Trial · NCT05248997

Safety and Efficacy of BHV-3000 (Rimegepant) Orally Disintegrating Tablet for the Acute Treatment of Chronic Rhinosinusitis

NCT05248997, Phase 3, Completed, Pfizer; results first posted 2025-03-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy of BHV-3000 (Rimegepant) Orally Disintegrating Tablet for the Acute Treatment of Chronic Rhinosinusitis. Trials, record NCT05248997. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05248997

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety and Efficacy of BHV-3000 (Rimegepant) Orally Disintegrating Tablet for the Acute Treatment of Chronic Rhinosinusitis
NCT number: NCT05248997
Status: Completed
Phases: Phase 3
Enrollment: 261 participants, actual
Lead sponsor: Pfizer
Conditions: Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps
Interventions: rimegepant 75 mg ODT, Matching placebo
First posted: 2022-02-21
Last updated: 2025-03-26
Results first posted: 2025-03-26

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Facial Pain/Pressure/Fullness on NRS at 2 Hours Post-Dose	Baseline, 2 hours post-dose	Facial pain/pressure/fullness was assessed using an NRS score ranging in integers from 0 to 10, with 0 being "no facial pain/pressure/fullness" and 10 being "worst imaginable facial pain/pressure/fullness." Higher scores signified worse condition.
Secondary	Change From Baseline in Total Nasal Symptom Score (TNSS) at 2 Hours Post-Dose	Baseline, 2 hours post-dose	TNSS was calculated as the sum of 3 symptom scores: facial pain/pressure/fullness, score ranged from 0 (no facial pain/pressure/fullness) to 10 (worst imaginable facial pain/pressure/fullness); nasal obstruction (congestion), score ranged from 0 (no nasal obstruction (congestion) to 10 (worst imaginable nasal obstruction (congestion); and nasal discharge, score ranged from 0 (no nasal discharge) to 10 (worst nasal discharge). TNSS overall score ranged from 0 (no nasal symptom) to 30 (worst nasal symptom); higher scores signified worse condition.
Secondary	Change From Baseline in Nasal Obstruction (Congestion) at 2 Hours Post-Dose	Baseline, 2 hours post-dose	Nasal obstruction (congestion) severity was assessed using a NRS ranging in integers from 0 (no nasal obstruction \[congestion\]) to 10 (worst imaginable nasal obstruction \[congestion\]). Higher scores signified worse condition.
Secondary	Change From Baseline in Nasal Discharge at 2 Hours Post-Dose	Baseline, 2 hours post-dose	Nasal discharge severity was assessed using a NRS ranging in integers from 0 (no nasal discharge) to 10 (worst imaginable nasal discharge). Higher scores signified worse condition.
Secondary	Percentage of Participants With Headache Pain Relief at 2 Hours Post-Dose	2 hours post-dose	Headache pain relief was defined as a headache pain level of none or mild at 2 hours post-dose on a 4-point Likert scale (0 = None; 1 = Mild; 2 = Moderate; 3 = Severe).
Secondary	Percentage of Participants Who Used Rescue Medication Within 24 Hours Post-dose	Through 24 hours post-dose	Post 2 hours after dosing with study medication and after the 2-hour assessments were completed on the e-diary, participants were permitted to use the following rescue medications (non-study medications) such as: acetaminophen or aspirin, ibuprofen, naproxen (or any other type of nonsteroidal anti-inflammatory drug \[NSAID\]), oral antihistamines (non- sedating), oral decongestants, topical nasal decongestants, topical nasal anticholinergics.

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Facial Pain/Pressure/Fullness on NRS at 2 Hours Post-Dose	Baseline, 2 hours post-dose	Modified Intent to Treat (mITT) analysis set included randomized participants that received study therapy, had a facial pain/pressure/fullness which reached pain intensity of \>= 6 on the NRS (0-10) prior to administration of treatment and provided at least one post-baseline efficacy data point in the e-diary. All assessments after rescue medication administration were set to missing. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.	Scores on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Total Nasal Symptom Score (TNSS) at 2 Hours Post-Dose	Baseline, 2 hours post-dose	mITT analysis set included randomized participants that received study therapy, had a facial pain/pressure/fullness which reached pain intensity of \>= 6 on the NRS (0-10) prior to administration of treatment and provided at least one post-baseline efficacy data point in the e-diary. All assessments after rescue medication administration were set to missing. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.	Scores on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Nasal Obstruction (Congestion) at 2 Hours Post-Dose	Baseline, 2 hours post-dose	mITT analysis set included randomized participants that received study therapy, had a facial pain/pressure/fullness which reached pain intensity of \>=6 on the NRS (0-10) prior to administration of treatment and provide at least one post-baseline efficacy data point in the e-diary. All assessments after rescue medication administration were set to missing. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.	Scores on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Nasal Discharge at 2 Hours Post-Dose	Baseline, 2 hours post-dose	mITT analysis set included randomized participants that received study therapy, had a facial pain/pressure/fullness which reached pain intensity of \>= 6 on the NRS (0-10) prior to administration of treatment and provide at least one post-baseline efficacy data point in the e-diary. All assessments after rescue medication administration were set to missing. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.	Scores on a scale	LEAST_SQUARES_MEAN
SECONDARY	Percentage of Participants With Headache Pain Relief at 2 Hours Post-Dose	2 hours post-dose	mITT analysis set analyzed. Participants who reported a headache pain level of moderate or severe intensity at baseline were assessed. Participants who had missing data at 2 hours post-dose, or who took rescue medication at or before 2 hours post-dose were imputed as failures. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.	Percentage of Participants	NUMBER
SECONDARY	Percentage of Participants Who Used Rescue Medication Within 24 Hours Post-dose	Through 24 hours post-dose	mITT analysis set included randomized participants that received study therapy, had a facial pain/pressure/fullness which reached pain intensity of greater than or equal to (\>=) 6 on the NRS (0-10) prior to administration of treatment and provided at least one post-baseline efficacy data point in the e-diary. Participants who recorded rescue medication use within 24 hours post-dose were considered failures, where failure was the event being analyzed.	Percentage of Participants	NUMBER

