Restless Legs Syndrome
Conditions
Keywords
Restless Legs Syndrome, Bupropion
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.
Interventions
DRUGBupropion
Partipants will receive 150 mg bupropion per night
DRUGPlacebo
1 capsule nightly for six weeks
Sponsors
East Tennessee State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bupropion Participants will receive 150MG Bupropion nightly. | 29 |
| Placebo Participants will receive matching placebo capsule nightly. | 31 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Lost to Follow-up | 3 | 3 |
| Overall Study | Withdrawal by Subject | 3 | 4 |
Baseline characteristics
| Characteristic | Placebo | Bupropion | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 2 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 27 Participants | 52 Participants |
| Age, Continuous | 50.5 years STANDARD_DEVIATION 14.1 | 48.0 years STANDARD_DEVIATION 12.9 | 49.3 years STANDARD_DEVIATION 13.5 |
| Region of Enrollment United States | 31 participants | 29 participants | 60 participants |
| Sex: Female, Male Female | 24 Participants | 22 Participants | 46 Participants |
| Sex: Female, Male Male | 7 Participants | 7 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 29 | 2 / 31 |
| serious Total, serious adverse events | 1 / 29 | 0 / 31 |
Outcome results
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.
Time frame: Baseline, three weeks, and six weeks
Population: Intention to Treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bupropion | Change in International Restless Legs Syndrome Study Group (IRLSSG) Severity Scale. | Change in IRLSSG score from baseline to 6 weeks | -10.4 points on a scale | Standard Deviation 10.1 |
| Bupropion | Change in International Restless Legs Syndrome Study Group (IRLSSG) Severity Scale. | Change in IRLSSG score from baseline to 3 weeks | -10.8 points on a scale | Standard Deviation 10 |
| Placebo | Change in International Restless Legs Syndrome Study Group (IRLSSG) Severity Scale. | Change in IRLSSG score from baseline to 6 weeks | -7.6 points on a scale | Standard Deviation 7.1 |
| Placebo | Change in International Restless Legs Syndrome Study Group (IRLSSG) Severity Scale. | Change in IRLSSG score from baseline to 3 weeks | -6.0 points on a scale | Standard Deviation 6.6 |
Primary
Clinical Global Impression - Improvement Scale
Time frame: three weeks and six weeks
Population: Once we started recruiting patients, we had decided not to do this outcome so this data was not obtained.
Primary
Ordinal Scale (i.e., 1-8) of Symptom Severity
Time frame: three weeks and six weeks
Population: Once we started recruiting patients, we had decided not to do this outcome so this data was not obtained.