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

Phase 2

Completed

• Conditions: Restless Legs Syndrome
• Interventions: Drug: Rotigotine

• Registration Number: NCT01498120
• Lead Sponsor: UCB BIOSCIENCES, Inc.

Brief Summary

This is a Phase 2, multicenter, open-label, single-arm, optimal dose, long-term follow-up study of monotherapy administration of rotigotine transdermal patch in adolescents with Restless Legs Syndrome (RLS). This study will assess the long-term safety and tolerability of Rotigotine treatment in adolescents with RLS.

Detailed Description

Study design was changed and an amendment was prepared accordingly.

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2011-12-16
• Study First Submitted QC: 2011-12-20
• Study First Posted: 2011-12-23
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Results First Submitted: 2016-08-01
• Results First Submitted QC: 2016-08-01
• Results First Posted: 2016-09-21
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-06
• Last Update Posted: 2017-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

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
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rotigotine	Rotigotine	Optimal dose after titration period 0.5 mg/24 h (2.5 cm\^2)- 1 mg/24 h (5 cm\^2)- 2 mg/24 h (10 cm\^2)- 3 mg/24 h (15 cm\^2)

Primary Outcome Measures

Name	Time	Method
Number of Subjects Withdrawn Due to An Adverse Event (AE) From Visit 1 (Day 1) Through End of Study	Visit 1 (Day 1) through End of Study (approximately 2 years)	An Adverse Event is any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Number of Subjects With At Least One Adverse Event (AE) From Visit 1 (Day 1) to End of Study	From Visit 1 (Day 1) through End of Study (approximately 2 years)	An Adverse Event is any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.

Trial Locations

Locations (5)

012; 🇺🇸 Los Angeles, California, United States

001; 🇺🇸 Destrehan, Louisiana, United States

013; 🇺🇸 Indianapolis, Indiana, United States

014; 🇺🇸 Spring Hill, Florida, United States

009; 🇺🇸 Orange, California, United States