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline in Facial Pain/Pressure/Fullness on NRS at 2 Hours Post-Dose	Rimegepant 75 mg	-2.70	95% Confidence Interval -3.16 to -2.25	Scores on a scale
Change From Baseline in Facial Pain/Pressure/Fullness on NRS at 2 Hours Post-Dose	Placebo	-2.61	95% Confidence Interval -3.06 to -2.17	Scores on a scale
Change From Baseline in Total Nasal Symptom Score (TNSS) at 2 Hours Post-Dose	Rimegepant 75 mg	-7.04	95% Confidence Interval -8.16 to -5.91	Scores on a scale
Change From Baseline in Total Nasal Symptom Score (TNSS) at 2 Hours Post-Dose	Placebo	-6.74	95% Confidence Interval -7.85 to -5.64	Scores on a scale
Change From Baseline in Nasal Obstruction (Congestion) at 2 Hours Post-Dose	Rimegepant 75 mg	-2.48	95% Confidence Interval -2.91 to -2.05	Scores on a scale
Change From Baseline in Nasal Obstruction (Congestion) at 2 Hours Post-Dose	Placebo	-2.25	95% Confidence Interval -2.67 to -1.82	Scores on a scale
Change From Baseline in Nasal Discharge at 2 Hours Post-Dose	Rimegepant 75 mg	-1.81	95% Confidence Interval -2.22 to -1.41	Scores on a scale
Change From Baseline in Nasal Discharge at 2 Hours Post-Dose	Placebo	-1.85	95% Confidence Interval -2.25 to -1.45	Scores on a scale
Percentage of Participants With Headache Pain Relief at 2 Hours Post-Dose	Rimegepant 75 mg	59.4	95% Confidence Interval 47.8 to 71.0	Percentage of Participants
Percentage of Participants With Headache Pain Relief at 2 Hours Post-Dose	Placebo	55.6	95% Confidence Interval 44.7 to 66.4	Percentage of Participants

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Rimegepant 75 mg	131
Overall Study	STARTED	Placebo	130
Overall Study	Treated	Rimegepant 75 mg	99
Overall Study	Treated	Placebo	105
Overall Study	COMPLETED	Rimegepant 75 mg	98
Overall Study	COMPLETED	Placebo	104
Overall Study	NOT COMPLETED	Rimegepant 75 mg	33
Overall Study	NOT COMPLETED	Placebo	26

Source ClinicalTrials.gov

Adverse events20

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Diarrhoea	Gastrointestinal disorders	Rimegepant	0	99
other	Diarrhoea	Gastrointestinal disorders	Placebo	1	105
other	Nausea	Gastrointestinal disorders	Rimegepant	0	99
other	Nausea	Gastrointestinal disorders	Placebo	1	105
other	Aspartate aminotransferase increased	Investigations	Rimegepant	1	99
other	Aspartate aminotransferase increased	Investigations	Placebo	0	105
other	Blood creatine phosphokinase increased	Investigations	Rimegepant	1	99
other	Blood creatine phosphokinase increased	Investigations	Placebo	0	105
other	Electrocardiogram PR shortened	Investigations	Rimegepant	0	99
other	Electrocardiogram PR shortened	Investigations	Placebo	1	105

1 to 10 of 20Source ClinicalTrials.gov

See all 20 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Rimegepant	0	99
Total, all-cause mortality	Placebo	0	105
Total, other adverse events	Rimegepant	4	99
Total, other adverse events	Placebo	5	105
Total, serious adverse events	Rimegepant	0	99
Total, serious adverse events	Placebo	0	105

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
41779821	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Rimegepant vs Placebo: deaths from any cause	Trial comparisons
Rimegepant vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT05248997

GET https://conductscience.org/api/trials/v1/NCT05248997/registered

API reference For AI assistants