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Study on the Effects and Safety of Piromelatine for Patients with Idiopathic Rapid Eye Movement Behavior Disorder (iRBD)

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a sleep disorder known as idiopathic Rapid Eye Movement Behavior Disorder (iRBD). This condition is characterized by unusual movements and vocal sounds during the rapid eye movement (REM) stage of sleep. The study will explore the effects of a medication called Piromelatine (Neu-P11), which is taken in tablet form. Piromelatine is a chemical compound that acts on certain receptors in the brain related to sleep regulation.

The purpose of the study is to assess the effectiveness and safety of Piromelatine over a short-term period of six weeks. Participants will take the medication and their sleep patterns will be monitored in a sleep laboratory setting. This involves observing changes in sleep behavior and any improvements in the symptoms of iRBD. The study will also monitor the participants' overall health and any side effects that may occur during the treatment period.

Throughout the study, participants will undergo various assessments to evaluate the severity of their sleep disorder and the impact of the treatment. These assessments will include monitoring sleep stages, muscle activity, and other sleep-related variables. The study aims to provide valuable insights into how Piromelatine can help manage iRBD and improve the quality of sleep for those affected by this disorder.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant will provide written informed consent, indicating understanding and agreement to comply with all trial procedures and restrictions.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm the diagnosis of idiopathic Rapid Eye Movement Behavior Disorder (iRBD) using polysomnography (PSG) and to ensure no other sleep disorders are present.

    The participant's physical examination, vital signs, laboratory test results, and electrocardiogram (ECG) will be evaluated to ensure they meet the study's inclusion criteria.

  3. Step 3

    Medication administration

    The participant will begin taking piromelatine in tablet form, administered orally.

    The treatment will last for a period of 6 weeks, with the dosage and frequency determined by the study protocol.

  4. Step 4

    Monitoring and evaluation

    Throughout the 6-week treatment period, the participant's iRBD severity will be assessed using video polysomnography (vPSG) and other measures such as electromyography and sleep hypnographic variables.

    Safety parameters, including vital signs, physical examination, adverse events, and laboratory assessments, will be monitored regularly.

  5. Step 5

    Final assessment

    At the end of the 6-week treatment period, a final assessment will be conducted to evaluate the efficacy and safety of the treatment compared to baseline measures.

    The participant's response to the treatment will be analyzed, and any changes in iRBD severity and sleep patterns will be documented.

Who can join the trial?

7 criteria

  • The participant must understand the study procedures and agree to participate by providing written informed consent.
  • The participant must be willing and able to comply with all trial procedures and restrictions.
  • Male or female adult participants aged 50 to 70 years diagnosed with iRBD (idiopathic Rapid Eye Movement Behavior Disorder) based on specific criteria and confirmed by a sleep study called vPSG (video Polysomnography).
  • The sleep study (PSG) must show that the participant does not have other sleep disorders or significant low oxygen levels during sleep (oxygen saturation 90% or less for 5% or more of total sleep time) and that their apnea-hypopnea index (AHI) is 15 or less. AHI is a measure of sleep apnea severity.
  • Any allowed medications must be at a stable dose for 3 months.
  • The participant's body mass index (BMI) must be between 18 and 32 kg/m². BMI is a measure of body fat based on height and weight.
  • The participant must have normal results from a physical exam, vital signs, lab tests, and heart test (ECG), or any abnormal results must be considered not significant by the study doctor.

Who cannot join the trial?

6 criteria

  • Patients with any other sleep disorders besides **idiopathic (isolated) Rapid Eye Movement Behavior Disorder**. This means if you have other sleep issues, you cannot participate.
  • Patients who are currently taking medications that might interfere with the study drug, **piromelatine**. This means if you are on certain medications, you may not be eligible.
  • Patients with serious medical conditions that could affect the study results. This means if you have a major health issue, you might not be able to join.
  • Patients who are pregnant or breastfeeding. This means if you are expecting a baby or nursing, you cannot participate.
  • Patients who have participated in another clinical trial recently. This means if you were part of another study not long ago, you may not be eligible.
  • Patients with a history of drug or alcohol abuse. This means if you have had problems with substance use, you might not be able to join.
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Investigated drugs

Piromelatine is being studied for its effectiveness and safety in treating patients with idiopathic Rapid Eye Movement Behavior Disorder (iRBD). This medication is being tested over a short-term period of 6 weeks to see how well it works in improving sleep-related symptoms associated with this disorder. The trial aims to compare the effects of piromelatine to the patients' condition before starting the treatment.

What is already known about the treatment

Piromelatine – Piromelatine is administered orally in the form of tablets. It is currently being studied in clinical trials for its potential use in treating idiopathic Rapid Eye Movement Behavior Disorder (iRBD). The main therapeutic indication for piromelatine is to improve sleep quality and reduce abnormal movements during sleep in patients with iRBD. At the molecular level, piromelatine acts by modulating melatonin and serotonin receptors, which are involved in regulating sleep-wake cycles and mood. It is classified pharmacologically as a melatonin receptor agonist and serotonin receptor modulator.

Investigated diseases

Idiopathic Rapid Eye Movement Sleep Behavior Disorder – This disorder is characterized by the acting out of dreams during the REM stage of sleep, often involving vocalizations and sudden, sometimes violent, movements. It occurs when the normal paralysis that accompanies REM sleep is absent, allowing individuals to physically act out their dreams. The condition is termed "idiopathic" when it occurs without an identifiable cause or association with other neurological disorders. Over time, the frequency and intensity of these episodes can vary, and they may disrupt sleep for both the affected individual and their bed partner. The disorder is more common in older adults and is often associated with other neurodegenerative conditions. Monitoring and assessment typically involve sleep studies to evaluate the severity and characteristics of the disorder.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-506713-22-00Protocol codePiromelatine PSG-RBDEstimated enrolment12 patientsSponsorNeurim Pharmaceuticals (1991) Ltd.

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