Suggested Immobilization Test (SIT) Test for Early Detection of Restless Legs Syndrome (RLS) Augmentation - Proof of Concept
Completed
Conditions studied: Restless Legs Syndrome
In brief
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.
Key facts
- Study ID
- NCT00867893
- Run by
- Johns Hopkins University
- People needed
- 68
- Starts
- 2009-02-01
- Expected to finish
- 2012-07-01
- Last updated by the study team
- 2012-08-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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