Ongoing Clinical Trials for Restless Legs Syndrome
Currently, there are 3 clinical trials investigating new treatments for restless legs syndrome, a condition that causes uncomfortable leg sensations and an irresistible urge to move. These studies are testing different approaches, including medications that affect brain chemicals like dopamine and iron supplementation therapies. The trials are taking place in the Netherlands, Italy, and Austria, and are open to adults experiencing moderate to severe symptoms.
Clinical trial locations
- Austria
- Italy
- Netherlands
Study on Pramipexole for Treating Restless Legs in Women with X-linked Adrenoleukodystrophy
This trial is specifically designed for women living with X-linked adrenoleukodystrophy (X-ALD), a rare genetic condition that can cause various neurological symptoms including restless legs syndrome. The study will investigate how the medication Pramipexole Viatris may help improve symptoms related to leg movement, sleep quality, and walking ability.
Who can participate: The study is looking for women aged 18 or older who have been diagnosed with X-ALD. Participants need to be willing and able to follow study procedures and provide verbal consent. For the second phase of the study, women must have restless legs syndrome with a severity score greater than 15 on the International Restless Legs Scale. Women of childbearing age must use effective contraception during the study.
Who cannot participate: Men cannot join this study as it focuses specifically on women with X-ALD. Individuals who do not have X-ALD or restless legs syndrome are not eligible. The study also has specific age restrictions for certain phases.
What the study involves: Participants will take Pramipexole Viatris in tablet form by mouth. The study lasts up to 16 weeks and includes two phases. The first phase determines how common restless legs syndrome is among women with X-ALD. The second phase tests whether the medication can improve symptoms. During the study, researchers will monitor changes in sleep patterns, mood, quality of life, and the ability to perform daily activities. Some participants may receive a placebo for comparison purposes.
Investigational drug: The study tests Ropinirole (also marketed as Pramipexole Viatris), a medication that works by mimicking dopamine, a natural brain chemical that helps control movement. This medication aims to improve sleep and reduce uncomfortable leg sensations.
Study on the Effects of Dextromethadone Hydrochloride for Patients with Moderate to Very Severe Restless Legs Syndrome
This trial examines a medication called REL-1017, which contains the active ingredient dextromethadone hydrochloride. The study aims to determine how effective, safe, and tolerable this medication is for people experiencing moderate to very severe symptoms, including uncomfortable leg sensations and periodic limb movements during sleep.
Who can participate: Both men and women between 18 and 75 years old can join this study. Participants must have been diagnosed with primary restless legs syndrome and have moderate to very severe symptoms, determined by a score greater than 10 on the International Restless Legs Rating Scale.
Who cannot participate: People without a restless legs syndrome diagnosis are not eligible. Those with only mild symptoms (score of 10 or below) cannot participate. Individuals outside the age range of 18-75 years and members of vulnerable populations are excluded. Patients who are unwilling or unable to follow study procedures, including taking medication as directed and attending all required visits, cannot join.
What the study involves: Participants will receive either a daily 25 mg dose of REL-1017 or a placebo for 30 days. The medication is taken orally in tablet form. The study includes several assessments to monitor changes in symptoms and sleep patterns. These assessments occur at the beginning, after 10 days, and at the end of the 30-day treatment period, with follow-up assessments on days 31 and 37. The goal is to see if the medication can significantly reduce symptom severity and improve sleep quality by at least 50% from baseline measurements.
Investigational drug: d-Methadone is being studied for its potential to help people with moderate to very severe restless legs syndrome. At the molecular level, this medication works by modulating NMDA receptors in the brain, which are involved in pain and neurological functions.
Study on the Effects of Ferric Derisomaltose and Dopaminergic Therapy for Patients with Restless Legs Syndrome
This study investigates the effects of iron supplementation using ferric derisomaltose, either alone or in combination with dopaminergic therapy. Dopaminergic medications affect dopamine, a brain chemical that helps control movement. The trial explores whether iron treatment can help manage symptoms and improve quality of life.
Who can participate: Adults aged 18 or older who have been diagnosed with restless legs syndrome according to specific criteria can join. These criteria include an urge to move the legs with uncomfortable sensations that start or worsen during rest, are relieved by movement, and are worse in the evening or night. Participants must have a severity score of 15 or higher on the International Restless Legs Rating Scale. If already taking dopaminergic therapy, the dosage must not exceed the recommended maximum: Pramipexole 0.75 mg per day, Ropinirole 4 mg per day, or Rotigotine 3 mg per day. Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for at least one month after. Written, signed, and dated informed consent is required.
Who cannot participate: Patients outside the age range of 18-65 years cannot participate. Pregnant or breastfeeding women are not eligible. People with severe kidney disease, a history of iron overload disorders, recent heart attack or stroke, or uncontrolled high blood pressure are excluded. Patients currently participating in another clinical trial, those with known allergies to iron supplements, or those with a history of certain psychiatric disorders cannot join.
What the study involves: Participants will receive either iron supplementation (ferric derisomaltose) or a placebo through an intravenous infusion directly into a vein. Some participants may also receive dopaminergic therapy with medications such as Pramipexole, Ropinirole, or Rotigotine. Throughout the study, researchers will monitor changes in symptoms using the International Restless Legs Rating Scale. Additional monitoring includes blood tests to measure various health indicators, and some participants may undergo an MRI scan to assess iron content in specific brain areas. The study aims to understand how these treatments affect symptom management.
Investigational drugs: Iron Isomaltoside is an iron supplement designed to increase iron levels in the body, which is essential for producing red blood cells that carry oxygen. The study explores whether addressing potential iron deficiency can improve symptoms. Dopaminergic Therapy involves medications that affect dopamine levels in the brain, helping to control movement and emotional responses. The trial tests whether these treatments work better alone or in combination.
Summary
These three clinical trials represent different approaches to treating restless legs syndrome. One trial focuses specifically on women with a rare genetic condition (X-linked adrenoleukodystrophy), exploring whether symptoms related to this condition respond to dopamine-affecting medication. Another trial investigates a novel medication (dextromethadone hydrochloride) that works through a different mechanism involving NMDA receptors in the brain. The third trial explores whether iron supplementation, either alone or combined with standard dopaminergic therapies, can improve symptoms.
Geographically, these trials are distributed across three European countries—the Netherlands, Italy, and Austria—each testing distinct treatment approaches. All studies focus on moderate to severe symptoms and use standardized scales to measure symptom improvement. The trials emphasize safety monitoring and quality of life assessments alongside symptom reduction. Participants in these studies will contribute valuable information that may lead to better treatment options for people living with this challenging condition.
