Official Title: “Bupropion and Restless Legs Syndrome”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: June 2008

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.

Intervention(s) in this Clinical Trial

• Drug: Bupropion
  • 150 MG per day for six weeks
• Drug: Placebo
  • 1 capsule nightly for six weeks

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Participants will receive 150MG Bupropion nightly.
• Placebo Comparator: 2
  • Participants will receive matching placebo capsule nightly.

Primary Measures

• Change in International Restless Legs Syndrome Study Group severity scale
  • Time Frame: weekly for six weeks
    Safety Issue?: No
• Clinical Global Impression - Improvement Scale
  • Time Frame: three weeks and six weeks
    Safety Issue?: No
• Ordinal Scale(i.e., 1-8)of symptom severity
  • Time Frame: three weeks and six weeks
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: East Tennessee State University

Overall Clinical Trial Officials and Contacts

Overall Contact: Max Bayard, M.D. 423 439-6471 bayard@etsu.edu

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00621517

Study ID Number: ETSU-07-061f

ClinicalTrials.gov Identifier: NCT00621517

Health Authority: United States: Institutional Review Board