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Ecopipam Hydrochloride

Ecopipam Hydrochloride is an investigational drug being studied in clinical trials for its potential in treating Tourette’s Disorder and its effects on cardiac repolarization. These trials aim to assess the efficacy, safety, and tolerability of Ecopipam in various patient populations, including children, adolescents, and adults. The studies also evaluate the drug’s impact on heart function, providing crucial information for its development as a potential treatment option.

Table of Contents

What is Ecopipam Hydrochloride?

Ecopipam Hydrochloride, also known as EBS-101, is a new medication being studied for the treatment of Tourette’s Disorder[1]. Tourette’s Disorder is a neurological condition characterized by repetitive, involuntary movements and vocalizations called tics. These tics can range from mild to severe and can significantly impact a person’s quality of life.

How Does Ecopipam Work?

Ecopipam is classified as a selective dopamine D1 and D5 receptor antagonist[1]. This means it works by blocking specific receptors in the brain that are involved in the transmission of dopamine, a neurotransmitter associated with movement control and reward. By targeting these specific receptors, Ecopipam may help reduce the frequency and severity of tics in people with Tourette’s Disorder.

Treating Tourette’s Disorder

Ecopipam is being investigated as a potential treatment for Tourette’s Disorder in children, adolescents, and adults[1]. The medication is administered as oral tablets, which are taken daily in the evening. The dosage is typically calculated based on the patient’s body weight, with a target dose of 1.8 mg/kg/day of Ecopipam (equivalent to 2 mg/kg/day of Ecopipam Hydrochloride)[1].

Current Clinical Trials

A Phase 3 clinical trial is currently underway to evaluate the effectiveness and safety of Ecopipam in treating Tourette’s Disorder[1]. This study includes:

  • Open-label period: All participants receive Ecopipam for 12 weeks to determine if they respond to the treatment.
  • Randomized withdrawal period: Participants who respond well to Ecopipam are randomly assigned to either continue the medication or switch to a placebo for 12 weeks.

The main goal of this study is to assess whether Ecopipam can maintain its effectiveness over time and to further evaluate its safety profile[1].

Safety Studies

In addition to evaluating Ecopipam’s effectiveness in treating Tourette’s Disorder, researchers are conducting thorough safety studies. One such study is specifically designed to assess the medication’s effects on heart rhythm[2]. This type of study, known as a “Thorough QT/QTc Study,” is important because some medications can affect the heart’s electrical activity, potentially leading to serious side effects.

The heart rhythm study involves:

  • Testing both therapeutic (200 mg) and supratherapeutic (600 mg) doses of Ecopipam
  • Comparing Ecopipam’s effects to those of a placebo and a known heart rhythm-affecting drug (moxifloxacin)
  • Monitoring participants’ heart activity through ECGs (electrocardiograms) for up to 48 hours after taking the medication
  • Analyzing blood samples to understand how the body processes Ecopipam

This comprehensive safety evaluation will help researchers better understand Ecopipam’s potential risks and ensure its safe use in patients with Tourette’s Disorder[2].

Potential Side Effects

As with any medication, Ecopipam may cause side effects. The ongoing clinical trials are designed to identify and assess these potential side effects[1,2]. Some areas being closely monitored include:

  • Changes in heart rate and rhythm
  • Effects on blood pressure
  • Impacts on other vital signs
  • Any unexpected adverse events

It’s important to note that the full range of potential side effects is still being studied, and more information will become available as the clinical trials progress[1,2].

Aspect Details
Drug Name Ecopipam Hydrochloride
Primary Condition Studied Tourette’s Disorder
Secondary Study Focus Effects on cardiac repolarization (QT/QTc interval)
Study Populations Children, adolescents, and adults with Tourette’s Disorder; Healthy adult subjects
Main Efficacy Measure Yale Global Tic Severity Scale (YGTSS)
Study Designs Double-blind, placebo-controlled, randomized withdrawal; Thorough QT/QTc study
Dosages Studied 1.8 mg/kg/day (therapeutic); 200 mg and 600 mg (for cardiac safety study)
Key Safety Assessments Cardiac effects, adverse events, pharmacokinetics

FAQ

  • What is Ecopipam Hydrochloride? Ecopipam Hydrochloride is an investigational drug that acts as a selective dopamine D1 and D5 receptor antagonist. It is being studied for its potential in treating Tourette's Disorder and its effects on heart function.
  • What is the main purpose of the clinical trials involving Ecopipam Hydrochloride? The main purposes are to evaluate the efficacy, safety, and tolerability of Ecopipam in treating Tourette's Disorder, and to assess its effects on cardiac repolarization (heart function) in healthy individuals.
  • Who can participate in these clinical trials? The trials involve different groups. One study includes children, adolescents, and adults with Tourette's Disorder. Another study involves healthy adult subjects to assess the drug's effects on heart function.
  • How is the effectiveness of Ecopipam measured in Tourette's Disorder? The effectiveness is primarily measured using the Yale Global Tic Severity Scale (YGTSS), a clinician-completed rating scale that ranges from 0 (none) to 50 (severe).
  • What are the potential side effects being monitored in these trials? The trials are monitoring for various side effects, including any changes in heart rhythm (QT interval), heart rate, and other cardiac parameters. They are also tracking any treatment-emergent adverse events that may occur during the study periods.

Ongoing Clinical Trials on Ecopipam Hydrochloride

  • Study on the Effects of Ecopipam Hydrochloride for Children and Adolescents with Tourette’s Disorder

    Not recruiting

    3 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Denmark France Germany Hungary Italy +3

  • Study on the Long-Term Safety of Ecopipam Hydrochloride Tablets for Children, Adolescents, and Adults with Tourette’s Disorder

    Not recruiting

    3 1 1
    Investigated drugs:
    Bulgaria Denmark France Germany Hungary Italy +2

Glossary

  • Ecopipam Hydrochloride: An investigational drug that selectively blocks dopamine D1 and D5 receptors in the brain, being studied for its potential to treat Tourette's Disorder and its effects on heart function.
  • Tourette's Disorder: A neurological condition characterized by repetitive, involuntary movements and vocalizations called tics.
  • Yale Global Tic Severity Scale (YGTSS): A clinical rating scale used to measure the severity of tics in Tourette's Disorder, with scores ranging from 0 (no tics) to 50 (severe tics).
  • QT/QTc interval: A measure of the heart's electrical activity, specifically the time between the start of the Q wave and the end of the T wave in an electrocardiogram (ECG). It's important for assessing the risk of certain heart rhythm problems.
  • Cardiac repolarization: The process by which the heart muscle cells return to their resting state after contraction, important for maintaining normal heart rhythm.
  • Placebo: An inactive substance that looks like the drug being tested but has no medical effect, used as a control in clinical trials.
  • Double-blind study: A type of clinical trial where neither the participants nor the researchers know who is receiving the actual treatment and who is receiving a placebo.
  • Randomized withdrawal: A study design where participants who respond to the treatment are randomly assigned to continue the treatment or switch to a placebo, used to evaluate the long-term efficacy of a drug.
  • Pharmacokinetics: The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.
  • Adverse event: Any unfavorable and unintended sign, symptom, or disease that occurs during a clinical trial, whether or not it is related to the treatment being studied.

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