Are you suffering from Restless Legs Syndrome?
You may be eligible to participate in a clinical study for an investigational treatment option.
You may be eligible for the RESTFUL study if:
**This is not a complete list and other eligibility criteria may apply
The purpose of this study is to determine the effectiveness and safety of a wearable device for RLS symptoms in adults who have not responded fully to RLS medication(s).
In this 8-week clinical trial, you will test an investigational treatment option for managing the symptoms of RLS based on a wearable study device instead of a medication.
If you may be eligible, a patient outreach representative will call you, provide additional details about the study, and further evaluate your eligibility.
The study team will determine if you are eligible to participate in the study; if you qualify and decide to participate, you will be enrolled in the study.
Throughout the 8-week study duration, you will:
Enter your information to express interest in the study.
Research studies are designed in specific ways to test the study drug or safety and effectiveness. One or more of the answers that you provided were outside of the guidelines for this trial. This does not mean you will not qualify for different research studies.
You will be assigned active study treatment for at least 4-weeks. There is a 50% chance you will be assigned active study treatment for all 8-weeks and a 50% chance you will be assigned active study treatment for 4-weeks and placebo study treatment for 4-weeks.
There are 6 sites in the USA.
At the beginning of the study, you will receive training on how to use the study device at home. You will also receive follow-up instructions and training throughout the study.
The study device delivers low-intensity stimulation to the nerves of the legs. It is worn on both legs just below the knees.
The study device has been tested in previous clinical studies. Previous studies suggest that each use of the study device may result in rapid reduction of RLS symptoms, such as reducing discomfort in the legs and feet and reducing the urge to move the legs and feet.
You will receive a fixed amount of compensation for your time and travel.
Yes, you can leave the study at any time.
The study will last approximately 8 weeks.
If you’re currently taking medication, you will be able to continue taking it during the study.
No, you will need to return the study devices after the study.