Efficacy, Safety and Tolerability of Rotigotine Nasal Spray for the Acute Treatment of RLS Symptoms

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00389831
First received: October 17, 2006
Last updated: August 30, 2011
Last verified: February 2011
Results First Received: July 28, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Restless Legs Syndrome
Interventions: Drug: Rotigotine Nasal Spray
Other: Placebo Nasal Spray

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo Subjects receiving a single dose of placebo nasal spray on all 4 treatment days
Rotigotine Nasal Spray Subjects receiving doses of placebo nasal spray on Day 1 or Day 2, Rotigotine nasal spray 62µg on Day 1 or Day 2, Rotigotine nasal spray 124µg on Day 3, and Rotigotine nasal spray 247µg on Day 4

Participant Flow:   Overall Study
    Placebo     Rotigotine Nasal Spray  
STARTED     10     34  
COMPLETED     10     27  
NOT COMPLETED     0     7  
Lack of Efficacy                 0                 2  
Did not receive treatment.                 0                 2  
Other reasons                 0                 2  
Lost to Follow-up                 0                 1  



  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 Subjects receiving a single dose of placebo nasal spray on all 4 treatment days
Rotigotine Nasal Spray Subjects receiving doses of placebo nasal spray on Day 1 or Day 2, Rotigotine nasal spray 62µg on Day 1 or Day 2, Rotigotine nasal spray 124µg on Day 3, and Rotigotine nasal spray 247µg on Day 4
Total Total of all reporting groups

Baseline Measures
    Placebo     Rotigotine Nasal Spray     Total  
Number of Participants  
[units: participants]
  10     34     44  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     9     33     42  
>=65 years     1     1     2  
Age  
[units: years]
Mean ± Standard Deviation
  55.5  ± 5.40     52.9  ± 7.78     53.5  ± 7.33  
Gender  
[units: participants]
     
Female     8     21     29  
Male     2     13     15  
Region of Enrollment  
[units: participants]
     
Germany     10     34     44  



  Outcome Measures
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1.  Primary:   Average Numeric Symptom Severity Score After Single Dose of Rotigotine Nasal Spray or Matching Placebo   [ Time Frame: 4 hours post-treatment period at each treatment day ]

2.  Primary:   Average PLMWI (Periodic Leg Movement Index During Wakefulness) After Single Dose of Rotigotine Nasal Spray or Matching Placebo.   [ Time Frame: 4 hours post-treatment period at each treatment day ]


  Serious Adverse Events


  Other Adverse Events


  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.


Limitations and Caveats
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.  


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


No publications provided


Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT00389831     History of Changes
Other Study ID Numbers: SP879
Study First Received: October 17, 2006
Results First Received: July 28, 2009
Last Updated: August 30, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices