Status:
COMPLETED
Suggested Immobilization Test (SIT) Test for Early Detection of Restless Legs Syndrome (RLS) Augmentation - Proof of Concept
Lead Sponsor:
Johns Hopkins University
Conditions:
Restless Legs Syndrome
Eligibility:
All Genders
18+ years
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 ...
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...
Eligibility Criteria
Inclusion
- Primary RLS (exclude all secondary RLS including those related to neuropathies and medications)
- Adult and adolescents 18 years of age or older
- One of the following 2 criteria must be met:
- RLS treatment with either ropinirole or pramipexole or with a non-DA treatment (opioid or GABA active hypnotic), with the first dose each day taken at or before 4:30 PM. (Note this allows patients to be entered who had the usual tapered withdrawal from another medication with a concurrent gradual start of the DA agonist or opioid over a period of up to 12 months. In all such cases the initial evaluations must occur at least 6 weeks after discontinuing any prior drug treatment.) OR
- Off all RLS medication treatments for at least 6 weeks AND planning on starting DA agonist or a non-DA treatment (opioid or GABA active hypnotic) as the only RLS medication treatment.
Exclusion
- Pregnant or lactating.
- Inadequate birth control if female and able to become pregnant.
- History of allergic reaction to diphenhydramine.
- 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.
- History of another major sleep disorder other than RLS and insomnia: narcolepsy, significant sleep-disordered breathing (DBR\>15/hr), and circadian rhythm disorder.
- History of use of dopamine antagonist within the last year for any reason other than treating nausea.
- History of use of tramadol within the last 3 months.
- Unable to give informed consent.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT00867893
Start Date
February 1 2009
End Date
July 1 2012
Last Update
August 14 2012
Active Locations (1)
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1
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224