NCT00621517

Bupropion and Restless Legs Syndrome

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: East Tennessee State University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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.

Conditions

• Restless Legs Syndrome

Interventions

Type	Name	Description
DRUG	Bupropion	Partipants will receive 150 mg bupropion per night
DRUG	Placebo	1 capsule nightly for six weeks

Timeline

• Start date: 2008-02-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2008-02-22
• Last updated: 2019-03-06
• Results posted: 2012-04-05

Locations

1 site across 1 country: United States