Overview

A Follow-up Study of Rotigotine Patch in Adolescent Subjects With Restless Legs Syndrome

Status:
Enrolling by invitation
Trial end date:
2024-10-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
UCB Biopharma S.P.R.L.
Treatments:
Rotigotine
Criteria
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)