Ensayos clínicos

Inclusion Criteria:

• Participants will be 18-65 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 by a Likert scale of at least >3.0 for enrollment; criterion required by FDA for recruitment of patients in therapeutic trials in IBS-pain.
• Participants will be capable of providing informed consent.

Exclusion Criteria:

• Diagnosis of moderate-severe depression as per BDI > 18.
• 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.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 11/2/23. Questions regarding updates should be directed to the study team contact.