Long-Term Follow-Up Study for Safety, Efficacy and Tolerability of Rotigotine in Adolescents With Restless Legs Syndrome
Completed · Phase 2
Conditions studied: Restless Legs Syndrome
In brief
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.
Key facts
- Study ID
- NCT01498120
- Run by
- UCB BIOSCIENCES, Inc.
- People needed
- 14
- Starts
- 2011-12-01
- Expected to finish
- 2015-12-01
- Last updated by the study team
- 2017-08-01
Who can join
Age: 13 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- 012 — Los Angeles, California, United States
- 009 — Orange, California, United States
- 014 — Spring Hill, Florida, United States
- 013 — Indianapolis, Indiana, United States
- 001 — Destrehan, Louisiana, United States
Full record on ClinicalTrials.gov
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