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

Restless Legs Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01498120
• Other study ID #: SP1005
• Status: Completed
• Phase: Phase 2
• First received: December 16, 2011
• Last updated: February 9, 2016
• Start date: December 2011
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

Study design was changed and an amendment was prepared accordingly.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psychomotor Agitation
• Restless Legs Syndrome
• Syndrome

Intervention

Drug:
• Rotigotine
Optimal dose after titration period 0.5 mg/24 h (2.5 cm^2)- 1 mg/24 h (5 cm^2)- 2 mg/24 h (10 cm^2)- 3 mg/24 h (15 cm^2) 1 patch /day

Locations

Country	Name	City	State
United States	001	Destrehan	Louisiana
United States	013	Indianapolis	Indiana
United States	012	Los Angeles	California
United States	009	Orange	California
United States	014	Spring Hill	Florida

Sponsors (1)

Lead Sponsor	Collaborator
UCB BIOSCIENCES, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Withdrawal Due to An Adverse Event (AE) From Visit 1 (Day 1) Through End of Study	An Adverse Event is any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.	Visit 1 (Day 1) through End of Study (approximately 2 years)	Yes
Primary	Occurrence of At Least One Adverse Event (AE) From Visit 1 (Day 1) to End of Study	An Adverse Event is any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.	From Visit 1 (Day 1) through End of Study (approximately 2 years)	Yes