Status:
COMPLETED
Long-Term Follow-Up Study for Safety, Efficacy and Tolerability of Rotigotine in Adolescents With Restless Legs Syndrome
Lead Sponsor:
UCB BIOSCIENCES, Inc.
Conditions:
Restless Legs Syndrome
Eligibility:
All Genders
13+ years
Phase:
PHASE2
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...
Detailed Description
Study design was changed and an amendment was prepared accordingly.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01498120
Start Date
December 1 2011
End Date
December 1 2015
Last Update
August 1 2017
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
012
Los Angeles, California, United States
2
009
Orange, California, United States
3
014
Spring Hill, Florida, United States
4
013
Indianapolis, Indiana, United States