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Study of oral lidocaine (ORE-001) to reduce abdominal discomfort and early satiety in patients with anorexia nervosa

Fast replyInvestigationalNo placebo

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What is this trial about?

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

This study focuses on patients with Anorexia Nervosa, a serious eating disorder. The research examines a medication called ORE-001, which contains lidocaine hydrochloride, taken as a film-coated tablet. The medication is being tested to see if it can help reduce feelings of stomach discomfort and early fullness that people with anorexia nervosa often experience when eating.

The study compares ORE-001 to placebo to determine if the medication can help patients feel less full after meals and improve their ability to eat. The medication is taken by mouth and can be adjusted to different doses based on individual needs, up to 400 mg per day. The total treatment period lasts for 28 days.

During the study, researchers will monitor various aspects of patients' health, including changes in feelings of fullness, digestive symptoms, body weight, food intake, sleep patterns, and overall well-being. The study will also measure certain substances in the body that are related to feelings of hunger and fullness. This is done to better understand how the medication works and ensure it is safe for patients.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment and trial start
The clinical trial begins with an initial assessment to confirm your eligibility as a female patient aged 18-45 with anorexia nervosa
Your Body Mass Index (BMI) will be measured to confirm it is above 13
Initial measurements will be taken to establish baseline values for your satiety sensations and body weight
Step 2
Treatment assignment
You will be randomly assigned to receive either ORE-001 (oral lidocaine) or a placebo tablet
Neither you nor your healthcare provider will know which treatment you are receiving
The medication comes in the form of film-coated tablets
Step 3
28-day treatment period
You will take the assigned medication daily for 28 days
Regular measurements will be taken to track your progress:
Your feelings of fullness will be measured using a Visual Analog Scale (VAS)
Your body weight will be monitored
The amount of food and calories you consume at each meal will be recorded
Your sleep patterns will be evaluated
Blood samples will be taken to measure markers related to appetite and satiety
Step 4
Final assessment
At day 28, final measurements will be taken to compare with your initial baseline values
Your overall well-being and any side effects will be evaluated
The study team will monitor for any adverse effects throughout the entire study period

Who can join the trial?

7 criteria

You must be able to understand the study requirements and provide written consent before starting
You must be a female between 18 and 45 years old
You must be currently hospitalized and receiving psychological treatment for anorexia nervosa for at least 3 months
You must be willing and able to follow all study procedures and complete the entire study
Your BMI (Body Mass Index - a measure of body weight in relation to height) must be above 13, which indicates moderate-to-severe anorexia nervosa according to DSM-5 (the main manual used by mental health professionals to diagnose mental conditions)
You must be diagnosed with either the restricting type or binge-eating/purging type of anorexia nervosa according to DSM-5 criteria
You must have a confirmed diagnosis of anorexia nervosa that meets all the DSM-5 diagnostic criteria

Who cannot join the trial?

13 criteria

Not meeting the age requirement of 18-64 years old
Being male (study is only open to female participants)
Current pregnancy or breastfeeding
Having a Body Mass Index (BMI) above 17.5 (BMI is a measure of body fat based on height and weight)
Having serious medical conditions affecting the heart, liver, or kidneys
Current substance abuse or dependence
Having severe psychiatric conditions other than anorexia nervosa
Taking medications that could interfere with the study drug
Participation in another clinical trial within the past 30 days
History of allergic reactions to similar medications
Inability to follow study procedures or attend scheduled visits
Having uncontrolled medical conditions that could affect study results
Current use of medications for weight gain or appetite stimulation

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Responsive
IRCCS Ospedale Auxologico San Luca
Milan, Italy

Trial locations

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Investigated drugs

Oral Lidocaine (ORE-001) is a medication typically used as a local anesthetic. In this trial, it is being studied as an oral treatment for patients with anorexia nervosa. The medication aims to reduce stomach discomfort and feelings of fullness after eating, which may help patients with anorexia nervosa to eat more comfortably. It works by temporarily numbing certain nerve endings that signal fullness and discomfort in the digestive system.

Lidocaine Hydrochloride Monohydrate

What is already known about the treatment

Lidocaine (ORE-001) – An oral medication being investigated for treating symptoms associated with anorexia nervosa, particularly focusing on reducing early satiety and abdominal discomfort. This local anesthetic agent, traditionally used in injectable form for pain management, is being studied in an oral formulation to help patients with eating disorders manage postprandial fullness. The medication works by blocking sodium channels in nerve cells, which temporarily prevents nerve signals from transmitting sensations of fullness and discomfort, and belongs to the amino amide-type local anesthetic class of drugs. Currently undergoing clinical trials, this novel oral application of lidocaine represents an innovative approach to addressing the physical symptoms that can impede food intake in anorexia nervosa patients.

Investigated diseases

Anorexia Nervosa – A serious eating disorder characterized by an intense fear of gaining weight and a distorted body image. People with this condition maintain an abnormally low body weight by severely restricting their food intake, exercising excessively, or both. The disorder typically begins during adolescence or early adulthood and affects mostly females, though males can also develop it. It involves persistent behavior that interferes with maintaining a healthy body weight, along with difficulties in recognizing the seriousness of the low body weight. Physical effects include muscle loss, weakness, and problems with normal bodily functions.