Clinical Trials Logo
  1. Home
  2. Restless Legs Syndrome
  3. NCT02138357

Butrans for Treatment of Restless Legs Syndrome — Butrans  

Restless Legs Syndrome Clinical Trial

Official title:
Butrans for Treatment of Restless Legs Syndrome

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02138357
Study type Interventional
Source Massachusetts General Hospital
Contact
Status Withdrawn
Phase Phase 4
Start date April 2014
Completion date December 2016
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT04786314 - The Effect of Hot and Cold Water Application on Pregnant Women With Restless Leg Syndrome N/A
Completed NCT01455012 - Effects of Neupro on Cardiovascular Observations in Patients With Restless Legs Syndrome Phase 4
Terminated NCT01192503 - Safety and Efficacy of Rasagiline in Restless Legs Syndrome Phase 2/Phase 3
Completed NCT00530530 - ASP8825 - Study in Patients With Restless Legs Syndrome Phase 2
Completed NCT00721279 - Sifrol (Pramipexole) Onset of Action and Impact: a 12-weeks Observational Study in Patients With Primary Restless Legs Syndrome N/A
Completed NCT00942253 - Exercise Training in Dialysis Patients With Restless Legs Syndrome (RLS) Phase 2
Completed NCT00375284 - A 6 Week Trial to Study the Efficacy and Safety of a Starting Dose 0.25 mg Pramipexole (Mirapex) in Patients With RLS Phase 4
Completed NCT00479531 - Sequential Compression Devices for Treatment of Restless Legs Syndrome Phase 3
Recruiting NCT05581576 - Pitolisant in Refractory Restless Legs Syndrome Phase 4
Active, not recruiting NCT03218969 - Treatment of Restless Leg Syndrome (RLS) Augmentation With Ecopipam, a D1 Specific Antagonist Phase 1/Phase 2
Recruiting NCT04144790 - Impact of Iron Supplementation Treatment on Brain Iron Concentrations
Completed NCT05787080 - Massage, Oxidative and Antioxidant Enzymes in Hemodialysis Patients With Restless Legs Syndrome(RLS) N/A
Not yet recruiting NCT05529095 - Sublingual Apomorphine in Refractory Restless Legs Syndrome Phase 4
Recruiting NCT05044520 - Clinical Features Associated With Restless Legs Syndrome.
Withdrawn NCT03849001 - Impact of Acute Leg Cycling at Various Intensities on RLS Severity in Persons With MS N/A
Completed NCT03076541 - Cardiovascular Variability, Heart Rate Response, and Electromyogram Power Associated With Periodic Leg Movements. N/A
Recruiting NCT04145674 - A Proof of Concept, Phase 2, Double-blind, Randomized Trial With d-Methadone Product Versus Placebo Phase 2
Completed NCT02532608 - Infra-slow Oscillations During Sleep N/A
Completed NCT01528462 - Sleep Disorders Managed and Assessed Rapidly in Transient Ischemic Attack (TIA) and In Early Stroke
Completed NCT00748098 - Polysomnography Study of GSK1838262 Extended Release Tablets Versus Placebo in RLS and Associated Sleep Disturbance Phase 3