Trial Outcomes & Findings for Study to Determine Safety and Efficacy of B244 in Subjects With Episodic Migraine (NCT NCT03488563)

NCT ID: NCT03488563

Last Updated: 2022-10-04

Results Overview

Safety and tolerability endpoints will consist of all adverse events reporting during the study duration.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

313 participants

Primary outcome timeframe

Baseline to Day 112

Results posted on

2022-10-04

Participant Flow

Participant milestones

Participant milestones
Measure	B244 Dose 1 B244 1X suspension (1x10E9 cells/ml) in 30ml/bottle Subjects will apply 1 pump per nostril twice-a-day B244: B244 Suspension	B244 Dose 2 B244 4X suspension (4x10E9 cells/ml) in 30ml/bottle Subjects will apply 1 pump per nostril twice-a-day B244: B244 Suspension	Vehicle Vehicle, 30ml/bottle Subjects will apply 1 pump per nostril twice-a-day Vehicle: Vehicle Suspension
Overall Study STARTED	105	104	104
Overall Study COMPLETED	83	88	81
Overall Study NOT COMPLETED	22	16	23

Reasons for withdrawal

Reasons for withdrawal
Measure	B244 Dose 1 B244 1X suspension (1x10E9 cells/ml) in 30ml/bottle Subjects will apply 1 pump per nostril twice-a-day B244: B244 Suspension	B244 Dose 2 B244 4X suspension (4x10E9 cells/ml) in 30ml/bottle Subjects will apply 1 pump per nostril twice-a-day B244: B244 Suspension	Vehicle Vehicle, 30ml/bottle Subjects will apply 1 pump per nostril twice-a-day Vehicle: Vehicle Suspension
Overall Study Lost to Follow-up	7	6	7
Overall Study Withdrawal by Subject	8	7	7
Overall Study Physician Decision	0	0	1
Overall Study Protocol Violation	3	2	6
Overall Study Subject did not meet minimum number of migraines per month	1	0	0
Overall Study Use of prohibited medication	2	0	0
Overall Study Adverse Event	1	0	1
Overall Study Subject returned for ET visit	0	1	0
Overall Study Sponsor's decision	0	0	1

Baseline Characteristics

Study to Determine Safety and Efficacy of B244 in Subjects With Episodic Migraine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	B244 Dose 1 n=92 Participants B244 1X suspension (1x10E9 cells/ml) in 30ml/bottle Subjects will apply 1 pump per nostril twice-a-day B244: B244 Suspension	B244 Dose 2 n=94 Participants B244 4X suspension (4x10E9 cells/ml) in 30ml/bottle Subjects will apply 1 pump per nostril twice-a-day B244: B244 Suspension	Vehicle n=88 Participants Vehicle, 30ml/bottle Subjects will apply 1 pump per nostril twice-a-day Vehicle: Vehicle Suspension	Total n=274 Participants Total of all reporting groups
Age, Customized <30	16 Participants n=5 Participants	12 Participants n=7 Participants	16 Participants n=5 Participants	44 Participants n=4 Participants
Age, Customized ≥30	76 Participants n=5 Participants	82 Participants n=7 Participants	72 Participants n=5 Participants	230 Participants n=4 Participants
Sex: Female, Male Female	82 Participants n=5 Participants	76 Participants n=7 Participants	76 Participants n=5 Participants	234 Participants n=4 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	18 Participants n=7 Participants	12 Participants n=5 Participants	40 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants	10 Participants n=7 Participants	14 Participants n=5 Participants	34 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	82 Participants n=5 Participants	84 Participants n=7 Participants	72 Participants n=5 Participants	238 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	27 Participants n=5 Participants	21 Participants n=7 Participants	20 Participants n=5 Participants	68 Participants n=4 Participants
Race (NIH/OMB) White	61 Participants n=5 Participants	69 Participants n=7 Participants	66 Participants n=5 Participants	196 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants
Weight	85.09 kg STANDARD_DEVIATION 25.835 • n=5 Participants	93.33 kg STANDARD_DEVIATION 22.791 • n=7 Participants	89.34 kg STANDARD_DEVIATION 25.940 • n=5 Participants	85.85 kg STANDARD_DEVIATION 24.903 • n=4 Participants
Height	1.66 m STANDARD_DEVIATION 0.084 • n=5 Participants	1.66 m STANDARD_DEVIATION 0.111 • n=7 Participants	1.66 m STANDARD_DEVIATION 0.089 • n=5 Participants	1.66 m STANDARD_DEVIATION 0.095 • n=4 Participants
BMI	30.51 kg/m^2 STANDARD_DEVIATION 8.569 • n=5 Participants	30.55 kg/m^2 STANDARD_DEVIATION 9.183 • n=7 Participants	31.99 kg/m^2 STANDARD_DEVIATION 8.229 • n=5 Participants	31.00 kg/m^2 STANDARD_DEVIATION 8.675 • n=4 Participants
BMI Category <20 kg/m^2	2 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	7 Participants n=4 Participants
BMI Category 20-<25 kg/m^2	23 Participants n=5 Participants	26 Participants n=7 Participants	17 Participants n=5 Participants	66 Participants n=4 Participants
BMI Category 25-<30 kg/m^2	30 Participants n=5 Participants	20 Participants n=7 Participants	19 Participants n=5 Participants	69 Participants n=4 Participants
BMI Category ≥30 kg/m^2	37 Participants n=5 Participants	45 Participants n=7 Participants	50 Participants n=5 Participants	132 Participants n=4 Participants
Smoking History Never	73 Participants n=5 Participants	66 Participants n=7 Participants	62 Participants n=5 Participants	201 Participants n=4 Participants
Smoking History Former	17 Participants n=5 Participants	19 Participants n=7 Participants	12 Participants n=5 Participants	48 Participants n=4 Participants
Smoking History Current	2 Participants n=5 Participants	9 Participants n=7 Participants	14 Participants n=5 Participants	25 Participants n=4 Participants
Number of Migraine Days	7.4 days STANDARD_DEVIATION 2.86 • n=5 Participants	7.4 days STANDARD_DEVIATION 2.71 • n=7 Participants	8.0 days STANDARD_DEVIATION 3.09 • n=5 Participants	7.6 days STANDARD_DEVIATION 2.89 • n=4 Participants
Number of Migraine Attacks	4.9 attacks STANDARD_DEVIATION 1.88 • n=5 Participants	5.0 attacks STANDARD_DEVIATION 1.46 • n=7 Participants	5.1 attacks STANDARD_DEVIATION 1.81 • n=5 Participants	5.0 attacks STANDARD_DEVIATION 1.72 • n=4 Participants
Number of Acute Migraine Specific Medication Days	5.5 days STANDARD_DEVIATION 3.60 • n=5 Participants	5.5 days STANDARD_DEVIATION 3.22 • n=7 Participants	6.1 days STANDARD_DEVIATION 3.85 • n=5 Participants	5.7 days STANDARD_DEVIATION 3.56 • n=4 Participants
Number of Moderate and Severe Headache Days	5.7 days STANDARD_DEVIATION 2.88 • n=5 Participants	6.2 days STANDARD_DEVIATION 3.00 • n=7 Participants	6.3 days STANDARD_DEVIATION 3.07 • n=5 Participants	6.1 days STANDARD_DEVIATION 2.98 • n=4 Participants
Number of Headache Days	8.3 days STANDARD_DEVIATION 3.04 • n=5 Participants	8.4 days STANDARD_DEVIATION 2.88 • n=7 Participants	9.3 days STANDARD_DEVIATION 3.44 • n=5 Participants	8.6 days STANDARD_DEVIATION 3.14 • n=4 Participants
Number of Headache Hours	97.0 hours STANDARD_DEVIATION 68.31 • n=5 Participants	96.4 hours STANDARD_DEVIATION 65.09 • n=7 Participants	107.7 hours STANDARD_DEVIATION 66.68 • n=5 Participants	100.2 hours STANDARD_DEVIATION 66.65 • n=4 Participants
MIDAS Score	30.3 units on a scale STANDARD_DEVIATION 24.23 • n=5 Participants	45.3 units on a scale STANDARD_DEVIATION 50.94 • n=7 Participants	40.1 units on a scale STANDARD_DEVIATION 50.58 • n=5 Participants	38.6 units on a scale STANDARD_DEVIATION 43.98 • n=4 Participants
HIT Score	63.0 units on a scale STANDARD_DEVIATION 5.77 • n=5 Participants	64.1 units on a scale STANDARD_DEVIATION 4.36 • n=7 Participants	63.9 units on a scale STANDARD_DEVIATION 4.86 • n=5 Participants	63.7 units on a scale STANDARD_DEVIATION 5.03 • n=4 Participants
MSQL Score - Role Function-Restrictive	48.1 units on a scale STANDARD_DEVIATION 18.88 • n=5 Participants	44.1 units on a scale STANDARD_DEVIATION 20.17 • n=7 Participants	45.6 units on a scale STANDARD_DEVIATION 20.65 • n=5 Participants	45.9 units on a scale STANDARD_DEVIATION 19.90 • n=4 Participants
MSQL Score - Role Function-Preventive	63.2 units on a scale STANDARD_DEVIATION 21.54 • n=5 Participants	60.3 units on a scale STANDARD_DEVIATION 22.92 • n=7 Participants	61.8 units on a scale STANDARD_DEVIATION 24.13 • n=5 Participants	61.8 units on a scale STANDARD_DEVIATION 22.82 • n=4 Participants
MSQL Score - Emotional Function	55.9 units on a scale STANDARD_DEVIATION 29.73 • n=5 Participants	50.5 units on a scale STANDARD_DEVIATION 27.23 • n=7 Participants	50.4 units on a scale STANDARD_DEVIATION 27.70 • n=5 Participants	52.3 units on a scale STANDARD_DEVIATION 28.25 • n=4 Participants

