A Phase 2 interventional study of Rimegepant 75 MG [Nurtec] in Irritable Bowel Syndrome, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-05-22.
Sponsored by Mayo Clinic · Phase 2, Interventional, and Treatment
The primary aim of this study is to evaluate the efficacy of rimegepant on abdominal pain scores in participants with non-constipation IBS.
Irritable bowel syndrome (IBS) and, particularly, the pain component of IBS lack effective treatments. Antispasmodics, antidepressants and hypnotherapy have all been proposed for the treatment of pain. Their effectiveness in clinical practice is disappointing, despite meta-analyses suggesting efficacy. The study hypotheses are: that rimegepant will be safe, well-tolerated, and will improve abdominal pain in participants with non-constipation IBS. The primary aim is to evaluate the efficacy of rimegepant on abdominal pain scores in participants with non-constipation IBS. Secondary aims of this study are:
The trial period will consist of a two week run-in period, and 4 week treatment period. Participants will complete a daily diary regarding abdominal pain and stool consistency. They will also complete questionnaires studies of anxiety and depression and IBS-QOL.
An established and validated method using rectal barostat device will be used to measure rectal compliance and sensation. The standard scintigraphic method to measure colonic transit established in the Clinical Research Trials Unit (CRTU) at Mayo Clinic Rochester will be used to evaluate changes in colonic transit.
Anticipated results and Significance: Rimegepant, at doses and mode of administration approved by FDA for the prophylaxis of migraine headache, will be efficacious in the reduction of abdominal pain and rectal sensation in participants with non-constipation IBS and abdominal pain.
This study will provide an early signal of efficacy that may lead to future randomized, controlled trials.
1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.
This study's enrollment of 39 is below the median of 71 across 853 interventional studies indexed under Irritable Bowel Syndrome.
Browse Irritable Bowel Syndrome studies →Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
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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:
Exclusion criteria:
* 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 ODT appearing identical to the experimental formulation and administered every other day for 4 weeks/30 days
Drug: Rimegepant 75 MG [Nurtec]
placebo controlled trial
Also known as: placebo
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.
Time frame: Baseline; Day 28
Change in Bowel Movement Frequency
The change in bowel movement frequency measured by the number of bowel movements a participant reported having each day from baseline through day 28.
Time frame: Baseline; Day 28
Change in Rectal Compliance
The change in rectal compliance threshold defined as the change in pressure at half maximum volume (Pr 1/2) measured using a rectal barostat device. The rectal barostat device is a rectal catheter with a polyethylene bag attached (length 22 cm; capacity 600 ml) that is inserted into the rectum and connected to a barostat. The bag is unfolded by inflation with 75 ml of air, followed by complete deflation. After a 10 minute recovery period, the pressure is increased from 0 mmHg in steps of 4 mmHg for 15 seconds per step until 20 mmHg is reached. The observed volume/maximum observed volume will be used to obtain a pressure corresponding to half the maximum observed volume. A calculation of the pressures corresponding to the volumes just above and just below the half maximum volume will provided the specific pressure (Pr 1/2) corresponding to one half of the maximum observed volume.
Time frame: Baseline; Day 28
Change in Rectal Sensation Pain Threshold
The change in rectal sensation pain threshold in response to the pressure in the balloon escalating from 0 mmHg to 44 mmHg at 4 mmHg stepwise increases measured using the 100-mm Visual analog scale (VAS). The scale ranges from (unnoticeable) to (unbearable). The VAS line will be 100 mm long with no intermediate delineations. Each end will be marked with "unnoticeable" on the left, and "unbearable" on the right. Participants will identify their level of pain by indicating a point on the line between each end. That point will be measured from the "unnoticeable" 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.
Time frame: Baseline; Day 28
Change in Rectal Sensation Ratings in Response to 24 and 36 mmHg Distensions
The change in rectal sensation ratings in response to 24 mmHg and 36 mmHg distensions measured using the 100-mm Visual analog scale (VAS). The scale ranges from (unnoticeable) to (unbearable). The VAS line will be 100 mm long with no intermediate delineations. Each end will be marked with "unnoticeable" on the left, and "unbearable" on the right. Participants will identify their sensation of pain, urgency and gas levels by indicating a point on the line between each end. That point will be measured from the "unnoticeable" end, and the number of millimeters will be reported as the pain, gas and urgency scores. Total scores range from 0 to 100 with higher scores indicating worsening sensation of pain, urgency and gas.
Time frame: Baseline; Day 28
Gastric Emptying of Solids
Percentage of solids moved from the stomach to the small intestine (gastric emptying) at 4 hours on Day 28.
Time frame: Day 28
Change in Colonic Transit at 24 Hours
The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken at 4, 6, 8, 24, and 48 hours. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.
Time frame: Baseline; Day 28
Colonic Transit at 48 Hours
The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken at 4, 6, 8, 24, and 48 hours. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.
Time frame: Day 28
Irritable Bowel Syndrome Quality of Life
Irritable Bowel Syndrome Quality of Life (IBS-QOL) is a self-reported measure used to assess the impact of irritable bowel syndrome (IBS) on a participant's quality of life. The IBS-QOL consists of 34 items that cover eight distinct sub-domains, including emotional well-being, social functioning, dietary habits and intimate relationships. Each item is rated on a 5-point Likert scale, ranging from 1 (not at all) to 5 (a great deal). The raw scores are converted to a 0-100 scale where higher scores indicate a better quality of life.
Time frame: Baseline; Day 28; Day 56
Number of Participants Who Experienced an Adverse Event
The number of participants who experienced an Adverse Event.
Time frame: Day 1; Day 28
| Milestone | Rimegepant | Placebo |
|---|---|---|
| Started | 12 | 12 |
| Completed | 12 | 12 |
| Not completed | 0 | 0 |
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.
| score on a scale | Rimegepant | Placebo |
|---|---|---|
| Change in Abdominal Pain Scores | -12 (-16.9 to -6.4) | -22.6 (-30.3 to -8.1) |
The change in bowel movement frequency measured by the number of bowel movements a participant reported having each day from baseline through day 28.
| bowel movements per day | Rimegepant | Placebo |
|---|---|---|
| Change in Bowel Movement Frequency | -0.2 (-0.8 to 0) | -0.9 (-1 to -0.4) |
The change in rectal compliance threshold defined as the change in pressure at half maximum volume (Pr 1/2) measured using a rectal barostat device. The rectal barostat device is a rectal catheter with a polyethylene bag attached (length 22 cm; capacity 600 ml) that is inserted into the rectum and connected to a barostat. The bag is unfolded by inflation with 75 ml of air, followed by complete deflation. After a 10 minute recovery period, the pressure is increased from 0 mmHg in steps of 4 mmHg for 15 seconds per step until 20 mmHg is reached. The observed volume/maximum observed volume will be used to obtain a pressure corresponding to half the maximum observed volume. A calculation of the pressures corresponding to the volumes just above and just below the half maximum volume will provided the specific pressure (Pr 1/2) corresponding to one half of the maximum observed volume.
| mmHg | Rimegepant | Placebo |
|---|---|---|
| Change in Rectal Compliance | 2.1 (-1.3 to 7) | -0.1 (-4.2 to 2.2) |
The change in rectal sensation pain threshold in response to the pressure in the balloon escalating from 0 mmHg to 44 mmHg at 4 mmHg stepwise increases measured using the 100-mm Visual analog scale (VAS). The scale ranges from (unnoticeable) to (unbearable). The VAS line will be 100 mm long with no intermediate delineations. Each end will be marked with "unnoticeable" on the left, and "unbearable" on the right. Participants will identify their level of pain by indicating a point on the line between each end. That point will be measured from the "unnoticeable" 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.
| score on a scale | Rimegepant | Placebo |
|---|---|---|
| Change in Rectal Sensation Pain Threshold | 4.0 (-4.0 to 10.0) | 0.0 (-4.0 to 4.0) |
The change in rectal sensation ratings in response to 24 mmHg and 36 mmHg distensions measured using the 100-mm Visual analog scale (VAS). The scale ranges from (unnoticeable) to (unbearable). The VAS line will be 100 mm long with no intermediate delineations. Each end will be marked with "unnoticeable" on the left, and "unbearable" on the right. Participants will identify their sensation of pain, urgency and gas levels by indicating a point on the line between each end. That point will be measured from the "unnoticeable" end, and the number of millimeters will be reported as the pain, gas and urgency scores. Total scores range from 0 to 100 with higher scores indicating worsening sensation of pain, urgency and gas.
