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Botulinum Toxin to Treat Restless Legs Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fatta Nahab, National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00479154
First received: May 25, 2007
Last updated: April 25, 2012
Last verified: April 2012
History of Changes
Results First Received: March 14, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Restless Legs Syndrome
Intervention: Drug: Botulinum Toxin A

  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
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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 Then Botulinum Toxin Injection into set of leg muscles with Placebo followed by crossover to Botulinum Toxin (90 mU per leg) at week 6.
Botulinum Toxin Then Placebo Injection of Botulinum Toxin (90 mU per leg) followed by crossover to placebo at week 6.

Participant Flow:   Overall Study
    Placebo Then Botulinum Toxin     Botulinum Toxin Then Placebo  
STARTED     3     3  
COMPLETED     3     3  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Placebo Then Botulinum Toxin Injection into set of leg muscles with Placebo followed by crossover to Botulinum Toxin (90 mU per leg) at week 6.
Botulinum Toxin Then Placebo Injection of Botulinum Toxin (90 mU per leg) followed by crossover to placebo at week 6.
Total Total of all reporting groups

Baseline Measures
    Placebo Then Botulinum Toxin     Botulinum Toxin Then Placebo     Total  
Number of Participants  
[units: participants]
 		  3     3     6  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     3     3     6  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  53.7  ± 11.8     61.7  ± 2.5     57.7  ± 8.8  
Gender  
[units: participants]
 		     
Female     2     2     4  
Male     1     1     2  
Region of Enrollment  
[units: participants]
 		     
United States     3     3     6  



  Outcome Measures

1.  Primary:   Change in Restless Legs Syndrome Rating Scale   [ Time Frame: Week 2 and Week 4 for each intervention (vs. baseline) ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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
N/A  


Results Point of Contact:  
Name/Title: Fatta Nahab
Organization: NINDS/NIH
phone: 301-496-9526
e-mail: nahabf@ninds.nih.gov


Publications:


Responsible Party: Fatta Nahab, National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00479154     History of Changes
Other Study ID Numbers: 070160, 07-N-0160
Study First Received: May 25, 2007
Results First Received: March 14, 2011
Last Updated: April 25, 2012
Health Authority: United States: Federal Government