PRIMARY outcome

Timeframe: Baseline to Day 112

Population: Safety population included all subjects who received at least 1 dose of IP. Subjects were analyzed according to the IP received.

Safety and tolerability endpoints will consist of all adverse events reporting during the study duration.

Outcome measures

Outcome measures
Measure	B244 Dose 1 n=105 Participants B244 1X suspension (1x10E9 cells/ml) in 30ml/bottle Subjects will apply 1 pump per nostril twice-a-day B244: B244 Suspension	B244 Dose 2 n=104 Participants B244 4X suspension (4x10E9 cells/ml) in 30ml/bottle Subjects will apply 1 pump per nostril twice-a-day B244: B244 Suspension	Vehicle n=104 Participants Vehicle, 30ml/bottle Subjects will apply 1 pump per nostril twice-a-day Vehicle: Vehicle Suspension
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 At Least 1 Treatment-Related Grade 3 or 4 TEAE	1 Participants	0 Participants	1 Participants
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 At Least 1 Treatment-Related Serious TEAE	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 At Least 1 Treatment-Related TEAE	18 Participants	13 Participants	17 Participants

SECONDARY outcome

Timeframe: Baseline to Day 84

Population: Subjects from the Intent-to-Treat Population (all randomized subjects who received at least 1 dose of IP and had 80% ePRO diary compliance) that remained in the study up to Day 84 with data collected for the respective outcome measure. Subjects were analyzed according to the treatment assigned by the randomization schedule.

Subjects made daily entries to include recordings of migraine frequency, duration, and severity that included information on migraine days (experiencing migraine with or without aura in a given day).

