Trial Outcomes & Findings for Safety and Efficacy of BHV-3000 (Rimegepant) Orally Disintegrating Tablet for the Acute Treatment of Chronic Rhinosinusitis (NCT NCT05248997)

Last Updated: 2025-03-26

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

261 participants

Primary outcome timeframe

Baseline, 2 hours post-dose

Results posted on

2025-03-26

Participant Flow

A total of 261 participants were enrolled and randomized in the study. Amongst which 99 received rimegepant and 105 received placebo.

Participants were to administer one dose of study medication only when participant had a facial pain/pressure/fullness that reached intensity of greater than or equal to (\>=) 6 on the numeric rating scale (NRS, 0 to 10) and they had completed pre-dose assessments in electronic (e)-diary. Study medication was to be administered only within 45 days of randomization.

Participant milestones

Participant milestones
Measure	Rimegepant 75 mg Participants were randomized for administration of rimegepant 75 mg, single dose, orally, as an orally disintegrating tablet (ODT) sublingually.	Placebo Participants were randomized for administration of placebo (matched to rimegepant), single dose, orally, as an ODT sublingually.
Overall Study STARTED	131	130
Overall Study Treated	99	105
Overall Study COMPLETED	98	104
Overall Study NOT COMPLETED	33	26

Reasons for withdrawal

Reasons for withdrawal
Measure	Rimegepant 75 mg Participants were randomized for administration of rimegepant 75 mg, single dose, orally, as an orally disintegrating tablet (ODT) sublingually.	Placebo Participants were randomized for administration of placebo (matched to rimegepant), single dose, orally, as an ODT sublingually.
Overall Study Lost to Follow-up	1	1
Overall Study Randomized but not treated	32	25

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rimegepant 75 mg n=131 Participants Participants were randomized for administration of rimegepant 75 mg, single dose, orally, as an ODT sublingually.	Placebo n=130 Participants Participants were randomized for administration of placebo (matched to rimegepant), single dose, orally, as an ODT sublingually.	Total n=261 Participants Total of all reporting groups
Age, Continuous	48.6 Years STANDARD_DEVIATION 15.27 • n=5 Participants	49.9 Years STANDARD_DEVIATION 15.83 • n=7 Participants	49.3 Years STANDARD_DEVIATION 15.53 • n=5 Participants
Sex: Female, Male Female	77 Participants n=5 Participants	68 Participants n=7 Participants	145 Participants n=5 Participants
Sex: Female, Male Male	54 Participants n=5 Participants	62 Participants n=7 Participants	116 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	27 Participants n=5 Participants	36 Participants n=7 Participants	63 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	102 Participants n=5 Participants	93 Participants n=7 Participants	195 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	19 Participants n=5 Participants	17 Participants n=7 Participants	36 Participants n=5 Participants
Race (NIH/OMB) White	106 Participants n=5 Participants	105 Participants n=7 Participants	211 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 2 hours post-dose

Population: 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.

Outcome measures

Outcome measures
Measure	Rimegepant 75 mg n=89 Participants Participants were randomized for administration of rimegepant 75 mg, single dose, orally, as an ODT sublingually.	Placebo n=92 Participants Participants were randomized for administration of placebo (matched to rimegepant), single dose, orally, as an ODT sublingually.
Change From Baseline in Facial Pain/Pressure/Fullness on NRS at 2 Hours Post-Dose	-2.70 Scores on a scale Interval -3.16 to -2.25	-2.61 Scores on a scale Interval -3.06 to -2.17

SECONDARY outcome

Timeframe: Baseline, 2 hours post-dose

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Rimegepant 75 mg n=89 Participants Participants were randomized for administration of rimegepant 75 mg, single dose, orally, as an ODT sublingually.	Placebo n=92 Participants Participants were randomized for administration of placebo (matched to rimegepant), single dose, orally, as an ODT sublingually.
Change From Baseline in Total Nasal Symptom Score (TNSS) at 2 Hours Post-Dose	-7.04 Scores on a scale Interval -8.16 to -5.91	-6.74 Scores on a scale Interval -7.85 to -5.64

SECONDARY outcome

Timeframe: Baseline, 2 hours post-dose

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Rimegepant 75 mg n=89 Participants Participants were randomized for administration of rimegepant 75 mg, single dose, orally, as an ODT sublingually.	Placebo n=92 Participants Participants were randomized for administration of placebo (matched to rimegepant), single dose, orally, as an ODT sublingually.
Change From Baseline in Nasal Obstruction (Congestion) at 2 Hours Post-Dose	-2.48 Scores on a scale Interval -2.91 to -2.05	-2.25 Scores on a scale Interval -2.67 to -1.82

SECONDARY outcome

Timeframe: Baseline, 2 hours post-dose

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Rimegepant 75 mg n=89 Participants Participants were randomized for administration of rimegepant 75 mg, single dose, orally, as an ODT sublingually.	Placebo n=92 Participants Participants were randomized for administration of placebo (matched to rimegepant), single dose, orally, as an ODT sublingually.
Change From Baseline in Nasal Discharge at 2 Hours Post-Dose	-1.81 Scores on a scale Interval -2.22 to -1.41	-1.85 Scores on a scale Interval -2.25 to -1.45

