Ethosuximide to Treat IBS

NCT02973542 | Completed Phase 2

• 2 other identifiers: CHU-2892016-002110-42
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Irritable Bowel Syndrome

Keywords

IBS; Ethosuximide; Pain

Outcome Measures

Primary Outcomes (2)

• 30% reduction in abdominal pain

  through study completion, an average of 12 weeks.

• Score of 4 or 5 on the SGA scale

  through study completion, an average of 12 weeks.

Secondary Outcomes (13)

• Monthly assessment of abdominal pain

  at 1 month

• Monthly assessment of score of Bristol scale

  at 1 month

• Monthly evaluation of GIQLI questionnaire

  at 1 month

• Monthly evaluation of EQ-5D questionnaire

  at 1 month

• Monthly evaluation of IBS-SSS questionnaire

  at 1 month

Study Arms (2)

ethosuximide

EXPERIMENTAL

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

placebo

PLACEBO COMPARATOR

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

Interventions

Ethosuximide DRUG

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.

ethosuximide

Placebo OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years,
• Man,
• Women, Negative pregnancy test and effective contraception,
• IBS defined by the Rome criteria IV
• IBS Treatment stable for 1 month
• Patients affiliated to the French Social Security,
• Patients with the informed consent were obtained.

You may not qualify if:

• 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 undergoing a measure of legal protection (trusteeship, guardianship ...).

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• SFETD (Socièté Française d'Etude et de Traitement de la Douleur): collaborator

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Related Publications (2)

• Kerckhove N, Zerbib F, Chambaz M, Mion F, Zalar A, Goutorbe F, Coffin B, Payen L, Roman S, Guilngar A, Pereira B, Duale C, Dapoigny M, Melchior C, Scanzi J; IBSET Investigator Group (IIG). Ethosuximide and Irritable Bowel Syndrome-Related Abdominal Pain: A Randomized Clinical Trial. JAMA Netw Open. 2026 Jan 2;9(1):e2551368. doi: 10.1001/jamanetworkopen.2025.51368.

  PMID: 41505133 RESULT

• Kerckhove N, Scanzi J, Pereira B, Ardid D, Dapoigny M. Assessment of the effectiveness and safety of ethosuximide in the treatment of abdominal pain related to irritable bowel syndrome - IBSET: protocol of a randomised, parallel, controlled, double-blind and multicentre trial. BMJ Open. 2017 Jul 18;7(7):e015380. doi: 10.1136/bmjopen-2016-015380.

  PMID: 28720615 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome; Pain

Interventions

Ethosuximide

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Succinimides; Imides; Organic Chemicals; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Julien SCANZI, MD

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2016
• First Posted: November 25, 2016
• Study Start: February 8, 2018
• Primary Completion: March 7, 2023
• Study Completion: May 7, 2023
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

FR (1)