Ethosuximide to Treat IBS (IBSET)

April 16, 2026 updated by: University Hospital, Clermont-Ferrand

Evaluation of the Efficacy and Tolerance of Ethosuximide in the Treatment of Abdominal Pain Associated With Irritable Bowel Syndrome

Abdominal pain remains the most deleterious symptom for patients with irritable bowel syndrome (IBS) and is causing a significant alteration of their quality of life. The visceral hypersensitivity seems to be one of the key mechanisms that could explain the abdominal pain in these patients. Current treatments, mainly symptomatic, are of limited effectiveness, especially in terms of relief of abdominal pain. The study will aim to evaluate the effectiveness of ethosuximide on abdominal pain in patients with IBS, its tolerance and its impact on patient quality of life, severity of symptoms related to IBS and the use of analgesics / antispasmodic / regulators transit.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The irritable bowel syndrome (IBS) is characterized by a combination of discomfort and / or abdominal pain and bowel habits in the absence of identifiable organic pathology. This condition is extremely common because it is the first cause of consultation in gastroenterology and would cover 10-15% of the French. This chronic condition, although functional, impact significantly on the quality of life of patients and causes considerable health spending, making it a major public health problem. Especially as the currently used treatments are of limited effectiveness.

Among the pathophysiological mechanisms involved in IBS, visceral hypersensitivity (VHS) seems to be a major factor causing pain in patients. VHS involves sensitization of colonic nerve fibers, resulting in an increase of neuronal excitability. In several animal models of chronic pain, this hyperexcitability was related to a change in the expression or activity of ion channels, including calcium channel Cav3.2.

Investigators especially shown the involvement of Cav3.2 channels in visceral pain in an animal model of VHS. Furthermore, overexpression of these channels at the peripheral level (dorsal root ganglion innervating the colon) has been demonstrated in this animal model and pharmacological blockade, including ethosuximide, prevented the development of the VHS. Note that Cav3.2 channels have been widely demonstrated as involved in nociceptive phenomena in various animal models of chronic pain and that by blocking their ethosuximide induce an analgesic effect in these models.

Finally, we have recently demonstrated the involvement of Cav3.2 channel in patients with IBS, in a clinical case-control study. The Cav3.2 channels were overexpressed in the colonic mucosa of patients with IBS compared to asymptomatic controls.

The Cav3.2 channels are therefore a potential pharmacological target and ethosuximide a promising therapy to effectively treat the abdominal pain associated with IBS.

Study Type

Interventional

Enrollment (Actual)

162

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • CHU Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18 years,

    • Man,
    • Women, Negative pregnancy test and effective contraception,
    • IBS defined by the Rome criteria IV
    • During the previous seven days the inclusion visit, average NRS pain ≥ 4,
    • IBS Treatment stable for 1 month
    • Patients affiliated to the French Social Security,
    • Patients with the informed consent were obtained.

Exclusion Criteria:

  • Breastfeeding
  • Diabetic patients
  • Known renal or hepatic impairment,
  • Significant liver function abnormalities (transaminases> 3N, cholestasis) and renal (MDRD <60 ml / min)
  • Addiction to alcohol and / or drugs,
  • AEDs taken (epilepsy or chronic pain)
  • chronic pain of greater intensity than that related to IBS,
  • Allergy succinimides (ethosuximide, methsuximide, phensuximide)
  • History or current severe depression (hospitalization, long-term antidepressant treatment)
  • Psychotic disorders,
  • Patients exclusion period, or total exceeded authorized allowances
  • Patients undergoing a measure of legal protection (trusteeship, guardianship ...).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ethosuximide
A responder will correspond to a decrease in abdominal pain score (11-points NRS pain) of at least 30% compared to the score before treatment and a score of 6 or 7 on the SGA scale. At endpoint (12-weeks treatment period), it will be compared the responder rate between the 2 treatment arms (ethosuximide vs placebo).
Drug: Ethosuximide
The study will aim to evaluate the effectiveness of ethosuximide on abdominal pain in patients with IBS, its tolerance and its impact on patient quality of life, severity of symptoms related to IBS and the use of analgesics / antispasmodic / regulators transit.
Placebo Comparator: placebo
A responder will correspond to a decrease in abdominal pain score (11-points NRS pain) of at least 30% compared to the score before treatment and a score of 6 or 7 on the SGA scale. At endpoint (12-weeks treatment period), it will be compared the responder rate between the 2 treatment arms (ethosuximide vs placebo).
Other: Placebo
The study will aim to evaluate the effectiveness of ethosuximide on abdominal pain in patients with IBS, its tolerance and its impact on patient quality of life, severity of symptoms related to IBS and the use of analgesics / antispasmodic / regulators transit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
30% reduction in abdominal pain
Time Frame: through study completion, an average of 12 weeks.
through study completion, an average of 12 weeks.
Score of 4 or 5 on the SGA scale
Time Frame: through study completion, an average of 12 weeks.
through study completion, an average of 12 weeks.

Secondary Outcome Measures

Outcome Measure
Time Frame
Monthly assessment of abdominal pain
Time Frame: at 1 month
at 1 month
Monthly assessment of score of Bristol scale
Time Frame: at 1 month
at 1 month
Monthly evaluation of GIQLI questionnaire
Time Frame: at 1 month
at 1 month
Monthly evaluation of EQ-5D questionnaire
Time Frame: at 1 month
at 1 month
Monthly evaluation of IBS-SSS questionnaire
Time Frame: at 1 month
at 1 month
Monthly evaluation of SGA scale.
Time Frame: at 1 month
at 1 month
Monthly evaluation of the use of analgesics
Time Frame: at 1 month
at 1 month
Monthly evaluation of the use of antispasmodic
Time Frame: at 1 month
at 1 month
Monthly evaluation of the use of regulators transit.
Time Frame: at 1 month
at 1 month
Monthly evaluation of medical response rate
Time Frame: at 1 month
at 1 month
Monthly evaluation of stop work related to IBS.
Time Frame: at 1 month
at 1 month
Evaluation of the tolerance of ethosuximide throughout the study.
Time Frame: at 1 month
at 1 month
Evaluation of the discontinuation rate study because of adverse events throughout the study
Time Frame: at 1 month
at 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Collaborators

SFETD (Socièté Française d'Etude et de Traitement de la Douleur)

Investigators

  • Principal Investigator: Julien SCANZI, MD, University Hospital, Clermont-Ferrand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 8, 2018

Primary Completion (Actual)

March 7, 2023

Study Completion (Actual)

May 7, 2023

Study Registration Dates

First Submitted

November 18, 2016

First Submitted That Met QC Criteria

November 23, 2016

First Posted (Estimated)

November 25, 2016

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU-289
  • 2016-002110-42 (Other Identifier: 2016-002110-42)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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