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Trial record 1 of 1 for:    NCT03728933
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A Study of Rotigotine Patch in Adolescent Subjects With Restless Legs Syndrome of Unknown Cause

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ClinicalTrials.gov Identifier: NCT03728933
Recruitment Status : Recruiting
First Posted : November 2, 2018
Last Update Posted : September 22, 2022
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma SRL )

Study Description
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Brief Summary:
The purpose of this study is to demonstrate the efficacy of rotigotine against placebo in adolescent subjects with idiopathic Restless Legs Syndrome (RLS) over a 12-week maintenance period and to investigate the safety and tolerability of rotigotine in adolescent subjects with idiopathic RLS.

Condition or disease Intervention/treatment Phase
Restless Legs Syndrome Drug: Rotigotine 1 milligram/24 hours Drug: Rotigotine 2 milligram/24 hours Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Remote, Double-Blind, Randomized, Placebo-Controlled Study of Rotigotine Transdermal System in Adolescent Subjects With Idiopathic Restless Legs Syndrome
Actual Study Start Date : December 20, 2018
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine

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

Arms and Interventions
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Arm Intervention/treatment
Experimental: 2 milligram/24 hours rotigotine
Subjects randomized to this arm will be initiated on 1 milligram (mg)/24 hours (h) rotigotine and up-titrated to a maximum of 2 mg/24 h rotigotine, which is the assigned dose level throughout the 12-week Maintenance Period.
 Drug: Rotigotine 1 milligram/24 hours
Pharmaceutical Form: transdermal patch Route of administration: transdermal use Concentration: Application of rotigotine transdermal patch with 1 milligram (mg)/24 hours (h) (5 square centimeter (cm^2) patch size).
Other Name: Neupro

Drug: Rotigotine 2 milligram/24 hours
Pharmaceutical Form: transdermal patch Route of administration: transdermal use Concentration: Application of rotigotine transdermal patch with 2 milligram (mg)/24 hours (h) (10 square centimeter (cm^2) patch size).
Other Name: Neupro
Experimental: 3 milligram/24 hours rotigotine
Subjects randomized to this arm will be initiated on 1 milligram (mg)/24 hours (h) rotigotine and up-titrated to a maximum of 3 mg/24 h rotigotine, which is the assigned dose level throughout the 12-week Maintenance Period.
 Drug: Rotigotine 1 milligram/24 hours
Pharmaceutical Form: transdermal patch Route of administration: transdermal use Concentration: Application of rotigotine transdermal patch with 1 milligram (mg)/24 hours (h) (5 square centimeter (cm^2) patch size).
Other Name: Neupro

Drug: Rotigotine 2 milligram/24 hours
Pharmaceutical Form: transdermal patch Route of administration: transdermal use Concentration: Application of rotigotine transdermal patch with 2 milligram (mg)/24 hours (h) (10 square centimeter (cm^2) patch size).
Other Name: Neupro
Placebo Comparator: Placebo
Subjects randomized to this arm will receive matching placebo patches to maintain the blinding.
 Drug: Placebo
Pharmaceutical Form: transdermal patch Route of administration: transdermal use Concentration: not applicable


Outcome Measures
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Primary Outcome Measures :
  1. Change from Baseline to the end of the Maintenance Period in International Restless Legs Rating Scale (IRLS) sum score [ Time Frame: From Baseline to the end of the Maintenance Period (Day 78) ]
    The sum score ranges from 0 (no RLS symptoms present) to 40 (maximum severity in all symptoms), which is the maximum score. A score between 31 and 40, indicates very severe RLS. A score between 21 and 30 indicates severe RLS. A score between 11 and 20 indicates moderate RLS. A score between 1 and 10 indicates mild RLS and a score of 0 means no RLS.

  2. Change from Baseline in Clinical Global Impressions (CGI) Item 1 to the end of the Maintenance Period [ Time Frame: From Baseline to the end of the Maintenance Period (Day 78) ]
    The Clinical Global Impressions Item 1 (Severity of Illness) score ranges from 0 to 7 as follows: 0=not assessed, 1=normal, not ill at all, 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill. The CGI Item 1 is to be completed during an interview between the subject and the investigator or designee.


Secondary Outcome Measures :
  1. Change from Baseline in Restless Legs-6 Rating Scales (RLS-6) to the end of the Maintenance Period [ Time Frame: From Baseline to the end of the Maintenance Period (Day 78) ]
    The RLS-6 Rating Scales is designed to assess the severity of RLS and consists of 6 subscales. The subscales assess severity of symptoms at the following times of the day/evening: falling asleep, during the night, during the day at rest, and during the day when engaged in daytime activities. In addition, the subscales assess satisfaction with sleep and severity of daytime tiredness/sleepiness.Scores for each of the 6 subscales range from 0 (completely satisfied) to 10 (completely dissatisfied).


Eligibility Criteria
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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is male or female, and is >=13 and <18 years of age at Baseline
  • Subject's Restless Legs Syndrome (RLS) symptoms cause significant daytime symptoms or significant distress or impairment in social, occupational, educational, or other important areas of functioning by the impact on sleep, energy/vitality, daily activities, behavior, cognition or mood
  • At Baseline, subject has a score of >=15 on the International Restless Legs Rating Scale (IRLS) (indicating moderate-to-severe RLS)
  • At Baseline, subject scores >=4 points on the Clinical Global Impressions (CGI) Item 1 assessment (indicating at least moderately ill)
  • If subject is receiving supplemental iron, subject has been on a stable dose for at least 3 months prior to Screening
  • Female subjects must be surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (oral/parenteral/implantable hormonal contraceptives, intrauterine device, or barrier and spermicide). Abstinence is an acceptable method. Subjects must agree to use adequate contraception during the study and for 4 weeks after their final dose of study medication.

Exclusion Criteria:

  • Subject has a serum ferritin level <50 ng/mL at Visit 1/Screening
  • Subject has a hemoglobin level below the lower limit of normal at Visit 1/Screening
  • Subject has had previous treatment with dopamine agonists or L-dopa within 7 days prior to Visit 2/Baseline
  • Subject has any medical or psychiatric condition, which in the opinion of the investigator, would jeopardize or compromise the subject's well-being or ability to participate in this study
  • Subject is pregnant or nursing
  • Subject is not willing to abstain from caffeine after 4 pm each evening within 7 days prior to Visit 2/Baseline and for the duration of the study
  • At Visit 1/Screening, subject has symptomatic orthostatic hypotension with a decrease of blood pressure (BP) from supine to standing position of >=20 mmHg in systolic blood pressure (SBP) or of >=10 mmHg in diastolic
Contacts and Locations
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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): NCT03728933


Contacts
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Contact: UCB Cares 001 844 599 2273 UCBCares@ucb.com

Locations
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United States, California
Sp1006 101 Recruiting
Culver City, California, United States, 90230
Sponsors and Collaborators
UCB Biopharma SRL
Investigators
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Study Director: UCB Cares 001 844 599 2273 (UCB)
More Information
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Responsible Party: UCB Biopharma SRL
ClinicalTrials.gov Identifier: NCT03728933    
Other Study ID Numbers: SP1006
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: September 22, 2022
Last Verified: September 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by UCB Pharma ( UCB Biopharma SRL ):
RLS
Rotigotine
Neupro
Additional relevant MeSH terms:
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Psychomotor Agitation
Restless Legs Syndrome
Syndrome
Disease
Pathologic Processes
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
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