WithdrawnPhase 4

Butrans for Treatment of Restless Legs Syndrome

Stopped: No funding

United States0Started 2014-04

Plain-language summary

The primary objective of the study is to determine whether Butrans Transdermal System (BTDS) reduces RLS symptom severity in patients with moderate to severe idiopathic RLS who are naïve to opiate treatment. The secondary objective of the study is to investigate the effects of BTDS on mood, sleep, and quality of life. The study will consist of nine visits. Depending on the need for medication titration, there may also be two scheduled telephone contacts. Visit 1: This is a screening visit to determine study eligibility. Eligible subjects who choose to participate must undergo medication washout as described in the detailed protocol between visits 1 and 2. Treatment period #1 (Visits 2 - 5; day 0 - 28): Baseline measures will be recorded and subjects randomized to treatment order at visit 2 (day 0). Study medication as well as rescue medication (l-dopa, a non-blinded active treatment to be used within a limited dose range as described in the detailed protocol) will be dispensed. Subjects will begin treatment period #1 immediately after this. The study medication will be titrated within the allowed range according to subject's reported symptoms during visit 3 (day 7), visit 4 (day 14), telephone contact (day 21). Visit 5 will occur on day 28 and will include assessment of outcome measures for the first treatment period. Visit 5 will also mark the beginning of the second treatment period. Treatment period #2 (Visits 6 - 8; day 28 - 56): Procedures will be similar to those described above during treatment period #1. Visit 8 will mark the end of the second treatment period during which outcome measures will be ascertained. Follow up visit (Visit 9; day 70): This will be a safety follow-up visit approximately two weeks after visit 8 for review of adverse events.

Who can participate

Age range25 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subject has a diagnosis of RLS, defined by International Restless Legs Study Group (IRLS) essential criteria: * An urge to move the legs, usually accompanied or caused by uncomfortable and unpleasant sensations in the legs. * The urge to move or unpleasant sensations begin or worsen during periods of rest or inactivity such as lying down or sitting. * The urge to move or unpleasant sensations are partially or totally relieved by movement, such as walking or stretching, at least as long as the activity continues. * The urge to move or unpleasant sensations are worse in the evening or night than during the day or only occur in the evening or night. * Subject has moderate to severe RLS symptoms,defined as an International Restless Legs Scale (IRLS) score greater than or equal to15 at the baseline visit (visit 2). * Subject has RLS symptoms that, in the opinion of the investigator, require round-the-clock treatment. * Subject speaks and reads English. * Subject is able to provide informed consent. * Subject is age ≥25 and ≤75. * Subject has BMI ≥18 and ≤35 * Subject is naïve to opioid treatment, defined as subjects not having received ≥5 mg oxycodone in the past 14 days and no history of daily use of ≥5 mg oxycodone equivalents in the past 3 months. * If subject is currently being treated for RLS, s/he must have an inadequate response to or be intolerant of current, non-opioid regimen. * If subject is not currently being treated for RLS, s/he must …

What they're measuring

The International Restless Legs Scale (IRLS)

Timeframe: Within subjects IRLS score change after 4 weeks on placebo vs 4 weeks on BTDS

Trial details

NCT IDNCT02138357

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-12