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

Purpose

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.

Condition	Intervention	Phase
Restless Legs Syndrome	Drug: Rotigotine	Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: Restless Legs

Drug Information available for: Rotigotine

U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:

Withdrawal Due to An Adverse Event (AE) From Visit 1 (Day 1) Through End of Study [ Time Frame: Visit 1 (Day 1) through End of Study (approximately 2 years) ] [ Designated as safety issue: Yes ]
An Adverse Event is any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Occurrence of At Least One Adverse Event (AE) From Visit 1 (Day 1) to End of Study [ Time Frame: From Visit 1 (Day 1) through End of Study (approximately 2 years) ] [ Designated as safety issue: Yes ]
An Adverse Event is any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.

Estimated Enrollment:	24
Study Start Date:	December 2011
Estimated Study Completion Date:	June 2021
Estimated Primary Completion Date:	June 2021 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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)	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

Detailed Description:

Study design was changed and an amendment was prepared accordingly.

Eligibility

Ages Eligible for Study:	13 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01498120

Contacts

Contact: UCB Clinical Trial Call Center

1-877-822-9493

Locations

United States, Arkansas
006	Recruiting
Little Rock, Arkansas, United States
United States, California
012	Completed
Los Angeles, California, United States
009	Recruiting
Orange, California, United States
010	Withdrawn
San Diego, California, United States
United States, District of Columbia
005	Recruiting
Washington, District of Columbia, United States
United States, Florida
014	Recruiting
Spring Hill, Florida, United States
United States, Indiana
013	Recruiting
Indianapolis, Indiana, United States
United States, Louisiana
001	Recruiting
Destrehan, Louisiana, United States
United States, Missouri
015	Recruiting
Saint Louis, Missouri, United States
United States, New York
007	Recruiting
West Seneca, New York, United States
United States, Ohio
002	Recruiting
Cincinnati, Ohio, United States
United States, Pennsylvania
016	Recruiting
West Chester, Pennsylvania, United States
United States, Texas
003	Recruiting
Austin, Texas, United States

Sponsors and Collaborators

UCB BIOSCIENCES, Inc.

Investigators

Study Director:

UCB Clinical Trial Call Center

1-877-822-9493 (UCB)

More Information

No publications provided

Responsible Party:	UCB, Inc. ( UCB BIOSCIENCES, Inc. )
ClinicalTrials.gov Identifier:	NCT01498120 History of Changes
Other Study ID Numbers:	SP1005
Study First Received:	December 16, 2011
Last Updated:	May 13, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by UCB, Inc.:

Rotigotine
Restless Legs Syndrome
RLS
Long-term
Adolescents

Additional relevant MeSH terms:

Restless Legs Syndrome
Psychomotor Agitation
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Parasomnias
Mental Disorders
Dyskinesias
Neurologic Manifestations

Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
N 0437
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013