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



Status:Completed
Conditions:Restless Leg Syndrome, Neurology
Therapuetic Areas:Neurology, Rheumatology
Healthy:No
Age Range:13 - Any
Updated:4/21/2016
Start Date:December 2011
End Date:December 2015

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An 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

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.

Study design was changed and an amendment was prepared accordingly.

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
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