Bupropion and Restless Legs Syndrome
Primary Purpose
Restless Legs Syndrome
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bupropion
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Restless Legs Syndrome focused on measuring Restless Legs Syndrome, Bupropion
Eligibility Criteria
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
Sites / Locations
- East Tennessee State University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Participants will receive 150MG Bupropion nightly.
Participants will receive matching placebo capsule nightly.
Outcomes
Primary Outcome Measures
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.
Clinical Global Impression - Improvement Scale
Ordinal Scale (i.e., 1-8) of Symptom Severity
Secondary Outcome Measures
Full Information
NCT ID
NCT00621517
First Posted
February 12, 2008
Last Updated
February 14, 2019
Sponsor
East Tennessee State University
1. Study Identification
Unique Protocol Identification Number
NCT00621517
Brief Title
Bupropion and Restless Legs Syndrome
Official Title
Bupropion and Restless Legs Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
East Tennessee State University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Restless Legs Syndrome
Keywords
Restless Legs Syndrome, Bupropion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive 150MG Bupropion nightly.
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Participants will receive matching placebo capsule nightly.
Intervention Type
Drug
Intervention Name(s)
Bupropion
Other Intervention Name(s)
Wellbutrin
Intervention Description
Partipants will receive 150 mg bupropion per night
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
1 capsule nightly for six weeks
Primary Outcome Measure Information:
Title
Change in International Restless Legs Syndrome Study Group (IRLSSG) Severity Scale.
Description
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.
Time Frame
Baseline, three weeks, and six weeks
Title
Clinical Global Impression - Improvement Scale
Time Frame
three weeks and six weeks
Title
Ordinal Scale (i.e., 1-8) of Symptom Severity
Time Frame
three weeks and six weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
East Tennessee State University
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37614
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Bupropion and Restless Legs Syndrome
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