Outcome measures

Outcome measures
Measure	B244 Dose 1 n=65 Participants B244 1X suspension (1x10E9 cells/ml) in 30ml/bottle Subjects will apply 1 pump per nostril twice-a-day B244: B244 Suspension	B244 Dose 2 n=68 Participants B244 4X suspension (4x10E9 cells/ml) in 30ml/bottle Subjects will apply 1 pump per nostril twice-a-day B244: B244 Suspension	Vehicle n=65 Participants Vehicle, 30ml/bottle Subjects will apply 1 pump per nostril twice-a-day Vehicle: Vehicle Suspension
Mean Change in Monthly Migraine Days.	-3.2 days per month Standard Deviation 4.53	-3.0 days per month Standard Deviation 4.04	-3.4 days per month Standard Deviation 3.77

SECONDARY outcome

Timeframe: Baseline to Day 84

Subjects made daily entries to include recordings of migraine frequency, duration, and severity that included information on migraine attacks (an episode of any qualified migraine headache. To distinguish an attack of long duration from two attacks or to distinguish between attacks and relapses: A migraine attack that is interrupted by sleep, or temporarily remits, and then recurs within 48 hours (i.e., \<48 hours between the start of the migraine attack to the time of the recurrence) will be considered as one attack and not two. -An attack treated successfully with medication but with relapse within 48 hours (i.e., \<48 hours between the start of the migraine attack to the time of recurrence) will be considered as one attack.)

Outcome measures

Outcome measures
Measure	B244 Dose 1 n=65 Participants B244 1X suspension (1x10E9 cells/ml) in 30ml/bottle Subjects will apply 1 pump per nostril twice-a-day B244: B244 Suspension	B244 Dose 2 n=68 Participants B244 4X suspension (4x10E9 cells/ml) in 30ml/bottle Subjects will apply 1 pump per nostril twice-a-day B244: B244 Suspension	Vehicle n=65 Participants Vehicle, 30ml/bottle Subjects will apply 1 pump per nostril twice-a-day Vehicle: Vehicle Suspension
Mean Change in Monthly Migraine Attacks.	-2.0 attacks Standard Deviation 2.83	-2.1 attacks Standard Deviation 2.43	-2.0 attacks Standard Deviation 2.69

SECONDARY outcome

Timeframe: Baseline to Day 112

Population: Subjects from the Intent-to-Treat Population (all randomized subjects who received at least 1 dose of IP and had 80% ePRO diary compliance) that remained in the study up to Day 112 with data collected for the respective outcome measure. Subjects were analyzed according to the treatment assigned by the randomization schedule.

Subjects made daily entries to include recordings of migraine frequency, duration, and severity that included information on migraine days (experiencing migraine with or without aura in a given day).

Outcome measures

Outcome measures
Measure	B244 Dose 1 n=65 Participants B244 1X suspension (1x10E9 cells/ml) in 30ml/bottle Subjects will apply 1 pump per nostril twice-a-day B244: B244 Suspension	B244 Dose 2 n=68 Participants B244 4X suspension (4x10E9 cells/ml) in 30ml/bottle Subjects will apply 1 pump per nostril twice-a-day B244: B244 Suspension	Vehicle n=65 Participants Vehicle, 30ml/bottle Subjects will apply 1 pump per nostril twice-a-day Vehicle: Vehicle Suspension
Proportion of Subjects Experiencing a 50%, 75%, and 100% Reduction in Monthly Migraine Days. Week 12 : ≥50% Reduction	31 Participants	36 Participants	32 Participants
Proportion of Subjects Experiencing a 50%, 75%, and 100% Reduction in Monthly Migraine Days. Week 12 : ≥75% Reduction	20 Participants	17 Participants	17 Participants
Proportion of Subjects Experiencing a 50%, 75%, and 100% Reduction in Monthly Migraine Days. Week 12 : 100% Reduction	10 Participants	8 Participants	7 Participants
Proportion of Subjects Experiencing a 50%, 75%, and 100% Reduction in Monthly Migraine Days. Week 16 : ≥50% Reduction	24 Participants	20 Participants	20 Participants
Proportion of Subjects Experiencing a 50%, 75%, and 100% Reduction in Monthly Migraine Days. Week 16 : ≥75% Reduction	12 Participants	7 Participants	12 Participants
Proportion of Subjects Experiencing a 50%, 75%, and 100% Reduction in Monthly Migraine Days. Week 16 : 100% Reduction	10 Participants	3 Participants	3 Participants

SECONDARY outcome

Timeframe: Baseline to Day 84

Subjects made daily entries to include recordings of migraine frequency, duration, and severity that included use of rescue (acute migraine specific) medications and dosing administration.

Outcome measures

Outcome measures
Measure	B244 Dose 1 n=65 Participants B244 1X suspension (1x10E9 cells/ml) in 30ml/bottle Subjects will apply 1 pump per nostril twice-a-day B244: B244 Suspension	B244 Dose 2 n=68 Participants B244 4X suspension (4x10E9 cells/ml) in 30ml/bottle Subjects will apply 1 pump per nostril twice-a-day B244: B244 Suspension	Vehicle n=65 Participants Vehicle, 30ml/bottle Subjects will apply 1 pump per nostril twice-a-day Vehicle: Vehicle Suspension
Mean Change in Monthly Acute Migraine Specific Medication Days.	-2.0 days Standard Deviation 5.62	-2.5 days Standard Deviation 3.70	-2.9 days Standard Deviation 4.26

SECONDARY outcome

Timeframe: Baseline to Day 84

Subjects made daily entries to include recordings of migraine frequency, duration, and severity that included information on headache days (a non-migraine headache day)

Outcome measures

Outcome measures
Measure	B244 Dose 1 n=65 Participants B244 1X suspension (1x10E9 cells/ml) in 30ml/bottle Subjects will apply 1 pump per nostril twice-a-day B244: B244 Suspension	B244 Dose 2 n=68 Participants B244 4X suspension (4x10E9 cells/ml) in 30ml/bottle Subjects will apply 1 pump per nostril twice-a-day B244: B244 Suspension	Vehicle n=65 Participants Vehicle, 30ml/bottle Subjects will apply 1 pump per nostril twice-a-day Vehicle: Vehicle Suspension
Mean Change in Monthly Headache Days.	-3.5 days Standard Deviation 4.66	-3.4 days Standard Deviation 3.96	-4.2 days Standard Deviation 3.79

SECONDARY outcome

Timeframe: Baseline to Day 84

The Migraine Disability Assessment (MIDAS) questionnaire was administered to study examine the relationship between the impact of migraine and quality of life where subjects scored 5 questions on a scale of 0 to 21+ (0-5=little or no disability, 6-10=mild disability, 11-20=moderate disability, 21+=severe disability). The total score ranges from 0 to 90.

Outcome measures

Outcome measures
Measure	B244 Dose 1 n=77 Participants B244 1X suspension (1x10E9 cells/ml) in 30ml/bottle Subjects will apply 1 pump per nostril twice-a-day B244: B244 Suspension	B244 Dose 2 n=82 Participants B244 4X suspension (4x10E9 cells/ml) in 30ml/bottle Subjects will apply 1 pump per nostril twice-a-day B244: B244 Suspension	Vehicle n=72 Participants Vehicle, 30ml/bottle Subjects will apply 1 pump per nostril twice-a-day Vehicle: Vehicle Suspension
Mean Change From Baseline to 12 Weeks of Treatment in Disability, as Measured by the Migraine Disability Assessment (MIDAS)	-10.0 score on a scale Standard Deviation 24.83	-18.0 score on a scale Standard Deviation 39.43	-13.8 score on a scale Standard Deviation 23.82

SECONDARY outcome

Timeframe: Baseline to Day 84

The Headache Impact Test-6 (HIT-6) questionnaire was administered to examine the relationship between impact of migraine and quality of life. The total score ranges from 36 to 78 where a higher score indicates a greater impact on quality of life (Class I: 36-49, Class II: 50-55, Class III: 56-59, Class IV: 60+).

Outcome measures

Outcome measures
Measure	B244 Dose 1 n=75 Participants B244 1X suspension (1x10E9 cells/ml) in 30ml/bottle Subjects will apply 1 pump per nostril twice-a-day B244: B244 Suspension	B244 Dose 2 n=80 Participants B244 4X suspension (4x10E9 cells/ml) in 30ml/bottle Subjects will apply 1 pump per nostril twice-a-day B244: B244 Suspension	Vehicle n=72 Participants Vehicle, 30ml/bottle Subjects will apply 1 pump per nostril twice-a-day Vehicle: Vehicle Suspension
Mean Change From Baseline to 12 Weeks of Treatment in Monthly Headache Impact Test-6 (HIT-6) Questionnaire	-4.3 score on a scale Standard Deviation 6.72	-6.2 score on a scale Standard Deviation 7.68	-5.7 score on a scale Standard Deviation 7.54

SECONDARY outcome

Timeframe: Baseline to Day 84

The Migraine Specific Quality of Life (MSQL) questionnaire was used to examine the impact of migraine on health-related quality of life across three domains: Role Function-Restrictive (7 questions) examines the degree to which performance of daily activities is limited by migraine; Role Function-Preventive (4 questions) examines the degree to which performance of daily activities is prevented by migraine; Emotional Function (3 questions) examines feelings of frustration and helplessness due to migraine. Total score for each domain ranges from 0 to 100, where a higher score indicates greater severity.

Outcome measures

Outcome measures
Measure	B244 Dose 1 n=76 Participants B244 1X suspension (1x10E9 cells/ml) in 30ml/bottle Subjects will apply 1 pump per nostril twice-a-day B244: B244 Suspension	B244 Dose 2 n=82 Participants B244 4X suspension (4x10E9 cells/ml) in 30ml/bottle Subjects will apply 1 pump per nostril twice-a-day B244: B244 Suspension	Vehicle n=72 Participants Vehicle, 30ml/bottle Subjects will apply 1 pump per nostril twice-a-day Vehicle: Vehicle Suspension
Mean Change From Baseline to 12 Weeks of Treatment in Monthly Migraine Specific Quality of Life Questionnaire (MSQL) Role Function-Restrictive	15.5 score on a scale Standard Deviation 18.00	22.7 score on a scale Standard Deviation 23.69	22.3 score on a scale Standard Deviation 24.53
Mean Change From Baseline to 12 Weeks of Treatment in Monthly Migraine Specific Quality of Life Questionnaire (MSQL) Role Function-Preventive	10.7 score on a scale Standard Deviation 16.89	16.1 score on a scale Standard Deviation 22.21	12.5 score on a scale Standard Deviation 22.04
Mean Change From Baseline to 12 Weeks of Treatment in Monthly Migraine Specific Quality of Life Questionnaire (MSQL) Emotional Function	11.8 score on a scale Standard Deviation 24.77	19.0 score on a scale Standard Deviation 27.16	20.2 score on a scale Standard Deviation 27.95

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to Day 112

Population: Subjects from the Intent-to-Treat Population (all randomized subjects who received at least 1 dose of IP and had 80% ePRO diary compliance) that remained in the study up to Day 112 with data collected for the respective outcome measure. Subjects were analyzed according to the treatment assigned by the randomization schedule.

Subjects made daily entries to include recordings of migraine frequency, duration, and severity that included information on migraine associated symptoms: nausea/vomiting, photophobia and sonophobia.

Outcome measures

Outcome measures
Measure	B244 Dose 1 n=65 Participants B244 1X suspension (1x10E9 cells/ml) in 30ml/bottle Subjects will apply 1 pump per nostril twice-a-day B244: B244 Suspension	B244 Dose 2 n=68 Participants B244 4X suspension (4x10E9 cells/ml) in 30ml/bottle Subjects will apply 1 pump per nostril twice-a-day B244: B244 Suspension	Vehicle n=65 Participants Vehicle, 30ml/bottle Subjects will apply 1 pump per nostril twice-a-day Vehicle: Vehicle Suspension
Mean Change in Days Where Subject Recorded Migraine Associated Symptoms: Nausea/Vomiting, Photophobia and Sonophobia. Change from Baseline to Week 12	-2.3 days Standard Deviation 4.68	-2.8 days Standard Deviation 3.49	-2.9 days Standard Deviation 3.56
Mean Change in Days Where Subject Recorded Migraine Associated Symptoms: Nausea/Vomiting, Photophobia and Sonophobia. Change from Baseline to Week 16	-1.6 days Standard Deviation 4.61	-2.0 days Standard Deviation 3.93	-1.6 days Standard Deviation 4.21

Adverse Events

B244 Dose 1

Serious events: 3 serious events

Other events: 45 other events

Deaths: 0 deaths

B244 Dose 2

Serious events: 0 serious events

Other events: 42 other events

Deaths: 0 deaths

Vehicle

Serious events: 0 serious events

Other events: 49 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	B244 Dose 1 n=105 participants at risk B244 1X suspension (1x10E9 cells/ml) in 30ml/bottle Subjects will apply 1 pump per nostril twice-a-day B244: B244 Suspension	B244 Dose 2 n=104 participants at risk B244 4X suspension (4x10E9 cells/ml) in 30ml/bottle Subjects will apply 1 pump per nostril twice-a-day B244: B244 Suspension	Vehicle n=104 participants at risk Vehicle, 30ml/bottle Subjects will apply 1 pump per nostril twice-a-day Vehicle: Vehicle Suspension
Hepatobiliary disorders Cholelithiasis	0.95% 1/105 • Baseline to Day 112 All AEs occurring after administration of the first dose of IP and on or before the final assessment were to be reported. All AEs were to be recorded irrespective of whether they were considered drug-related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. All SAEs were to be reported immediately by the Investigator.	0.00% 0/104 • Baseline to Day 112 All AEs occurring after administration of the first dose of IP and on or before the final assessment were to be reported. All AEs were to be recorded irrespective of whether they were considered drug-related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. All SAEs were to be reported immediately by the Investigator.	0.00% 0/104 • Baseline to Day 112 All AEs occurring after administration of the first dose of IP and on or before the final assessment were to be reported. All AEs were to be recorded irrespective of whether they were considered drug-related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. All SAEs were to be reported immediately by the Investigator.
Respiratory, thoracic and mediastinal disorders Asthma	1.9% 2/105 • Baseline to Day 112 All AEs occurring after administration of the first dose of IP and on or before the final assessment were to be reported. All AEs were to be recorded irrespective of whether they were considered drug-related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. All SAEs were to be reported immediately by the Investigator.	0.00% 0/104 • Baseline to Day 112 All AEs occurring after administration of the first dose of IP and on or before the final assessment were to be reported. All AEs were to be recorded irrespective of whether they were considered drug-related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. All SAEs were to be reported immediately by the Investigator.	0.00% 0/104 • Baseline to Day 112 All AEs occurring after administration of the first dose of IP and on or before the final assessment were to be reported. All AEs were to be recorded irrespective of whether they were considered drug-related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. All SAEs were to be reported immediately by the Investigator.

Other adverse events

Additional Information

Hyun Kim, Vice President Clinical Operations

AOBiome Therapeutics

Phone: 617-639-9980

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor shall have 45 days to review the papers. Sponsor shall have the right to require Institution/Principal Investigator, as applicable, to remove specifically identified confidential information and/or delay the proposed publication or presentation for an additional one hundred twenty (120) days to enable Sponsor to seek patent protections.
Publication restrictions are in place

Restriction type: OTHER