Suggested Immobilization Test (SIT) Test for Early Detection of Restless Legs Syndrome (RLS) Augmentation - Proof of Concept
Tracking Information | |||||
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First Received Date ICMJE | March 23, 2009 | ||||
Last Updated Date | August 13, 2012 | ||||
Start Date ICMJE | February 2009 | ||||
Primary Completion Date | July 2012 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
PLM on SIT tests [ Time Frame: 1, 2, 4, 6, 9 and 12 months ] [ Designated as safety issue: No ] | ||||
Change History | Complete list of historical versions of study NCT00867893 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE | |||||
Original Secondary Outcome Measures ICMJE | |||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Suggested Immobilization Test (SIT) Test for Early Detection of Restless Legs Syndrome (RLS) Augmentation - Proof of Concept | ||||
Official Title ICMJE | d Immobilization Test (SIT) Test for Early Detection of Restless Legs Syndrome (RLS) Augmentation - Proof of Concept | ||||
Brief Summary | Some medications used to treat the restless legs syndrome (RLS) when taken for some time make the condition worse. This study seeks to find a method for early detection of this problem so that it can either be prevented or corrected. |
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Detailed Description | Long term dopaminergic treatment of RLS produces an exacerbation of RLS symptoms worse than before treatment for a significant percentage (5 - 70%) of those treated. This appears to be related to half-life, dose and duration of treatment. Shorter half-life medications appear to produce more augmentation. Once started augmentation appears to be progressive in many of the patients with the end result that the patient has much more severe RLS symptoms than before treatment. These symptoms can still be temporarily reduced by adding more dopaminergic treatment, but eventually this fails to suffice even with very high dopaminergic doses. The problem is finding a way to detect augmentation early during dopamine treatment both to determine the true rate of occurrence of this problem and to change treatment strategies before the problem becomes severe. The suggested immobilization test creates the stimulus situation of protracted rest while lying down that provokes RLS symptoms. It provides a sensitive test for the severity of the symptom.. It should therefore provide an early detection of any exacerbation of symptoms such as that occurring with RLS augmentation. In addition diphenhydramine also creates an exacerbation of RLS symptoms. This exacerbation would amplify the current severity of the RLS and as such could provide a tool for enhancing the degree of augmentation. Thus testing with a diphenhydramine challenge dose before the SIT test could provide an even more sensitive measure of augmentation The investigators specifically hypothesize:
This study may for the first time provide a standard highly repeatable objective measure of RLS augmentation that is as or more sensitive as a very careful clinical evaluation by someone well trained in detecting RLS augmentation. As such it would prove clinically useful to evaluate RLS treatment progress. It would also provide an efficient method for evaluating the augmentation potential of new medications for RLS. . |
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Study Type ICMJE | Observational | ||||
Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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Biospecimen | |||||
Sampling Method | Non-Probability Sample | ||||
Study Population | RLS patients treated with medication |
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Condition ICMJE | Restless Legs Syndrome | ||||
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Study Group/Cohort (s) |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 68 | ||||
Completion Date | July 2012 | ||||
Primary Completion Date | July 2012 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00867893 | ||||
Other Study ID Numbers ICMJE | Sit-AUG | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Richard Allen, Johns Hopkins University | ||||
Study Sponsor ICMJE | Johns Hopkins University | ||||
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Investigators ICMJE |
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Information Provided By | Johns Hopkins University | ||||
Verification Date | August 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |