Phase 2 N=24 Randomized Quadruple-blind Treatment

Comparison of Rimegepant and Placebo for Pain in IBS

Irritable Bowel Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT06221111 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2026

Primary outcome: Primary: Change in Abdominal Pain Scores — -12; -22.6 score on a scale — p=0.41

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Rimegepant 75 MG [Nurtec] (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Mayo Clinic
Primary completion: May 2025

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Abdominal Pain Scores	-12; -22.6	0.41
SECONDARY Change in Bowel Movement Frequency	-0.2; -0.9	0.043 sig
SECONDARY Change in Rectal Compliance	2.1; -0.1	0.041 sig
SECONDARY Change in Rectal Sensation Pain Threshold	4.0; 0.0	0.098
SECONDARY Change in Rectal Sensation Ratings in Response to 24 and 36 mmHg Distensions	-23.5; -7; -13.5; -6; -11; 4	0.021 sig
SECONDARY Gastric Emptying of Solids	0.9; 0.9	0.22
SECONDARY Change in Colonic Transit at 24 Hours	-0.3; 0.4	0.90
SECONDARY Colonic Transit at 48 Hours	4.7; 4.3	0.86
SECONDARY Irritable Bowel Syndrome Quality of Life	61.4; 74.3; 75; 73.2; 72.8; 75	0.21
SECONDARY Number of Participants Who Experienced an Adverse Event	3; 3	—

Summary

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

Eligibility Criteria

Twenty-four participants with non-constipation IBS and chronic abdominal pain will be recruited for enrollment. Participants will meet specific Rome III IBS diagnostic criteria.

Inclusion criteria

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.

Exclusion criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06221111). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.