A Study of Rotigotine Patch in Adolescent Subjects With Restless Legs Syndrome of Unknown Cause

Last updated: October 5, 2023
Sponsor: UCB Biopharma SRL
Overall Status: Terminated

Phase

3

Condition

Dyskinesias

Manic Disorders

Williams Syndrome

Treatment

Placebo

Rotigotine 1 milligram/24 hours

Rotigotine 2 milligram/24 hours

Clinical Study ID

NCT03728933
SP1006
  • Ages 13-17
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 orsignificant distress or impairment in social, occupational, educational, or otherimportant areas of functioning by the impact on sleep, energy/vitality, dailyactivities, behavior, cognition or mood
  • At Baseline, subject has a score of >=15 on the International Restless Legs RatingScale (IRLS) (indicating moderate-to-severe RLS)
  • At Baseline, subject scores >=4 points on the Clinical Global Impressions (CGI) Item 1assessment (indicating at least moderately ill)
  • Subjects who are receiving supplemental iron have been on a stable dose for at least 1month prior to Screening
  • Female subjects must be surgically incapable of childbearing, or effectivelypracticing an acceptable method of contraception (oral/parenteral/implantable hormonalcontraceptives, intrauterine device, or barrier and spermicide). Abstinence is anacceptable method. Subjects must agree to use adequate contraception during the studyand for 4 weeks after their final dose of study medication.

Exclusion

Exclusion Criteria:

  • Subject has a serum ferritin level below the lower limit of normal 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 daysprior to Visit 2/Baseline
  • Subject has any medical or psychiatric condition, which in the opinion of theinvestigator, would jeopardize or compromise the subject's well-being or ability toparticipate in this study
  • Subject is pregnant or nursing
  • Subject is not willing to abstain from caffeine after 4 pm each evening within 7 daysprior to Visit 2/Baseline and for the duration of the study
  • At Visit 1/Screening, subject has symptomatic orthostatic hypotension with a decreaseof blood pressure (BP) from supine to standing position of >=20 mmHg in systolic bloodpressure (SBP) or of >=10 mmHg in diastolic
  • Subject has secondary Restless Legs Syndrome (RLS) (eg, due to renal insufficiency [uremia], iron deficiency, or rheumatoid arthritis)
  • Subject has a lifetime history of suicide attempts (including actual attempt,interrupted attempt, or aborted attempt), or had suicidal ideation in the past 6months as indicated by a positive response ("Yes") to either Question 4 or Question 5of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening (Visit 1)
  • Subject is taking a prohibited concomitant medication. Prohibited concomitantmedication must have been discontinued at least 2 weeks prior to Screening (Visit 1)

Study Design

Total Participants: 23
Treatment Group(s): 3
Primary Treatment: Placebo
Phase: 3
Study Start date:
December 20, 2018
Estimated Completion Date:
July 25, 2022

Connect with a study center

  • Sp1006 101

    Culver City, California 90230
    United States

    Site Not Available

  • Sp1006 101

    Los Angeles, California 90094
    United States

    Site Not Available

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