Treating Visceral Sensation and Chronic Abdominal Pain with Rimegepant

Overview

About this study

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

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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 1 of the 2 run-in weeks for enrollment.
* 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 equal to or 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 9/26/2024. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Michael Camilleri, M.D., D.Sc.

Open for enrollment

Contact information:

Deborah Eckert R.N.

(507) 538-5860

Eckert.Deborah@mayo.edu

More information

Publications

Publications are currently not available