RL0007
RL0007
A Remote, Open-Label, Long-Term, Follow-up Study to Determine the Safety, Tolerability, and Efficacy of Rotigotine Transdermal System as Monotherapy in Adolescents with Restless Legs Syndrome
Brief summary
The purpose of this study is to assess the long-term safety, tolerability and the long-term efficacy of rotigotine treatment in adolescents with idiopathic Restless Legs Syndrome (RLS).
Medical Condition
Restless Legs Syndrome
Min. Age
13
Years
Max. Age
17
Years
Who Can Join?
All
Status
Enrolling by invitation
Inclusion criteria
- Subject weighs >=40 kg - Subject has completed at least one dose step in SP1006, 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
Exclusion criteria
- 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 electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at the final evaluation visit of the previous rotigotine study (ie, Visit 10 of SP1006)
Study Medication Description
Study Medication:
Neupro®
Other Descriptive Name:
rotigotine
Placebo
No
Comparator:
No
Refer to a friend
Study Dates
December 2019
Actual Start Date of Enrollment
October 2024
Planned Study Completion Date