Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2026-03-01 @ 4:45 PM
Study NCT ID:
NCT00867893
Status:
COMPLETED
Last Update Posted:
2012-08-14
First Post:
2009-03-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Suggested Immobilization Test (SIT) Test for Early Detection of Restless Legs Syndrome (RLS) Augmentation - Proof of Concept
Sponsor:
Johns Hopkins University
Organization:
Study Overview
Official Title:
d Immobilization Test (SIT) Test for Early Detection of Restless Legs Syndrome (RLS) Augmentation - Proof of Concept
Status:
COMPLETED
Status Verified Date:
2012-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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:
1. The objective measures from the SIT test will reveal an increase in severity of RLS that occurs with RLS augmentation at the same time or before the augmentation is detected by the usual subjective clinical assessments.
2. An oral dose of 25 mg of diphenhydramine taken 45 minutes before a SIT test will amplify the augmentation effects shown on the objective measures of the SIT. This will provide an enhanced detection of augmentation before or at the same time as that detected by either the SIT test alone or the clinical evaluation.
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. .
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:
1. The objective measures from the SIT test will reveal an increase in severity of RLS that occurs with RLS augmentation at the same time or before the augmentation is detected by the usual subjective clinical assessments.
2. An oral dose of 25 mg of diphenhydramine taken 45 minutes before a SIT test will amplify the augmentation effects shown on the objective measures of the SIT. This will provide an enhanced detection of augmentation before or at the same time as that detected by either the SIT test alone or the clinical evaluation.
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. .
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: