Bupropion and Restless Legs Syndrome

Restless Legs Syndrome Clinical Trial

Official title:

Bupropion and Restless Legs Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00621517
• Other study ID #: ETSU-07-061f
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: February 2008
• Est. completion date: July 2009

Study information

• Verified date: February 2019
• Source: East Tennessee State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Psychomotor Agitation
• Restless Legs Syndrome
• Syndrome

Intervention

Drug:
• Bupropion
Partipants will receive 150 mg bupropion per night
• Placebo
1 capsule nightly for six weeks

Locations

Country	Name	City	State
United States	East Tennessee State University	Johnson City	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
East Tennessee State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in International Restless Legs Syndrome Study Group (IRLSSG) Severity Scale.	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.	Baseline, three weeks, and six weeks
Primary	Clinical Global Impression - Improvement Scale		three weeks and six weeks
Primary	Ordinal Scale (i.e., 1-8) of Symptom Severity		three weeks and six weeks