SECONDARY outcome

Timeframe: 2 hours post-dose

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Rimegepant 75 mg n=69 Participants Participants were randomized for administration of rimegepant 75 mg, single dose, orally, as an ODT sublingually.	Placebo n=81 Participants Participants were randomized for administration of placebo (matched to rimegepant), single dose, orally, as an ODT sublingually.
Percentage of Participants With Headache Pain Relief at 2 Hours Post-Dose	59.4 Percentage of Participants Interval 47.8 to 71.0	55.6 Percentage of Participants Interval 44.7 to 66.4

SECONDARY outcome

Timeframe: Through 24 hours post-dose

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Rimegepant 75 mg n=96 Participants Participants were randomized for administration of rimegepant 75 mg, single dose, orally, as an ODT sublingually.	Placebo n=100 Participants Participants were randomized for administration of placebo (matched to rimegepant), single dose, orally, as an ODT sublingually.
Percentage of Participants Who Used Rescue Medication Within 24 Hours Post-dose	7.3 Percentage of Participants Interval 2.1 to 12.5	10.0 Percentage of Participants Interval 4.1 to 15.9

Adverse Events

Rimegepant

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Rimegepant n=99 participants at risk Participants received one dose of Rimegepant at a dose of 75 mg, orally, as an ODT for the acute treatment of CRS with or without nasal polyps.	Placebo n=105 participants at risk Participants received one dose of Rimegepant matching placebo, orally, as an ODT for the acute treatment of CRS with or without nasal polyps.
Gastrointestinal disorders Diarrhoea	0.00% 0/99 • Within 7 (+2) days post single administration of study medication (single dose was to be administered on any day from randomization to 45 days post randomization) Safety analysis set was evaluated.	0.95% 1/105 • Within 7 (+2) days post single administration of study medication (single dose was to be administered on any day from randomization to 45 days post randomization) Safety analysis set was evaluated.
Gastrointestinal disorders Nausea	0.00% 0/99 • Within 7 (+2) days post single administration of study medication (single dose was to be administered on any day from randomization to 45 days post randomization) Safety analysis set was evaluated.	0.95% 1/105 • Within 7 (+2) days post single administration of study medication (single dose was to be administered on any day from randomization to 45 days post randomization) Safety analysis set was evaluated.
Investigations Aspartate aminotransferase increased	1.0% 1/99 • Within 7 (+2) days post single administration of study medication (single dose was to be administered on any day from randomization to 45 days post randomization) Safety analysis set was evaluated.	0.00% 0/105 • Within 7 (+2) days post single administration of study medication (single dose was to be administered on any day from randomization to 45 days post randomization) Safety analysis set was evaluated.
Investigations Blood creatine phosphokinase increased	1.0% 1/99 • Within 7 (+2) days post single administration of study medication (single dose was to be administered on any day from randomization to 45 days post randomization) Safety analysis set was evaluated.	0.00% 0/105 • Within 7 (+2) days post single administration of study medication (single dose was to be administered on any day from randomization to 45 days post randomization) Safety analysis set was evaluated.
Investigations Electrocardiogram PR shortened	0.00% 0/99 • Within 7 (+2) days post single administration of study medication (single dose was to be administered on any day from randomization to 45 days post randomization) Safety analysis set was evaluated.	0.95% 1/105 • Within 7 (+2) days post single administration of study medication (single dose was to be administered on any day from randomization to 45 days post randomization) Safety analysis set was evaluated.
Hepatobiliary disorders Hypertransaminasaemia	0.00% 0/99 • Within 7 (+2) days post single administration of study medication (single dose was to be administered on any day from randomization to 45 days post randomization) Safety analysis set was evaluated.	0.95% 1/105 • Within 7 (+2) days post single administration of study medication (single dose was to be administered on any day from randomization to 45 days post randomization) Safety analysis set was evaluated.
Infections and infestations Upper respiratory tract infection	1.0% 1/99 • Within 7 (+2) days post single administration of study medication (single dose was to be administered on any day from randomization to 45 days post randomization) Safety analysis set was evaluated.	0.00% 0/105 • Within 7 (+2) days post single administration of study medication (single dose was to be administered on any day from randomization to 45 days post randomization) Safety analysis set was evaluated.
Injury, poisoning and procedural complications Head injury	1.0% 1/99 • Within 7 (+2) days post single administration of study medication (single dose was to be administered on any day from randomization to 45 days post randomization) Safety analysis set was evaluated.	0.00% 0/105 • Within 7 (+2) days post single administration of study medication (single dose was to be administered on any day from randomization to 45 days post randomization) Safety analysis set was evaluated.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/99 • Within 7 (+2) days post single administration of study medication (single dose was to be administered on any day from randomization to 45 days post randomization) Safety analysis set was evaluated.	0.95% 1/105 • Within 7 (+2) days post single administration of study medication (single dose was to be administered on any day from randomization to 45 days post randomization) Safety analysis set was evaluated.
Respiratory, thoracic and mediastinal disorders Dry throat	1.0% 1/99 • Within 7 (+2) days post single administration of study medication (single dose was to be administered on any day from randomization to 45 days post randomization) Safety analysis set was evaluated.	0.00% 0/105 • Within 7 (+2) days post single administration of study medication (single dose was to be administered on any day from randomization to 45 days post randomization) Safety analysis set was evaluated.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
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