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A follow-up study of rotigotine patch in adolescent subjects with Restless Legs Syndrome

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

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2021-003403-18-Outside-EU/EEA
Enrollment
Unknown
Registered
2023-09-18
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Restless Legs Syndrome (RLS)

Interventions

Trade Name: Neupro Product Name: Neupro 1 mg/24 h transdermal patch Pharmaceutical Form: Transdermal patch INN or Proposed INN: Rotigotine CAS Number: 99755-59-6 Concentration unit: mg milligram(s) Co

Sponsors

UCB Biopharma SRL
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - 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

Exclusion criteria

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 Columbia-Suicide Severity Rating Scale (C-SSRS) at the final evaluation visit of the previous rotigotine study (ie, Visit 9 of SP1006)

Design outcomes

Primary

MeasureTime frame
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) 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

MeasureTime frame
Secondary end point(s): 1. Changes from Baseline in International Restless Legs Rating Scale (IRLS) sum score at Visit 9 2. Changes from Baseline in Clinical Global Impressions (CGI) Item 1 at Visit 9 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)—

Countries

United States

Contacts

Public ContactClin Trial Reg & Results Disclosure

UCB Biosciences GmbH

clinicaltrials@ucb.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026