Bupropion and Restless Legs Syndrome
1 other identifier
interventional
60
1 country
1
Brief Summary
The purpose of this study is to determine if bupropion will improve the symptoms of restless legs syndrome (RLS).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2008
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 12, 2008
CompletedFirst Posted
Study publicly available on registry
February 22, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedResults Posted
Study results publicly available
April 5, 2012
CompletedMarch 6, 2019
February 1, 2019
1.4 years
February 12, 2008
March 4, 2012
February 14, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Clinical Global Impression - Improvement Scale
three weeks and six weeks
Ordinal Scale (i.e., 1-8) of Symptom Severity
three weeks and six weeks
Study Arms (2)
1
EXPERIMENTALParticipants will receive 150MG Bupropion nightly.
2
PLACEBO COMPARATORParticipants will receive matching placebo capsule nightly.
Interventions
Eligibility Criteria
You may qualify if:
- clinical diagnosis of Restless Legs Syndrome
- Severity Scale score 15 or higher
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
East Tennessee State University
Johnson City, Tennessee, 37614, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Possible Type II error as we were unable to recruit our target of 100 participants.
Results Point of Contact
- Title
- Max Bayard MD
- Organization
- East Tennessee State University
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Family Medicine
Study Record Dates
First Submitted
February 12, 2008
First Posted
February 22, 2008
Study Start
February 1, 2008
Primary Completion
July 1, 2009
Study Completion
July 1, 2009
Last Updated
March 6, 2019
Results First Posted
April 5, 2012
Record last verified: 2019-02