Bupropion and Restless Legs Syndrome



Status:Completed
Conditions:Restless Leg Syndrome, Neurology
Therapuetic Areas:Neurology, Rheumatology
Healthy:No
Age Range:18 - Any
Updated:3/8/2019
Start Date:February 2008
End Date:July 2009

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The purpose of this study is to determine if bupropion will improve the symptoms of restless
legs syndrome (RLS).

Adult patients with moderate to severe RLS will be recruited for the study. Those on
medications which treat RLS will be asked to discontinue the medications for two weeks prior
to beginning the study. All participants will be screened with Beck Depression Inventory,
International Restless Legs Syndrome Study Group (IRLSSG) severity scale, and Clinical Global
Impression of Improvement (CGI-I) scale. An ordinal scale (i.e. rate symptoms from 1-8) will
also be obtained. Participants will be randomized to a placebo or medication group. Those in
the medication group will be given 150 mg of bupropion at night for six weeks. Others will
receive similar-appearing placebo. Participants will be called at the end of weeks one, two,
four and five to assess symptom severity based on IRLSSG scale, and to determine if they are
experiencing any adverse effects. At three weeks and six weeks, participants will return to
the clinic to complete all four of the initial forms, the Beck Depression Inventory, IRLSSG
severity scale, ordinal scale, and CGI-I.

Inclusion Criteria:

- clinical diagnosis of Restless Legs Syndrome

- Severity Scale score 15 or higher

Exclusion Criteria:

- History of seizures

- History of alcohol use greater than 2 drinks per day or occasional binges of 5 or more
drinks per day

- Suicidal thoughts/ideations

- Inability to return for follow up appointments at 3 and 6 weeks

- Lack of access to telephone

- Eating disorder

- Age less than 18

- Pregnancy

- Unwillingness or inability to discontinue any RLS medications
We found this trial at
1
site
Johnson City, Tennessee 37614
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Johnson City, TN
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