Rotigotine 2 milligram/24 hours for Restless Legs Syndrome

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Restless Legs Syndrome+2 More
Rotigotine 2 milligram/24 hours - Drug
Eligibility
< 18
All Sexes
What conditions do you have?
Select

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

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

2 Primary · 1 Secondary · Reporting Duration: From Baseline to the end of the Maintenance Period (Day 78)

Day 78
Change from Baseline in Clinical Global Impressions (CGI) Item 1 to the end of the Maintenance Period
Change from Baseline in Restless Legs-6 Rating Scales (RLS-6) 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

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

3 Treatment Groups

2 milligram/24 hours rotigotine
1 of 3
3 milligram/24 hours rotigotine
1 of 3
Placebo
1 of 3

Experimental Treatment

Non-Treatment Group

138 Total Participants · 3 Treatment Groups

Primary Treatment: Rotigotine 2 milligram/24 hours · Has Placebo Group · Phase 3

2 milligram/24 hours rotigotineExperimental Group · 2 Interventions: Rotigotine 2 milligram/24 hours, Rotigotine 1 milligram/24 hours · Intervention Types: Drug, Drug
3 milligram/24 hours rotigotineExperimental Group · 2 Interventions: Rotigotine 2 milligram/24 hours, Rotigotine 1 milligram/24 hours · Intervention Types: Drug, Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from baseline to the end of the maintenance period (day 78)

Who is running the clinical trial?

UCB Biopharma SRLLead Sponsor
82 Previous Clinical Trials
20,526 Total Patients Enrolled
1 Trials studying Restless Legs Syndrome
138 Patients Enrolled for Restless Legs Syndrome
UCB Biopharma S.P.R.L.Lead Sponsor
71 Previous Clinical Trials
11,967 Total Patients Enrolled
1 Trials studying Restless Legs Syndrome
138 Patients Enrolled for Restless Legs Syndrome
UCB CaresStudy Director001 844 599 2273 (UCB)
185 Previous Clinical Trials
43,312 Total Patients Enrolled
1 Trials studying Restless Legs Syndrome
138 Patients Enrolled for Restless Legs Syndrome

Eligibility Criteria

Age < 18 · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are male or female, and are 13 or older at Baseline.
You have a score of 4 or more on the Clinical Global Impressions (CGI) Item 1 assessment.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 17th, 2021

Last Reviewed: November 11th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.