Trial Outcomes & Findings for Bupropion and Restless Legs Syndrome (NCT NCT00621517)

NCT ID: NCT00621517

Last Updated: 2019-03-06

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 60 participants
• Primary outcome timeframe: Baseline, three weeks, and six weeks
• Results posted on: 2019-03-06

Participant Flow

Participant milestones

Measure	Bupropion Participants will receive 150MG Bupropion nightly.	Placebo Participants will receive matching placebo capsule nightly.
Overall Study STARTED	29	31
Overall Study COMPLETED	22	24
Overall Study NOT COMPLETED	7	7

Reasons for withdrawal

Measure	Bupropion Participants will receive 150MG Bupropion nightly.	Placebo Participants will receive matching placebo capsule nightly.
Overall Study Lost to Follow-up	3	3
Overall Study Withdrawal by Subject	3	4
Overall Study Adverse Event	1	0

Baseline Characteristics

Bupropion and Restless Legs Syndrome

Baseline characteristics by cohort

Measure	Bupropion n=29 Participants Participants will receive 150MG Bupropion nightly.	Placebo n=31 Participants Participants will receive matching placebo capsule nightly.	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=5 Participants	25 Participants n=7 Participants	52 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants
Age, Continuous	48.0 years STANDARD_DEVIATION 12.9 • n=5 Participants	50.5 years STANDARD_DEVIATION 14.1 • n=7 Participants	49.3 years STANDARD_DEVIATION 13.5 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	24 Participants n=7 Participants	46 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Region of Enrollment United States	29 participants n=5 Participants	31 participants n=7 Participants	60 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, three weeks, and six weeks

Population: Intention to Treat

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.

Outcome measures

Measure	Bupropion n=29 Participants Participants will receive 150MG Bupropion nightly.	Placebo n=31 Participants Participants will receive matching placebo capsule nightly.
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	-7.6 points on a scale Standard Deviation 7.1
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 10.0	-6.0 points on a scale Standard Deviation 6.6

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

Adverse Events

Bupropion

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Bupropion n=29 participants at risk Participants will receive 150MG Bupropion nightly.	Placebo n=31 participants at risk Participants will receive matching placebo capsule nightly.
Pregnancy, puerperium and perinatal conditions miscarriage	4.5% 1/22	0.00% 0/24

Other adverse events

Measure	Bupropion n=29 participants at risk Participants will receive 150MG Bupropion nightly.	Placebo n=31 participants at risk Participants will receive matching placebo capsule nightly.
Gastrointestinal disorders nausea	3.4% 1/29 • Number of events 1	6.5% 2/31 • Number of events 2

Additional Information

Max Bayard MD

East Tennessee State University

Phone: 802-524-8805

Email: mmbayard3@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place