A randomised, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of ropinirole for 26 weeks and to further evaluate the incidence of augmentation and rebound for a further 40 weeks open-label extension treatment period in subjects suffering from moderate to severe Restless Legs Syndrome. - ND

• Conditions: Restless Legs Syndrome; MedDRA version: 6.1Level: PTClassification code 10058920

• Registration Number: EUCTR2005-005372-32-IT
• Lead Sponsor: GLAXO SMITHKLINE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05-09
• Last Update Posted: 1 May 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. Male and female subjects, 8805; 18 years and 80 years of age. A female is eligible to enter and participate in the study if she is of a. Non-childbearing potential i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal ; or, b. Childbearing potential, has a negative result on all required pregnancy tests prior to randomisation, and agrees to an acceptable contraceptive method as defined in Appendix 3. 2. Subjects with a diagnosis of idiopathic RLS using the RLS Diagnostic Clinical Interview and the International RLS Study Group IRLSSG Diagnostic Criteria during the Screening Visit Appendix 4 . 3. Subjects have had RLS symptoms with a history of a minimum of 15 RLS episodes during the previous month. If this is not possible due to the subject being on previous medication to treat RLS the investigator should ensure that the subject should have experienced 4-5 episodes of RLS symptoms during the last 7 days of the wash-out phase see below . 4. During the Wash-out and Screening Phase, RLS symptoms must be present for at least 4 of the last 7 nights immediately prior to the Baseline Visit. 5. Subjects with a total score 8805; 24 on the IRLS Rating Scale at baseline Day 0 see Appendix 5 . 6. Subjects with RLS symptoms that cause significant sleep impairment based on clinical judgment and guided by subject response to Question 4 of the IRLS Rating Scale at the Baseline Visit OR RLS symptoms that cause severe/very severe discomfort in the limbs based on clinical judgment and guided by subject response to Question 1 of the IRLS Rating Scale at the Baseline Visit Day 0 . 7. Subjects must be experiencing RLS symptoms requiring treatment at night-time. 8. Subjects must have given written informed consent prior to any specific study procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Subjects suffering from augmentation and/ or end of treatment rebound RLS symptoms at baseline Day 0 . 2. Subjects with a previous history of augmentation. 3. Subjects who have exhibited intolerance to ropinirole or any other dopamine agonist. 4. Subjects requiring treatment of daytime RLS symptoms daytime defined as 10 00 hours until 17 00 hours . 5. Signs of secondary RLS 6. Subjects with a serum ferritin level of 10 mcg/L ng/mL at Screening Visit. 7. Subjects who suffer from a primary sleep disorder other than RLS that may significantly affect the symptoms of RLS 8. Subjects diagnosed with movement disorders e.g., Parkinson s Disease, dyskinesias, and dystonias . 9. Subjects who have medical conditions which could affect efficacy assessments or clinically significant or unstable medical conditions that present a safety concern. 10. Subjects having a clinically significant abnormal laboratory value, ECG, or physical examination findings not resolved by the time of the baseline examinations Day 0 . 11. Subjects with a diastolic blood pressure 8805; 110mmHg or 8804; 50mmHg or systolic blood pressure 8805; 180mmHg or 8804; 90mmHg at the Screening or Baseline Visit. 12. Subjects with a history of alcohol or substance abuse within the past year. 13. Subjects taking any medication known to induce drowsiness, affect RLS or sleep and which have not been discontinued prior to the Baseline Visit. 14. Withdrawal, introduction, or change in dose of hormone replacement therapy HRT and/or any drug known to substantially inhibit CYP1A2 or induce CYP1A2 within 7 days prior to enrolment. 15. Night workers or any others whose sleeping habits are incompatible with the study design, or who would be required to make significant changes to their bed time

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified