Bupropion and Restless Legs Syndrome

Phase 2

Completed

• Conditions: Restless Legs Syndrome
• Interventions: Drug: Bupropion; Drug: Placebo

• Registration Number: NCT00621517
• Lead Sponsor: East Tennessee State University

Brief 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.

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-02-12
• Study First Submitted QC: 2008-02-21
• Study First Posted: 2008-02-22
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Results First Submitted: 2012-03-04
• Results First Submitted QC: 2012-04-04
• Results First Posted: 2012-04-05
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-14
• Last Update Posted: 2019-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Bupropion	Participants will receive 150MG Bupropion nightly.
2	Placebo	Participants will receive matching placebo capsule nightly.

Primary Outcome Measures

Name	Time	Method
Change in International Restless Legs Syndrome Study Group (IRLSSG) Severity Scale.	Baseline, three weeks, and six weeks	Scale ranges from 0 to 40 points with higher scores being associated with more severe symptoms of restless legs syndrome. There are 10 questions, with points of 0 to 4 per question. The change in IRLSSG score from baseline is recorded at three and six weeks.
Clinical Global Impression - Improvement Scale	three weeks and six weeks
Ordinal Scale (i.e., 1-8) of Symptom Severity	three weeks and six weeks

Trial Locations

Locations (1)

East Tennessee State University; 🇺🇸 Johnson City, Tennessee, United States