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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01498120
Other study ID # SP1005
Secondary ID
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


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
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