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 |
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 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
We found this trial at
5
sites
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