Comparison of Rimegepant and Placebo for Pain in IBS

NCT06221111 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 23-006559
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this study is to evaluate the efficacy of rimegepant on abdominal pain scores in participants with non-constipation IBS.

Conditions

Irritable Bowel Syndrome

Keywords

pain, IBS, CGRP, rimegepant, antagonist

Outcome Measures

Primary Outcomes (1)

• Change in Abdominal Pain Scores

  The change in daily abdominal pain scores will be assessed using the 100-mm Visual Analogue Scale (VAS). The VAS line will be 100 mm long with no intermediate delineations. Each end will be marked with "no pain" on the left, and "worst possible pain" on the right. Participants will identify their pain level by indicating a point on the line between each end. That point will be measured from the "No pain" end, and the number of millimeters will be reported as the pain score. Total scores range from 0 to 100 with higher scores indicating worse pain.

  Baseline; Day 28

Secondary Outcomes (9)

• Change in Bowel Movement Frequency

  Baseline; Day 28

• Change in Rectal Compliance

  Baseline; Day 28

• Change in Rectal Sensation Pain Threshold

  Baseline; Day 28

• Change in Rectal Sensation Ratings in Response to 24 and 36 mmHg Distensions

  Baseline; Day 28

• Gastric Emptying of Solids

  Day 28

Study Arms (2)

rimegepant

EXPERIMENTAL

* Rimegepant 75mg oral dissolving tablet (ODT) * Formulation and Dosing as FDA-approved for Migraine Prevention: 75 mg Every Other Day (EOD) for 4 weeks/30 days

Drug: Rimegepant 75 MG [Nurtec]

placebo

PLACEBO COMPARATOR

Placebo ODT appearing identical to the experimental formulation and administered every other day for 4 weeks/30 days

Drug: Rimegepant 75 MG [Nurtec]

Interventions

Rimegepant 75 MG [Nurtec] DRUG

placebo controlled trial

Also known as: placebo

placebo; rimegepant

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants will be 18-70 years of age.
• Participants will have non-constipation IBS \[that is IBS-D (diarrhea), IBS-M (mixed), or IBS-U (unspecified)\] with chronic abdominal pain diagnosed in their medical records at Mayo Clinic with chronic pain documented for ≥ 3 months.
• Participants will have subjective pain ratings of ≥ 30 on the 100 mm VAS during at least 7 consecutive days of the 2 week run-in period for enrollment.
• Participants will be capable of providing informed consent.

You may not qualify if:

• Diagnosis of moderate-severe depression as per HADS ≥15;
• Alcohol or illicit substance dependence or abuse in the past 12 months;
• Dementia, unprovoked seizure history, seizure disorder;
• Pregnancy (all women of childbearing potential will be required to have a negative pregnancy test prior to initiation, and will be on a highly effective method of contraception, as detailed in the consent form);
• Significant change or increase in antidepressant or pain medications within the last four weeks; significant change in primary treatment interventions for pain in the past four weeks;
• Medically unstable
• Severe hepatic or renal impairment, such as baseline AST or ALT ≥ 2.5 X upper normal limit or end-stage renal disease with estimated glomerular filtration rate or creatinine clearance \<15mL/min. Although Rimegepant is rarely associated with abnormal circulating liver enzymes, we shall exclude patients with baseline AST or ALT greater than 2.5 times the upper limit of normal.
• Concomitant use of strong CYP3A4 inhibitors and strong or moderate CYP3A4 inducers.
• Participants who report nausea several times per week or daily on the baseline bowel disease questionnaire (question # 16) will be excluded from the study because of the low risk of nausea induced by the treatment which was estimated at approximately 3% for rimegepant compared to 1% for placebo.

Sponsors & Collaborators

• Mayo Clinic: lead
• Pfizer: collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Irritable Bowel Syndrome; Pain; Ichthyosis Bullosa of Siemens

Interventions

rimegepant sulfate

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; Ichthyosis; Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Genetic Diseases, Inborn; Infant, Newborn, Diseases; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Michael Camilleri, M.D., D.Sc.
• Organization: Mayo Clinic

camilleri.michael@mayo.edu

507-266-2305

Study Officials

• Michael Camilleri

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: concealed allocation; blinded provision of assigned medication through research pharmacy
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Pharmacology and Physiology

Model Details: randomized, double-blind placebo-controlled trial of rimegepant at doses and route of administration approved by the FDA for the prophylaxis of migraine headache.

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: January 24, 2024
• Study Start: June 6, 2024
• Primary Completion: May 30, 2025
• Study Completion: June 3, 2025
• Last Updated: May 22, 2026
• Results First Posted: May 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)