ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01498120
Recruitment Status : Completed
First Posted : December 23, 2011
Results First Posted : September 21, 2016
Last Update Posted : August 1, 2017
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES, Inc. )

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.

Condition or disease Intervention/treatment Phase
Restless Legs Syndrome Drug: Rotigotine Phase 2

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : December 2011
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Restless Legs
Drug Information available for: Rotigotine

Arm Intervention/treatment
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





Primary Outcome Measures :
  1. Number of Subjects Withdrawn Due to An Adverse Event (AE) From Visit 1 (Day 1) Through End of Study [ Time Frame: Visit 1 (Day 1) through End of Study (approximately 2 years) ]
    An Adverse Event is any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.

  2. 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) ]
    An Adverse Event is any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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)

Additional Information:
Responsible Party: UCB BIOSCIENCES, Inc.
ClinicalTrials.gov Identifier: NCT01498120     History of Changes
Other Study ID Numbers: SP1005
First Posted: December 23, 2011    Key Record Dates
Results First Posted: September 21, 2016
Last Update Posted: August 1, 2017
Last Verified: July 2017

Keywords provided by UCB Pharma ( UCB BIOSCIENCES, Inc. ):
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
Rotigotine
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs