Bupropion and Restless Legs Syndrome | RxWiki

Bupropion and Restless Legs Syndrome

Overview[ - collapse ][ - ]

Purpose	The purpose of this study is to determine if bupropion will improve the symptoms of restless legs syndrome (RLS).
Condition	Restless Legs Syndrome
Intervention	Drug: Bupropion Drug: Placebo
Phase	Phase 2/Phase 3
Sponsor	East Tennessee State University
Responsible Party	East Tennessee State University
ClinicalTrials.gov Identifier	NCT00621517
First Received	February 12, 2008
Last Updated	April 4, 2012
Last verified	April 2012

Tracking Information[ + expand ][ + ]

First Received Date	February 12, 2008
Last Updated Date	April 4, 2012
Start Date	February 2008
Estimated Primary Completion Date	July 2009
Current Primary Outcome Measures	Change in International Restless Legs Syndrome Study Group (IRLSSG) Severity Scale. [Time Frame: Baseline, three weeks, and six weeks] [Designated as safety issue: No]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 [Time Frame: three weeks and six weeks] [Designated as safety issue: No] Ordinal Scale(i.e., 1-8)of Symptom Severity [Time Frame: three weeks and six weeks] [Designated as safety issue: No]
Current Secondary Outcome Measures	Not Provided

Descriptive Information[ + expand ][ + ]

Brief Title	Bupropion and Restless Legs Syndrome
Official Title	Bupropion and Restless Legs Syndrome
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.
Study Type	Interventional
Study Phase	Phase 2/Phase 3
Study Design	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Condition	Restless Legs Syndrome
Intervention	Drug: Bupropion Partipants will receive 150 mg bupropion per night Other Names: WellbutrinDrug: Placebo 1 capsule nightly for six weeks
Study Arm (s)	Experimental: 1 Participants will receive 150MG Bupropion nightly. Placebo Comparator: 2 Participants will receive matching placebo capsule nightly.

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	60
Estimated Completion Date	July 2009
Estimated Primary Completion Date	July 2009
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
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT00621517
Other Study ID Numbers	ETSU-07-061f
Has Data Monitoring Committee	No
Information Provided By	East Tennessee State University
Study Sponsor	East Tennessee State University
Collaborators	Not Provided
Investigators	Not Provided
Verification Date	April 2012

Locations[ + expand ][ + ]