Phase 3
N=60
Bupropion and Restless Legs Syndrome
Restless Legs Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00621517 ↗Enrolled (actual)
60
Serious AEs
1.7%
Results posted
Apr 2012
Primary outcome: Primary: Change in International Restless Legs Syndrome Study Group (IRLSSG) Severity Scale. — -10.4; -7.6; -10.8; -6.0 points on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Bupropion (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- East Tennessee State University
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in International Restless Legs Syndrome Study Group (IRLSSG) Severity Scale. |
-10.4; -7.6; -10.8; -6.0 | — |
| PRIMARY Clinical Global Impression - Improvement Scale |
— | — |
| PRIMARY Ordinal Scale (i.e., 1-8) of Symptom Severity |
— | — |
Summary
The purpose of this study is to determine if bupropion will improve the symptoms of restless legs syndrome (RLS).
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
Data sourced from ClinicalTrials.gov (NCT00621517). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.