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

NCT03728933 | Terminated Phase 3 Results FDA Drug

• 1 other identifier: SP1006
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Restless Legs Syndrome

Keywords

RLS; Rotigotine; Neupro

Outcome Measures

Primary Outcomes (4)

• Change From Baseline to the End of the Maintenance Period in International Restless Legs Rating Scale (IRLS) Sum Score

  The IRLS consisted of 10 questions, each scored using a 5-point scale ranging from 0=not present to 4=very severe. The IRLS sum score was calculated by summing up the single scores of all applicable questions, i.e., the total sum score ranged from 0 (no RLS symptoms present) to 40 (maximum severity in all symptoms). 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. A negative change from Baseline indicates improvement.

  From Baseline to the end of the Maintenance Period (Day 106)

• Change From Baseline in Clinical Global Impressions (CGI) Item 1 to the End of the Maintenance Period

  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 was completed during an interview between the participant and the investigator or designee. A negative change from Baseline indicates improvement.

  From Baseline to the end of the Maintenance Period (Day 106)

• Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)

  TEAEs were defined as events that started during the Treatment Period or within 30 days following the end of the Treatment Period (i.e., on or after the date of first patch application and within 30 days following the date of last patch removal + 1 day), or those events where the intensity worsened within this time frame.

  From Baseline to Safety Follow-Up (up to Week 20)

• Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawals

  TEAEs were defined as events that started during the Treatment Period or within 30 days following the end of the Treatment Period (i.e., on or after the date of first patch application and within 30 days following the date of last patch removal + 1 day), or those events where the intensity worsened within this time frame.

  From Baseline to Safety Follow-Up (up to Week 20)

Secondary Outcomes (1)

• Change From Baseline in Restless Legs-6 Rating Scales (RLS-6) to the End of the Maintenance Period

  From Baseline to the end of the Maintenance Period (Day 106)

Study Arms (3)

2 milligram/24 hours rotigotine

EXPERIMENTAL

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; Drug: Rotigotine 2 milligram/24 hours

3 milligram/24 hours rotigotine

EXPERIMENTAL

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 (1 mg/24 h patch + 2 mg/24 patch at the same time), which is the assigned dose level throughout the 12-week Maintenance Period.

Drug: Rotigotine 1 milligram/24 hours; Drug: Rotigotine 2 milligram/24 hours

Placebo

PLACEBO COMPARATOR

Subjects randomized to this arm will receive matching placebo patches to maintain the blinding.

Drug: Placebo

Interventions

Rotigotine 1 milligram/24 hours DRUG

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).

Also known as: Neupro

2 milligram/24 hours rotigotine; 3 milligram/24 hours rotigotine

Rotigotine 2 milligram/24 hours DRUG

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).

Also known as: Neupro

2 milligram/24 hours rotigotine; 3 milligram/24 hours rotigotine

Placebo DRUG

Pharmaceutical Form: transdermal patch Route of administration: transdermal use Concentration: not applicable

Placebo

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)
• Subjects who are receiving supplemental iron have been on a stable dose for at least 1 month 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.

You may not qualify if:

• 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 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
• 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 6 months as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening (Visit 1)
• Subject is taking a prohibited concomitant medication. Prohibited concomitant medication must have been discontinued at least 2 weeks prior to Screening (Visit 1)

Sponsors & Collaborators

• UCB Biopharma SRL: lead

Study Sites (1)

Sp1006 101

Culver City, California, 90230, United States

Location

MeSH Terms

Conditions

Restless Legs Syndrome

Interventions

rotigotine

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Results Point of Contact

• Title: UCB
• Organization: Cares

UCBCares@ucb.com

001 844 599 2273

Study Officials

• UCB Cares

  001 844 599 2273

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2018
• First Posted: November 2, 2018
• Study Start: December 20, 2018
• Primary Completion: July 25, 2022
• Study Completion: July 25, 2022
• Last Updated: October 26, 2023
• Results First Posted: October 26, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
• Access Criteria: Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed.All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.

Locations

US (1)