ong-Term Follow-Up Study for Safety, Efficacy and Tolerability of Rotigotine in Adolescents With Restless Legs Syndrome

Conditions: Restless Legs Syndrome
MedDRA version: 18.1Level: PTClassification code 10058920Term: Restless legs syndromeSystem Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2016-000635-40-Outside-EU/EEA

Lead Sponsor: CB BIOSCIENCES, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 24

Inclusion Criteria

• Tolerated the first dose level of Rotigotine in a previous study in adolescents with Restless Legs Syndrome (RLS), without meeting withdrawal criteria
• Is expected to benefit from participation, in the opinion of the investigator
• Subject/legal representative is considered reliable and capable of adhering to the protocol, visit schedule, and study patch application/removal, according to the judgment of the investigator
Are the trial subjects under 18? yes
Number of subjects for this age range: 24
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

Exclusion Criteria

• Previously participated in this study
• Is experiencing an ongoing serious adverse event (SAE) that is assessed to be related to Rotigotine by the investigator or sponsor
• Pregnant or nursing or is a female of childbearing potential who is not surgically sterile or does not consistently use 2 combined medically acceptable methods of birth control (including at least 1 barrier method), unless not sexually active
• Any medical or psychiatric condition that, in the opinion of the investigator, can jeopardize or would compromise the subject's ability to participate
• Active suicidal ideation as indicated by a positive response (Yes) to either Question 4 or Question 5 of the Since the Last Visit version of the Columbia Suicide Severity Rating Scale (C-SSRS) of the final evaluation visit of the previous Rotigotine study

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to assess the long-term safety and tolerability of rotigotine treatment in adolescents with idiopathic restless legs syndrome (RLS).;Secondary Objective: The secondary objective of this study is to assess the long-term efficacy of rotigotine treatment in adolescents with idiopathic restless legs syndrome (RLS).;Primary end point(s): - Withdrawal Due to An Adverse Event (AE) From Visit 1 (Day 1) Through End of Study<br>- Occurrence of At Least One Adverse Event (AE) From Visit 1 (Day 1) to End of Study;Timepoint(s) of evaluation of this end point: Visit 1 (Day 1) through End ofStudy (approximately 2 years)

Secondary Outcome Measures