← Back to Search

Dopamine Agonist

Rotigotine 2 mg/24 h 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
Subject is expected to benefit from participation, in the opinion of the investigator
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up visit 9 (month 12), compared to baseline (in sp1006)
Awards & highlights

Study Summary

This trial will study the long-term effects of a drug called rotigotine on teens with a condition called restless legs syndrome.

Eligible Conditions
  • Restless Legs Syndrome

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
The study doctor thinks that you will benefit from being in the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~visit 9 (month 12), compared to baseline (in sp1006)
This trial's timeline: 3 weeks for screening, Varies for treatment, and visit 9 (month 12), compared to baseline (in sp1006) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal of Study Medication
Secondary outcome measures
Changes From Baseline in Clinical Global Impressions (CGI) Item 1 at Visit 9
Changes From Baseline in International Restless Legs Rating Scale (IRLS) Sum Score at Visit 9
Changes From Baseline in Restless Legs-6 Rating Scales (RLS-6) at Visit 9

Trial Design

1Treatment groups
Experimental Treatment
Group I: RotigotineExperimental Treatment3 Interventions
Subjects will be initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 3 mg/24 h rotigotine, with the aim of achieving the individually optimized dosage. Dose adjustment of rotigotine is allowed at any time during the following Maintenance Period up to a maximum dose of 3 mg/24 h. At the end of the Maintenance Period, subjects will be down-titrated.

Find a Location

Who is running the clinical trial?

UCB Biopharma S.P.R.L.Lead Sponsor
71 Previous Clinical Trials
11,794 Total Patients Enrolled
1 Trials studying Restless Legs Syndrome
23 Patients Enrolled for Restless Legs Syndrome
UCB Biopharma SRLLead Sponsor
99 Previous Clinical Trials
21,237 Total Patients Enrolled
1 Trials studying Restless Legs Syndrome
23 Patients Enrolled for Restless Legs Syndrome
UCB CaresStudy Director001 844 599 2273
203 Previous Clinical Trials
44,352 Total Patients Enrolled
1 Trials studying Restless Legs Syndrome
23 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.

Can octogenarians be given this therapy?

"According to the age requirements for this study, teenagers aged 13 to 17 are eligible to enroll."

Answered by AI

What are the risks associated with taking Rotigotine 2 mg/24 h?

"There is some evidence from previous clinical trials to support the efficacy of Rotigotine 2 mg/24 h, and it has thus been given a score of 3 for safety."

Answered by AI

Are there vacancies in this research for participants?

"The clinicaltrials.gov site says that this specific study is not looking for participants at the moment. The trial was initially posted on December 3rd, 2019 but was most recently updated on September 19th, 2020. However, there are over 1,400 other trials that are recruiting patients right now."

Answered by AI

Is the Rotigotine 2 mg/24 h drug regimen unique to this study?

"There are 4 clinical studies underway involving Rotigotine 2 mg/24 h. Of these, 2 are in Phase 3. Despite the majority of research being based in Culver City, California, there are trials happening in 9 different locations."

Answered by AI

Are there other similar ongoing projects like this one?

"There have been a total of 66 clinical trials for Rotigotine 2 mg/24 h since 2016, with 4 active studies currently taking place across 5 cities in 2 countries."

Answered by AI

How many people are the most that can take part in this research?

"Although this particular trial is not currently looking for more participants, it is important to note that there are 4 trials for Rotigotine 2 mg/24 h that are actively enrolling participants. Additionally, 1481 studies are actively looking for participants with restless legs syndrome."

Answered by AI

Could you walk me through the prerequisites for joining this particular experiment?

"This clinical trial is testing the effects of rotigotine on 138 adolescents with restless legs syndrome. To be eligible, patients must meet the following criteria: female subjects must be surgically incapable of childbearing or using an effective method of contraception (oral/parenteral/implantable hormonal contraceptives, intrauterine device, or barrier and spermicide), subjects must agree to use adequate contraception during the study and for 4 weeks after their final dose of study drug, subject weighs >=40 kg, and subject has completed at least one dose step in SP1006, a previous study of rotigotine in adolescents with restless legs syndrome"

Answered by AI
~2 spots leftby Mar 2025