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Migraine drug shows promise for IBS belly pain in small study

NCT ID NCT06221111

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study tested whether rimegepant (Nurtec), a drug used for migraines, can reduce chronic abdominal pain in people with irritable bowel syndrome (IBS). Thirty-nine adults with non-constipation IBS took either the drug or a placebo for 28 days. Researchers measured changes in daily pain scores using a 100-point scale, along with bowel movement frequency and rectal function.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
rimegepant (Nurtec)
What this could lead to
If it works, this could point toward a new option for easing chronic abdominal pain in people with irritable bowel syndrome.
What could go wrong
This is a small, early pilot study with only 39 participants. The results may not apply to everyone, and the drug might not prove effective in larger trials.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

39 people

The number who actually took part.

Started

Jun 2024

Finished

Jun 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905, United States

More trials for these conditions

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