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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES, Inc. )
ClinicalTrials.gov Identifier:
NCT01498120
First received: December 16, 2011
Last updated: October 18, 2016
Last verified: October 2016
  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:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • Number of Subjects Withdrawn Due to An Adverse Event (AE) From Visit 1 (Day 1) Through End of Study [ Time Frame: Visit 1 (Day 1) through End of Study (approximately 2 years) ] [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: No ]
    An Adverse Event is any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.

  • Number of Subjects With 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: No ]
    An Adverse Event is any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.


Enrollment: 14
Study Start Date: December 2011
Study Completion Date: December 2015
Primary Completion Date: December 2015 (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   (Child, Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
012
Los Angeles, California, United States
009
Orange, California, United States
United States, Florida
014
Spring Hill, Florida, United States
United States, Indiana
013
Indianapolis, Indiana, United States
United States, Louisiana
001
Destrehan, Louisiana, United States
Sponsors and Collaborators
UCB BIOSCIENCES, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center 1-877-822-9493 (UCB)
  More Information

Responsible Party: UCB BIOSCIENCES, Inc.
ClinicalTrials.gov Identifier: NCT01498120     History of Changes
Other Study ID Numbers: SP1005 
Study First Received: December 16, 2011
Results First Received: August 1, 2016
Last Updated: October 18, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by UCB Pharma:
Rotigotine
Restless Legs Syndrome
RLS
Long-term
Adolescents

Additional relevant MeSH terms:
Syndrome
Psychomotor Agitation
Restless Legs Syndrome
Disease
Pathologic Processes
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Parasomnias
Mental Disorders
N 0437
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 07, 2016