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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

Study Dates

December 2019

Actual Start Date of Enrollment

October 2024

Planned Study Completion Date

General Information

Study ID:
RL0007
CT.gov Number:
NCT03992196
Phase:
Phase 3

Interested in enrolling in our study?

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