Bupropion and Restless Legs Syndrome - Tabular View

Tracking Information
First Received Date ^ICMJE	February 12, 2008
Last Updated Date	October 1, 2009
Start Date ^ICMJE	February 2008
Primary Completion Date	July 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 21, 2008)	Change in International Restless Legs Syndrome Study Group severity scale [ Time Frame: weekly for six weeks ] [ Designated as safety issue: No ] 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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00621517 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Bupropion and Restless Legs Syndrome
Official Title ^ICMJE	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 Phase	Phase II, Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Condition ^ICMJE	Restless Legs Syndrome
Intervention ^ICMJE	Drug: Bupropion Drug: Placebo
Study Arms / Comparison Groups	Active Comparator: Participants will receive 150MG Bupropion nightly. Placebo Comparator: Participants will receive matching placebo capsule nightly.
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	70
Completion Date	July 2009
Primary Completion Date	July 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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 and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00621517
Responsible Party	Max Bayard, M.D., Principal Investigator, East Tennessee State University
Study ID Numbers ^ICMJE	ETSU-07-061f
Study Sponsor ^ICMJE	East Tennessee State University
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	East Tennessee State University
Verification Date	October 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP