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Rotigotine Versus Placebo to Evaluate the Efficacy on Depressive Symptoms in Idiopathic Parkinson's Disease Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Korea Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT01523301
First received: January 27, 2012
Last updated: November 16, 2015
Last verified: November 2015
Results First Received: October 12, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: 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
This double-blind, randomized, multicenter, placebo-controlled, in-Patient study started recruiting in April 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participant flow refers to the Randomized Set (RS), consisting of all randomized subjects.

Reporting Groups
  Description
Rotigotine

Rotigotine, daily doses, treatment Group.

Early-stage Parkinon´s disease for 1 week: Rotigotine dose at 2 mg/24 h. Advanced-stage Parkinson´s disease for 1 week: Rotigotine dose at 4 mg/24 h.

Afterwards the dose has been increased in the Titration Period by 2 mg/24 h each week until either the optimal or maximal dose was reached.

All subjects remained 8-weeks in the Maintenance Period. In the De-escalation Period Subjects with early-stage Parkinson´s disease de-escalated their dose by 2 mg/24 h every other day to 2 mg/24h, and then to 0 mg after 2 days. Subjects with advanced-stage Parkinson´s disease de-escalated their dose by 2 mg/24h every other day to 4 mg/24h, and then to 0 mg after 2 days.

A Safety Follow-Up Visit was scheduled for all subjects 30 days after their last dose administration.

Placebo

Placebo, daily doses, placebo Group. Subjects randomized to placebo received matching placebo patches.

Early-stage Parkinson´s disease for 1 week: Placebo patches´ dose at 2 mg/24 h. Advanced-stage Parkinson´s disease for 1 week: Placebo patches´dose at 4 mg/24 h.

Afterwards the dose has been increased in the Titration Period by 2 mg/24 h each week until either the optimal or maximal dose was reached.

All subjects remained 8-weeks in the Maintenance Period.

In the De-escalation Period Subjects with early-stage Parkinson´s disease de-escalated their dose by 2 mg/24 h every other day to 2 mg/24h, and then to 0 mg after 2 days. Subjects with advanced-stage Parkinson´s disease de-escalated their dose by 2 mg/24h every other day to 4 mg/24h, and then to 0 mg after 2 days.

A Safety Follow-Up Visit was scheduled for all subjects 30 days after their last dose administration.


Participant Flow:   Overall Study
    Rotigotine   Placebo
STARTED   184   196 
COMPLETED   149   164 
NOT COMPLETED   35   32 
Adverse Event                25                16 
Lack of Efficacy                0                2 
Protocol Violation                3                4 
Lost to Follow-up                1                0 
Withdrawal by Subject                6                8 
Other Reason                0                2 



  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.
Baseline Characteristics refer to the Randomized Set (RS), which consists of all randomized subjects.

Reporting Groups
  Description
Rotigotine

Rotigotine, daily doses, treatment Group.

Early-stage Parkinon´s disease for 1 week: Rotigotine dose at 2 mg/24 h. Advanced-stage Parkinson´s disease for 1 week: Rotigotine dose at 4 mg/24 h.

Afterwards the dose has been increased in the Titration Period by 2 mg/24 h each week until either the optimal or maximal dose was reached.

All subjects remained 8-weeks in the Maintenance Period. In the De-escalation Period Subjects with early-stage Parkinson´s disease de-escalated their dose by 2 mg/24 h every other day to 2 mg/24h, and then to 0 mg after 2 days. Subjects with advanced-stage Parkinson´s disease de-escalated their dose by 2 mg/24h every other day to 4 mg/24h, and then to 0 mg after 2 days.

A Safety Follow-Up Visit was scheduled for all subjects 30 days after their last dose administration.

Placebo

Placebo, daily doses, placebo Group. Subjects randomized to placebo received matching placebo patches.

Early-stage Parkinson´s disease for 1 week: Placebo patches´ dose at 2 mg/24 h. Advanced-stage Parkinson´s disease for 1 week: Placebo patches´dose at 4 mg/24 h.

Afterwards the dose has been increased in the Titration Period by 2 mg/24 h each week until either the optimal or maximal dose was reached.

All subjects remained 8-weeks in the Maintenance Period.

In the De-escalation Period Subjects with early-stage Parkinson´s disease de-escalated their dose by 2 mg/24 h every other day to 2 mg/24h, and then to 0 mg after 2 days. Subjects with advanced-stage Parkinson´s disease de-escalated their dose by 2 mg/24h every other day to 4 mg/24h, and then to 0 mg after 2 days.

A Safety Follow-Up Visit was scheduled for all subjects 30 days after their last dose administration.

Total Title No text entered.

Baseline Measures
   Rotigotine   Placebo   Total Title 
Overall Participants Analyzed 
[Units: Participants]
 184   196   380 
Age 
[Units: Years]
Mean (Standard Deviation)
 65.6  (8.9)   64.9  (8.2)   65.2  (8.5) 
Age, Customized 
[Units: Participants]
     
<=18 years   0   0   0 
>18-<65 years   76   88   164 
>=65 years   108   108   216 
Gender 
[Units: Participants]
     
Female   96   122   218 
Male   88   74   162 
Weight 
[Units: Kg]
Mean (Standard Deviation)
 61.54  (9.68)   62.24  (9.84)   61.90  (9.76) 
Height 
[Units: Cm]
Mean (Standard Deviation)
 160.04  (8.41)   159.17  (8.14)   159.59  (8.27) 


  Outcome Measures
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1.  Primary:   Change From Baseline to the End of Maintenance Period in the Score of the Hamilton Depression Scale (HAM-D)   [ Time Frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 15) ]

2.  Secondary:   Change From Baseline to the End of Maintenance Period in the Score of Beck Depression Inventory (BDI-II)   [ Time Frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 15) ]

3.  Secondary:   Change From Baseline to the End of Maintenance Period in the Score of Unified Parkinson’s Disease Rating Scale (UPDRS) Part II (Activities of Daily Living-ADL Subscale)   [ Time Frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 15) ]

4.  Secondary:   Change From Baseline to the End of Maintenance Period in the Score of Unified Parkinson’s Disease Rating Scale (UPDRS) Part III (Motor Subscale)   [ Time Frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 15) ]

5.  Secondary:   Change From Baseline to the End of Maintenance Period in the Combined Score of Unified Parkinson’s Disease Rating Scale (UPDRS) Part II (ADL) Plus Part III (Motor Subscale)   [ Time Frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 15) ]

6.  Secondary:   Change From Baseline to the End of Maintenance Period in the Score of Apathy Scale (AS)   [ Time Frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 15) ]

7.  Secondary:   Change From Baseline to the End of Maintenance Period in the Score of Snaith-Hamilton Pleasure Scale (SHAPS)   [ Time Frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 15) ]


  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
No text entered.


  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 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: UCB
phone: +1877 822 9493



Responsible Party: UCB Pharma ( UCB Korea Co., Ltd. )
ClinicalTrials.gov Identifier: NCT01523301     History of Changes
Other Study ID Numbers: SP1041
Study First Received: January 27, 2012
Results First Received: October 12, 2015
Last Updated: November 16, 2015
Health Authority: South Korea: Ministry of Food and Drug Safety (MFDS)