit. Rotigotine was administered once daily starting at 4 mg / 24 h. Doses were then up-titrated in weekly increments of 2 mg / 24 h until optimal or maximum dose (16 mg / 24 h) was reached and the Maintenance Period could be started. The duration of the Titration Period varied from 1 to 7 weeks ± 3 days. The Maintenance Period lasted 12 weeks ± 5 days. Thereafter, during the De-Escalation Period, the dose of study medication was decreased by 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days.


Participant Flow for 2 periods

Period 1:   Titration Period
    Placebo     Rotigotine  
STARTED     33     35  
COMPLETED     31     33  
NOT COMPLETED     2     2  
Adverse Event                 2                 1  
Personal reasons                 0                 1  

Period 2:   Maintenance Period
    Placebo     Rotigotine  
STARTED     31     33  
COMPLETED     27     29  
NOT COMPLETED     4     4  
Adverse Event                 1                 3  
Protocol Violation                 1                 0  
Withdrawal by Subject                 1                 1  
Subject left town                 1                 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.
The Baseline Analysis Population refers to the Safety Set (SS). The SS includes all randomized subjects who received at least 1 dose of study medication.

Reporting Groups
  Description
Placebo

Placebo Transdermal Patches

Placebo: Placebo patches matched the size of active patches 20 cm^2, 30 cm^2, or 40 cm^2 and contained Placebo. Application of Placebo patches started at the Baseline Visit. Placebo patches were administered once daily starting with the equivalent of 4 mg / 24 h. Doses were then up-titrated in weekly equivalents to 2 mg / 24 h until either optimal dose or maximum dose was reached. The maximum dose was the equivalent to 16 mg / 24 h. The duration of the Titration Period varied from 1 to 7 weeks. The Maintenance Period lasted 12 weeks ± 5 days. During the De-Escalation Period, the dose of Placebo was decreased by the equivalent to 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days.

Rotigotine

Rotigotine Transdermal Patches

Rotigotine: Patches contained 4 mg / 24 h (20 cm^2), 6 mg/ 24 h (30 cm^2), or 8 mg /24 h (40 cm^2) of Rotigotine. Application of study medication started at the Baseline Visit. Rotigotine was administered once daily starting at 4 mg / 24 h. Doses were then up-titrated in weekly increments of 2 mg / 24 h until optimal or maximum dose (16 mg / 24 h) was reached and the Maintenance Period could be started. The duration of the Titration Period varied from 1 to 7 weeks ± 3 days. The Maintenance Period lasted 12 weeks ± 5 days. Thereafter, during the De-Escalation Period, the dose of study medication was decreased by 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days.

Total Total of all reporting groups

Baseline Measures
    Placebo     Rotigotine     Total  
Number of Participants  
[units: participants]
  33     35     68  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     15     12     27  
>=65 years     18     23     41  
Age  
[units: years]
Mean (Standard Deviation)
  65.3  (13.8)     66.5  (11.9)     65.9  (12.8)  
Gender  
[units: participants]
     
Female     16     16     32  
Male     17     19     36  
Race/Ethnicity, Customized  
[units: participants]
     
American Indian / Alaskan native     0     0     0  
Asian     1     0     1  
Black     0     0     0  
Native Hawaiian or other Pacific Islander     0     0     0  
White     32     35     67  
Other / mixed     0     0     0  
Weight  
[units: kilograms]
Mean (Standard Deviation)
  80.15  (20.00)     77.80  (13.71)     78.94  (16.97)  
Height  
[units: centimeters]
Mean (Standard Deviation)
  167.17  (9.92)     168.63  (9.87)     167.92  (9.85)  
Body Mass Index (BMI)  
[units: kilogram per squaremeter]
Mean (Standard Deviation)
  28.54  (6.21)     27.42  (4.74)     27.96  (5.49)  



  Outcome Measures
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1.  Primary:   Change From Baseline to the End of the Maintenance Period in Pain Severity Assessed Using an 11-point Likert Pain Scale   [ Time Frame: Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after an up to 7 weeks Titration Period) ]

2.  Secondary:   Percentage of Responders at the End of the Maintenance Period   [ Time Frame: Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period) ]

3.  Secondary:   Change From Baseline to the End of the Maintenance Period in the Sum Score of the 8-Item Parkinson's Disease Questionnaire (PDQ-8)   [ Time Frame: Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period) ]

4.  Secondary:   Change From Baseline to the End of the Maintenance Period in the 7-Item Depression Subscore of the Hospital Anxiety and Depression Scale (HADS)   [ Time Frame: Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period) ]

5.  Secondary:   Change From Baseline to the End of the Maintenance Period in the 7-Item Anxiety Subscore of the Hospital Anxiety and Depression Scale (HADS)   [ Time Frame: Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period) ]

6.  Secondary:   Change From Baseline to the End of the Maintenance Period in the Combined Score of the Unified Parkinson's Disease Rating Scale (UPDRS) Parts II (Activities of Daily Living [ADL] Subscale) and III (Motor Subscale)   [ Time Frame: Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period) ]

7.  Secondary:   Change From Baseline to the End of the Maintenance Period in the 7 Domain Scores of Classification of Pain in Parkinson's Disease   [ Time Frame: Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period) ]


  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
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  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


No publications provided


Responsible Party: UCB Pharma ( UCB BIOSCIENCES GmbH )
ClinicalTrials.gov Identifier: NCT01744496     History of Changes
Other Study ID Numbers: PD0004, 2012-002608-42
Study First Received: December 5, 2012
Results First Received: November 24, 2014
Last Updated: April 9, 2015
Health Authority: Argentina: Ministry of Health
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines
Hungary: National Institute of Pharmacy
Mexico: Federal Commission for Protection Against Health Risks
Poland: Ministry of Health
Russia: Ministry of Health of the Russian Federation
Slovakia: State Institute for Drug Control
Ukraine: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration