Phase 2
N=14
Long-Term Follow-Up Study for Safety, Efficacy and Tolerability of Rotigotine in Adolescents With Restless Legs Syndrome
Restless Legs Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01498120 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Sep 2016
Primary outcome: Primary: Number of Subjects Withdrawn Due to An Adverse Event (AE) From Visit 1 (Day 1) Through End of Study — 3 subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Rotigotine (Drug)
- Age
- Pediatric, Adult, Older Adult · 13+ yrs
- Sex
- All
- Sponsor
- UCB BIOSCIENCES, Inc.
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Withdrawn Due to An Adverse Event (AE) From Visit 1 (Day 1) Through End of Study |
3 | — |
| PRIMARY Number of Subjects With At Least One Adverse Event (AE) From Visit 1 (Day 1) to End of Study |
10 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01498120). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.