Rare Patient Voice

This trial is not actively recruiting.

This trial has completed recruitment on this platform, and is no longer accepting new referrals.

It’s Uncomfortable, Disruptive, and Uncontrollable…it’s Possibly Symptoms of Restless Legs Syndrome (RLS)

Learn more about a 24-week Restless Legs study where you may participate from home.

Trial ID: NCT03728933

Trial Details

An at-home study for teenagers (13-17 years old) that explores whether an approved study drug currently approved for adults with Restless Legs Syndrome (RLS) is effective in treating RLS in adolescents. Participants will wear a transdermal patch daily for the duration of the study, use an app for visits with the study team and to complete surveys at the time of the study visit.

Estimated Enrollment

60 Participants

Phase

Eligibility Criteria

Participants must:

Be adolescents between 13-17 years of age
Have uncomfortable pain, tingling, or crawly agitation sensation in the legs or arms
Have an irresistible urge to move the legs
Be experiencing sensation that occurs or is worse in the evenings
Have their symptoms alleviated to some degree by movement
Have symptoms that impact their social life, school routine, energy and sleep

Participants must not:

Be pregnant or nursing
Have a known skin hypersensitivity to adhesives or other transdermal medications or has unresolved contact dermatitis or eczema.

This is a 24 week at home study where the participant must reside in one of the states below:

Alabama
Arizona
California
Colorado
Connecticut
Delaware
DC
Florida
Georgia
Iowa
Idaho
Illinois
Indiana
Kansas
Massachusetts
Maryland
Maine
Michigan
Minnesota
Missouri
Montana
Nebraska
Nevada
North Carolina
North Dakota
New Hampshire
New Jersey
New York
Ohio
Oklahoma
Pennsylvania
Rhode Island
South Carolina
South Dakota
Tennessee
Texas
Utah
Virginia
Vermont
Washington
Wisconsin
West Virginia
Wyoming

Frequently Asked Questions (FAQs)

Will I get paid to be a part of this clinical trial?

Yes, you will be paid for your time. We realize it takes a lot of time to come for study visits, so we want to make sure this is not too much of a burden for you. The study site will review all these details with you. Also, you do not have to pay anything to be in the study. All study related services are provided at no cost.

What is a placebo?

In order to understand if the study medication works, medical researchers are comparing the study medication to a placebo. A placebo looks like the study medication being tested but does not contain the study medication. All study volunteers will receive the same level of quality care regardless of if they are assigned to the study medication or the placebo.

How can I check to see if I’m eligible for this trial?

You can check if you are potentially eligible for this trial by completing a set of screening questions. You can find these on this web page by clicking the ‘Get Started’ button.

What does a typical research study look like?

Clinical trials help determine the safety and effectiveness of new treatments. A research plan or protocol is created that outlines how trial participants may receive interventions which can include investigational medications, devices, or procedures. The trial may compare a new medical approach to a standard treatment option already available, to a placebo with no active investigational medication, or to no intervention at all. The trial team will share more details before you participate.

Can I quit the trial at any time?

Study volunteers have the right to drop out of the study at any time for any reason, or no reason at all. The study doctor or sponsor also has the right to discontinue a study volunteer at any time for the participant’s safety, or if the participant no longer meets the study requirements.

What personal information is collected about you for the study?

The study doctor and other study staff will collect your personal information. This may include:

Your name, address, telephone number, health insurance number where applicable.
Your age, sex, ethnic and racial background.
Lifestyle information; health and medical history.
Your study treatments and response to study treatments.
Data resulting from testing your biological samples.

Who has access to your personal information?

All your personal information collected for this study will be securely stored in the study medical records at the study site. Sponsor staff, review boards and ethics committees (that approve and monitor studies), and others who have a need to know such as our data hosting provider, and government regulators may check the study records. This is done to make sure that the study is being run properly. Regulatory agencies, such as the US Food and Drug Administration (FDA), European Medicine Agency (EMA) or others, review and approve new medicines. These agencies will be granted direct access to your information. This is so they can verify clinical trial procedures and/or data. If you share your personal data to contact a site, that data will be used by TrialScope to contact you about clinical trials and related information.