| score on a scale | Rimegepant | Placebo |
|---|---|---|
| Gas at 24 mmHg | -23.5 (-35 to -0.5) | -7 (-21 to 14) |
| Urgency at 24 mmHg | -13.5 (-32 to -7) | -6 (-14 to -0.5) |
| Pain at 24 mmHg | -11 (-29 to 1) | 4 (-2 to 10) |
| Gas at 36 mmHg | -1 (-26 to 6) | -1 (-6 to 13) |
| Urgency at 36 mmHg | -12 (-27 to 2) | 0.5 (-5 to 8) |
| Pain at 36 mmHg | -12 (-20 to 9) | 3 (-1 to 8) |
Percentage of solids moved from the stomach to the small intestine (gastric emptying) at 4 hours on Day 28.
| percentage of solids emptied | Rimegepant | Placebo |
|---|---|---|
| Gastric Emptying of Solids | 0.9 (0.8 to 1) | 0.9 (0.7 to 1) |
The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken at 4, 6, 8, 24, and 48 hours. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.
| units on a scale | Rimegepant | Placebo |
|---|---|---|
| Change in Colonic Transit at 24 Hours | -0.3 (-1.2 to 1.6) | 0.4 (-0.3 to 1.1) |
The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken at 4, 6, 8, 24, and 48 hours. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.
| units on a scale | Rimegepant | Placebo |
|---|---|---|
| Colonic Transit at 48 Hours | 4.7 (2.7 to 5) | 4.3 (2.8 to 4.9) |
Irritable Bowel Syndrome Quality of Life (IBS-QOL) is a self-reported measure used to assess the impact of irritable bowel syndrome (IBS) on a participant's quality of life. The IBS-QOL consists of 34 items that cover eight distinct sub-domains, including emotional well-being, social functioning, dietary habits and intimate relationships. Each item is rated on a 5-point Likert scale, ranging from 1 (not at all) to 5 (a great deal). The raw scores are converted to a 0-100 scale where higher scores indicate a better quality of life.
| score on a scale | Rimegepant | Placebo |
|---|---|---|
| Baseline | 61.4 (46.3 to 70.6) | 74.3 (53.7 to 84.9) |
| Day 28 | 75 (57.7 to 83.1) | 73.2 (64.3 to 89.3) |
| Day 56 | 72.8 (51.5 to 89.7) | 75 (50 to 80.9) |
The number of participants who experienced an Adverse Event.
| Participants | Rimegepant | Placebo |
|---|---|---|
| Number of Participants Who Experienced an Adverse Event | 3 | 3 |
Collected over Adverse events were collected from the date the participant received the first dose of medication through the washout period, approximately 56 days.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Rimegepant | 0/12 (0%) | 0/12 (0%) | 3/12 (25%) |
| Placebo | 0/12 (0%) | 0/12 (0%) | 3/12 (25%) |
| Event | Rimegepant | Placebo |
|---|---|---|
| Change of bowel habit (reduced frequency)Gastrointestinal disorders | 2/12 | 0/12 |
| RetchingGastrointestinal disorders | 0/12 | 1/12 |
| MigraineNervous system disorders | 0/12 | 1/12 |
| NauseaGastrointestinal disorders | 1/12 | 0/12 |
| VomitingGastrointestinal disorders | 1/12 | 1/12 |
| RashInfections and infestations | 1/12 | 0/12 |
| Postural Orthostatic Tachycardia SyndromeNervous system disorders | 0/12 | 1/12 |
| Age, Continuous(years) | Rimegepant | Placebo | Total |
|---|---|---|---|
| Median | 38 (29 to 43) | 38 (28.5 to 43) | 38.0 (29.0 to 43.0) |
| Sex: Female, Male(Participants) | Rimegepant | Placebo | Total |
|---|---|---|---|
| Female | 10 | 7 | 17 |
| Male | 2 | 5 | 7 |
| Ethnicity (NIH/OMB)(Participants) | Rimegepant | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 12 | 12 | 24 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Rimegepant | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 12 | 12 | 24 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Rimegepant | Placebo | Total |
|---|---|---|---|
| United States | 12 | 12 | 24 |
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