A follow-up study of rotigotine patch in adolescent subjects with Restless Legs Syndrome
- Conditions
- Restless Legs Syndrome (RLS)Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2021-003403-18-Outside-EU/EEA
- Lead Sponsor
- CB Biopharma SR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- Not specified
- Subject weighs >=40 kg
- Subject has completed at least one dose step in SP1006 [NCT03728933], a previous study of rotigotine in adolescents with Restless Legs Syndrome (RLS), without meeting withdrawal criteria
- Female subjects must be surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (oral/parenteral/implantable hormonal contraceptives, intrauterine device, or barrier and spermicide). Abstinence is an acceptable method. Subjects must agree to use adequate contraception during the study and for 4 weeks after their final dose of study drug
- Subject is expected to benefit from participation, in the opinion of the investigator
Are the trial subjects under 18? yes
Number of subjects for this age range: 138
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
- Subject is experiencing an ongoing serious Adverse Event (SAE) that is assessed to be related to rotigotine by the investigator or Sponsor
- Subject has active suicidal ideation as indicated by a positive response (Yes”) to either Question 4 or Question 5 of the Since Last Visit” version of the Columbia-Suicide Severity Rating Scale (C-SSRS) at the final evaluation visit of the previous rotigotine study (ie, Visit 9 of SP1006)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the long-term safety and tolerability of rotigotine treatment in adolescents with idiopathic Restless Legs Syndrome (RLS);Secondary Objective: To assess the long-term efficacy of rotigotine treatment in adolescents with idiopathic Restless Legs Syndrome (RLS);Primary end point(s): 1. Occurence of treatment-emergent adverse events (TEAEs)<br>2. Treatment-emergent adverse events leading to permanent withdrawal of study medication;Timepoint(s) of evaluation of this end point: 1.; 2. From Study Entry until the Safety Follow-Up Visit (up to 14 Months)
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Changes from Baseline in International Restless Legs Rating Scale (IRLS) sum score at Visit 9<br>2. Changes from Baseline in Clinical Global Impressions (CGI) Item 1 at Visit 9<br>3. Changes from Baseline in Restless Legs-6 Rating Scales (RLS-6) at Visit 9;Timepoint(s) of evaluation of this end point: 1. - 3. From Baseline to Visit 9 (up to 13 Months)