Ongoing Clinical Trials for Rapid Eye Movement Sleep Behaviour Disorder
There is currently 1 ongoing clinical trial for Rapid Eye Movement Sleep Behaviour Disorder (also known as: REM Sleep Behaviour Disorder, iRBD). This trial is investigating a medication called Piromelatine for patients experiencing this sleep disorder, which causes people to physically act out their dreams during sleep.
Clinical trial locations
Study on the Effects and Safety of Piromelatine for Patients with Idiopathic Rapid Eye Movement Behavior Disorder (iRBD)
This clinical trial is investigating Piromelatine, a medication taken in tablet form, for treating idiopathic Rapid Eye Movement Behavior Disorder. This condition occurs when people physically act out their dreams during the REM stage of sleep, which can involve unusual movements and vocal sounds. Normally, the body is paralyzed during REM sleep, but people with this disorder lack this protective mechanism.
Main inclusion criteria:
- Adults between 50 and 70 years old with a confirmed diagnosis of idiopathic REM Sleep Behavior Disorder
- Diagnosis must be confirmed through a sleep study (video polysomnography) conducted in a sleep laboratory
- Body mass index (BMI) between 18 and 32 kg/m²
- No other significant sleep disorders present, with an apnea-hypopnea index of 15 or less
- Normal results from physical examination, vital signs, laboratory tests, and heart tests, or any abnormalities considered not clinically significant
- Any ongoing medications must be at a stable dose for at least 3 months
- Willingness to comply with all trial procedures and provide written informed consent
Main exclusion criteria:
- Presence of other sleep disorders besides idiopathic REM Sleep Behavior Disorder
- Currently taking medications that could interfere with Piromelatine
- Serious medical conditions that could affect study results
- Pregnancy or breastfeeding
- Recent participation in another clinical trial
- History of drug or alcohol abuse
Focus and goal of the trial:
The study aims to evaluate both the effectiveness and safety of Piromelatine over a 6-week treatment period. Participants will take Piromelatine tablets orally, and their sleep patterns will be carefully monitored in a sleep laboratory setting. The research team will observe changes in sleep behavior and assess any improvements in symptoms. Throughout the study, participants will undergo various assessments to evaluate the severity of their sleep disorder and the impact of the treatment, including monitoring sleep stages, muscle activity, and other sleep-related variables.
Investigational drug:
Piromelatine (also known as Neu-P11) is a compound that works by modulating melatonin and serotonin receptors in the brain, which are involved in regulating sleep-wake cycles and mood. It is classified as a melatonin receptor agonist and serotonin receptor modulator. The medication is designed to improve sleep quality and reduce the abnormal movements that occur during sleep in patients with this disorder.
The trial involves five main steps: joining the study and providing informed consent, undergoing initial assessment to confirm diagnosis and eligibility, receiving the medication for 6 weeks, continuous monitoring and evaluation of symptoms and safety, and a final assessment to evaluate treatment effectiveness compared to baseline measurements.
Summary
Currently, only one clinical trial is actively recruiting patients with Rapid Eye Movement Sleep Behaviour Disorder. This trial is being conducted in Austria and focuses on evaluating Piromelatine as a potential treatment option. The study specifically targets adults aged 50 to 70 years with the idiopathic form of this disorder, meaning cases without an identifiable underlying cause. The research emphasizes careful patient selection, excluding those with other sleep disorders or serious medical conditions that could interfere with results. The 6-week treatment period with comprehensive sleep laboratory monitoring reflects a methodical approach to understanding both the benefits and safety profile of this investigational medication.