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Completed

NCT Number: NCT00621517

Bupropion and Restless Legs Syndrome

The purpose of this study is to determine if bupropion will improve the symptoms of restless legs syndrome (RLS).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

East Tennessee State University

Johnson City, Tennessee, 37614, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bupropion

Drug

Partipants will receive 150 mg bupropion per night

Other names: Wellbutrin

Placebo

Drug

1 capsule nightly for six weeks

Primary outcomes

  1. Change in International Restless Legs Syndrome Study Group (IRLSSG) Severity Scale.

    Time frame: 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.

  2. Clinical Global Impression - Improvement Scale

    Time frame: three weeks and six weeks

  3. Ordinal Scale (i.e., 1-8) of Symptom Severity

    Time frame: three weeks and six weeks

Sponsors and collaborators

Lead sponsor

East Tennessee State University

Other

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Feb 22, 2008
Registry last updated
Mar 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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