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Dopamine Agonist

Rotigotine 1 milligram/24 hours for Restless Legs Syndrome

Phase 3
Waitlist Available
Research Sponsored by UCB Biopharma S.P.R.L.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to the end of the maintenance period (day 106)
Awards & highlights

Study Summary

This trial will show if the drug Rotigotine is effective against Restless Legs Syndrome in adolescents, as well as investigating if it is safe to use.

Eligible Conditions
  • Restless Legs Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to the end of the maintenance period (day 106)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to the end of the maintenance period (day 106) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline in Clinical Global Impressions (CGI) Item 1 to the End of the Maintenance Period
Change From Baseline to the End of the Maintenance Period in International Restless Legs Rating Scale (IRLS) Sum Score
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
+1 more
Secondary outcome measures
Change From Baseline in Restless Legs-6 Rating Scales (RLS-6) to the End of the Maintenance Period

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: 3 milligram/24 hours rotigotineExperimental Treatment2 Interventions
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.
Group II: 2 milligram/24 hours rotigotineExperimental Treatment2 Interventions
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.
Group III: PlaceboPlacebo Group1 Intervention
Subjects randomized to this arm will receive matching placebo patches to maintain the blinding.

Find a Location

Who is running the clinical trial?

UCB Biopharma S.P.R.L.Lead Sponsor
71 Previous Clinical Trials
11,781 Total Patients Enrolled
1 Trials studying Restless Legs Syndrome
10 Patients Enrolled for Restless Legs Syndrome
UCB Biopharma SRLLead Sponsor
101 Previous Clinical Trials
21,413 Total Patients Enrolled
1 Trials studying Restless Legs Syndrome
10 Patients Enrolled for Restless Legs Syndrome
UCB CaresStudy Director001 844 599 2273
205 Previous Clinical Trials
44,940 Total Patients Enrolled
1 Trials studying Restless Legs Syndrome
10 Patients Enrolled for Restless Legs Syndrome

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you please share what other similar medical studies have been done using Rotigotine 2 milligram/24 hours?

"There are 4 ongoing clinical trials researching Rotigotine 2 milligram/24 hours. Of those 4, 2 have progressed to Phase 3. Most of the research facilities for this medication are in Culver City, California, however, there are 9 different sites running these trials."

Answered by AI

Are there any documented side effects of Rotigotine 2 milligram/24 hours?

"Rotigotine 2 milligram/24 hours is a Phase 3 trial medication, meaning that while there is some data supporting efficacy, there is extensive data supporting safety. Our team at Power gave it a score of 3."

Answered by AI

Does this trial have an age limit? If so, what is it?

"In order to be eligible for this clinical trial, patients must be aged between 13 to 17 years old. Out of the 1,440 total studies, this age group makes up for 391 of them."

Answered by AI

For which patient population is this trial designed?

"This clinical trial is recruiting 138 patients, between the ages of 13 and 17 who currently have restless legs syndrome. It is important that participants also meet the following criteria:Subject is male or female, and is >=13 and <18 years of age at Baseline, At Baseline, subject scores >=4 points on the Clinical Global Impressions (CGI) Item 1 assessment (indicating at least moderately ill), 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/v"

Answered by AI

Are there any more patients being accepted for this trial period?

"The clinical trial is currently looking for participants and was originally posted on December 20th, 2018 with the last edit on September 19th, 2022."

Answered by AI

How many people have been chosen to participate in this experiment?

"Yes, this is an ongoing study that is still recruiting patients. The listing on clinicaltrials.gov shows that the trial was first posted on December 20, 2018 and last updated September 19, 2022. The study is looking for 138 participants across 1 location."

Answered by AI

Have other researchers looked into this before?

"Presently, 4 ongoing clinical trials for Rotigotine 2 milligram/24 hours are being conducted in 5 separate cities and 2 different nations. The first of these trials began in 2016 and was completed in the same year. This trial, which was sponsored by Serina Therapeutics, only required 20 participants and it successfully completed Phase 1 of drug approval. Since that time, a total of 18,289 clinical trials have been completed."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of Rotigotine Patch in Adolescent Subjects With Restless Legs Syndrome of Unknown Cause
2018. "A Study of Rotigotine Patch in Adolescent Subjects With Restless Legs Syndrome of Unknown Cause". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03728933.
~4 spots leftby Apr 2025
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