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Sponsored by: |
Johns Hopkins University |
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Information provided by: | Johns Hopkins University |
ClinicalTrials.gov Identifier: | NCT00867893 |
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.
Condition |
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Restless Legs Syndrome |
Study Type: | Observational |
Study Design: | Case Control, Prospective |
Estimated Enrollment: | 60 |
Study Start Date: | February 2009 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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DA group
RLS patients started treatment on dopamine agonists within the past year
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NonDA
RLS patients started treatment on medication other than dopamine agonists within the past year
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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
We 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. .
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
RLS patients treated with medication
Inclusion Criteria:
One of the following 2 criteria must be met:
Exclusion Criteria:
History of major psychiatric or chronic neurological disorder that would affect RLS treatment or judgment.
These include but are not limited to bipolar depression, major affective disorder, schizophrenia, obsessive-compulsive disorder, and all neurodegenerative diseases.
Contact: Richard P Allen, PhD | 410-550-2609 | richardjhu@mac.com |
Contact: Christopher Earley, MD, PhD | 140-550-1044 | cearley@jhmi.edu |
United States, Maryland | |
Johns Hopkins Bayview Medical Center | Recruiting |
Baltimore, Maryland, United States, 21224 | |
Contact: Richard P Allen 410-550-2609 richardjhu@mac.com | |
Principal Investigator: Richard P Allen, PhD | |
Principal Investigator: Richard P P Allen, PhD |
Responsible Party: | Johns Hopkins University, School of Med, Dept of Neurology ( Richard P Allen, Ph.D. ) |
Study ID Numbers: | Sit-AUG |
Study First Received: | March 23, 2009 |
Last Updated: | March 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00867893 History of Changes |
Health Authority: | United States: Institutional Review Board |
Signs and Symptoms Mental Disorders Restless Legs Syndrome Neurologic Manifestations Dyssomnias |
Sleep Disorders Psychomotor Agitation Neurobehavioral Manifestations Dyskinesias Sleep Disorders, Intrinsic |
Disease Nervous System Diseases Parasomnias Dyssomnias Sleep Disorders Psychomotor Agitation Dyskinesias Sleep Disorders, Intrinsic |
Signs and Symptoms Pathologic Processes Mental Disorders Syndrome Restless Legs Syndrome Psychomotor Disorders Neurologic Manifestations Neurobehavioral Manifestations |