Clinical trial NCT01498120: Long-Term Follow-Up Study for Safety, Efficacy and Tolerability of Rotigotine in Adolescents With Restless Legs Syndrome
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Restless Legs Syndrome
Keywords: Rotigotine
Restless Legs Syndrome
RLS
Long-term
Adolescents
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2011-12-23
Enrollment: 14
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 (RLS). This study will assess the long-term safety and tolerability of Rotigotine treatment in adolescents with RLS.

Detailed description: Study design was changed and an amendment was prepared accordingly.

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

Primary outcomes:
measure: Number of Subjects Withdrawn Due to An Adverse Event (AE) From Visit 1 (Day 1) Through End of Study
timeFrame: Visit 1 (Day 1) through End of Study (approximately 2 years)
measure: Number of Subjects With At Least One Adverse Event (AE) From Visit 1 (Day 1) to End of Study
timeFrame: From Visit 1 (Day 1) through End of Study (approximately 2 years)
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: 012
state: California
city: Orange
country: United States
facility: 009
state: California
city: Spring Hill
country: United States
facility: 014
state: Florida
city: Indianapolis
country: United States
facility: 013
state: Indiana
city: Destrehan
country: United States
facility: 001
state: Louisiana
Study officials:
affiliation: 1-877-822-9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: