Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of TNX-1900 in Patients With Chronic Migraine (NCT NCT05679908)

Last Updated: 2025-02-25

Results Overview

Mean change in the number of monthly migraine headache days from the last 28 days of Baseline to the last 28 days of treatment (ie, month 3). A migraine headache day is any calendar day (0:00 to 23:59) in which the patient records in the e-diary: * An attack lasting 4 hours or more and meeting the ICHD-3 criteria for migraine without aura, or * A migraine with aura, or * An attack that meets ICHD-3 criteria for probable migraine, (a migraine subtype fulfilling all but one criteria (B-D) for migraine without aura), or * An attack of any duration that was believed by the patient to be a migraine and was relieved by a triptan, ergot derivative, or other migraine-specific abortive medication.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

88 participants

Primary outcome timeframe

Last 28 days before Visit 2 (Day 1) and last 28 days before Visit 5 (Week 12)

Results posted on

2025-02-25

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Placebo taken intranasally twice daily. Placebo Nasal Spray: Patients will spray placebo nasal spray once into each nostril.	TNX-1900 Low Dose 30 IU oxytocin taken intranasally once daily. Placebo taken intranasally once daily. TNX-1900: Patients will spray TNX-1900 once into each nostril. Placebo Nasal Spray: Patients will spray placebo nasal spray once into each nostril.	TNX-1900 High Dose 30 IU oxytocin taken intranasally twice daily. TNX-1900: Patients will spray TNX-1900 once into each nostril.
Overall Study STARTED	27	31	30
Overall Study COMPLETED	25	26	27
Overall Study NOT COMPLETED	2	5	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Evaluate the Efficacy and Safety of TNX-1900 in Patients With Chronic Migraine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=27 Participants Placebo taken intranasally twice daily. Placebo Nasal Spray: Patients will spray placebo nasal spray once into each nostril.	TNX-1900 Low Dose n=31 Participants 30 IU oxytocin taken intranasally once daily. Placebo taken intranasally once daily. TNX-1900: Patients will spray TNX-1900 once into each nostril. Placebo Nasal Spray: Patients will spray placebo nasal spray once into each nostril.	TNX-1900 High Dose n=30 Participants 30 IU oxytocin taken intranasally twice daily. TNX-1900: Patients will spray TNX-1900 once into each nostril.	Total n=88 Participants Total of all reporting groups
Age, Continuous	42.2 years STANDARD_DEVIATION 10.61 • n=5 Participants	40.0 years STANDARD_DEVIATION 10.93 • n=7 Participants	44.1 years STANDARD_DEVIATION 11.43 • n=5 Participants	42.1 years STANDARD_DEVIATION 11.02 • n=4 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	12 Participants n=4 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	27 Participants n=7 Participants	28 Participants n=5 Participants	76 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	12 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=5 Participants	27 Participants n=7 Participants	28 Participants n=5 Participants	76 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 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	2 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	14 Participants n=4 Participants
Race (NIH/OMB) White	24 Participants n=5 Participants	22 Participants n=7 Participants	22 Participants n=5 Participants	68 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment United States	27 participants n=5 Participants	31 participants n=7 Participants	30 participants n=5 Participants	88 participants n=4 Participants

PRIMARY outcome

Timeframe: Last 28 days before Visit 2 (Day 1) and last 28 days before Visit 5 (Week 12)

Population: Data is reported for the mITT population, which includes all randomized patients who received at least one dose of study drug and had at least one post-Baseline evaluable month (that is, at least one of the three 28-day periods has at least 14 non-missing e-diary entries).

Outcome measures

Outcome measures
Measure	Placebo n=27 Participants Placebo taken intranasally twice daily. Placebo Nasal Spray: Patients will spray placebo nasal spray once into each nostril.	TNX-1900 Low Dose n=31 Participants 30 IU oxytocin taken intranasally once daily. Placebo taken intranasally once daily. TNX-1900: Patients will spray TNX-1900 once into each nostril. Placebo Nasal Spray: Patients will spray placebo nasal spray once into each nostril.	TNX-1900 High Dose n=29 Participants 30 IU oxytocin taken intranasally twice daily. TNX-1900: Patients will spray TNX-1900 once into each nostril.
Mean Change in the Number of Monthly Migraine Headache Days	-8.17 number of days Standard Error 1.366	-7.78 number of days Standard Error 1.246	-5.77 number of days Standard Error 1.301

SECONDARY outcome

Timeframe: Last 28 days before Visit 2 (Day 1) treatment and last 28 days before Visit 5 (Week 12)

Proportion of patients experiencing a ≥ 50% reduction in the number of migraine headache days from the last 28 days of Baseline to the last 28 days of treatment in each treatment group

Outcome measures

Outcome measures
Measure	Placebo n=27 Participants Placebo taken intranasally twice daily. Placebo Nasal Spray: Patients will spray placebo nasal spray once into each nostril.	TNX-1900 Low Dose n=31 Participants 30 IU oxytocin taken intranasally once daily. Placebo taken intranasally once daily. TNX-1900: Patients will spray TNX-1900 once into each nostril. Placebo Nasal Spray: Patients will spray placebo nasal spray once into each nostril.	TNX-1900 High Dose n=29 Participants 30 IU oxytocin taken intranasally twice daily. TNX-1900: Patients will spray TNX-1900 once into each nostril.
Proportion of Patients Experiencing a ≥ 50% Reduction in the Number of Migraine Headache Days	15 Participants	15 Participants	10 Participants

SECONDARY outcome

Timeframe: Last 28 days before Visit 2 (Day 1) treatment and last 28 days before Visit 5 (Week 12)

Mean change in the number of days using rescue medication (triptan, ergot derivative, or other migraine-specific acute medication) from the last 28 days of Baseline to the last 28 days of treatment.

Outcome measures

Outcome measures
Measure	Placebo n=27 Participants Placebo taken intranasally twice daily. Placebo Nasal Spray: Patients will spray placebo nasal spray once into each nostril.	TNX-1900 Low Dose n=31 Participants 30 IU oxytocin taken intranasally once daily. Placebo taken intranasally once daily. TNX-1900: Patients will spray TNX-1900 once into each nostril. Placebo Nasal Spray: Patients will spray placebo nasal spray once into each nostril.	TNX-1900 High Dose n=29 Participants 30 IU oxytocin taken intranasally twice daily. TNX-1900: Patients will spray TNX-1900 once into each nostril.
Mean Change in the Number of Days Using Rescue Medication	-3.16 days Standard Error .749	-4.09 days Standard Error .687	-2.07 days Standard Error .715

SECONDARY outcome

Timeframe: Visit 5 (Week 12)

Proportion of patients with a Patient Global Impression of Change (PGIC) of 1, "very much improved", or 2, "much improved", at Week 12. Scores range from 1 to 7. Lower scores indicate more improvement.

Outcome measures

Outcome measures
Measure	Placebo n=27 Participants Placebo taken intranasally twice daily. Placebo Nasal Spray: Patients will spray placebo nasal spray once into each nostril.	TNX-1900 Low Dose n=31 Participants 30 IU oxytocin taken intranasally once daily. Placebo taken intranasally once daily. TNX-1900: Patients will spray TNX-1900 once into each nostril. Placebo Nasal Spray: Patients will spray placebo nasal spray once into each nostril.	TNX-1900 High Dose n=29 Participants 30 IU oxytocin taken intranasally twice daily. TNX-1900: Patients will spray TNX-1900 once into each nostril.
Patient Global Impression of Change (PGIC)	12 Participants	16 Participants	14 Participants

SECONDARY outcome

Timeframe: Last 28 days before Visit 2 (Day 1) and last 28 days before Visit 5 (Week 12)

Mean change in the number of moderate or severe headache days from the last 28 days of Baseline to the last 28 days of treatment. A moderate or severe headache day is defined as any calendar day wherein a patient records a headache or migraine of moderate or severe peak intensity in the e-diary.

Outcome measures

Outcome measures
Measure	Placebo n=27 Participants Placebo taken intranasally twice daily. Placebo Nasal Spray: Patients will spray placebo nasal spray once into each nostril.	TNX-1900 Low Dose n=31 Participants 30 IU oxytocin taken intranasally once daily. Placebo taken intranasally once daily. TNX-1900: Patients will spray TNX-1900 once into each nostril. Placebo Nasal Spray: Patients will spray placebo nasal spray once into each nostril.	TNX-1900 High Dose n=29 Participants 30 IU oxytocin taken intranasally twice daily. TNX-1900: Patients will spray TNX-1900 once into each nostril.
Mean Change in the Number of Moderate or Severe Headache Days	-8.39 days Standard Error 1.372	-8.17 days Standard Error 1.236	-5.00 days Standard Error 1.304

SECONDARY outcome

Timeframe: Last 28 days before Visit 2 (Day 1) and average per 28 days over 12-week Treatment Period

Mean change in the number of migraine headache days from the last 28 days of Baseline to average number per 28 days over the entire 12-week duration of Treatment Period.

Outcome measures

Outcome measures
Measure	Placebo n=27 Participants Placebo taken intranasally twice daily. Placebo Nasal Spray: Patients will spray placebo nasal spray once into each nostril.	TNX-1900 Low Dose n=31 Participants 30 IU oxytocin taken intranasally once daily. Placebo taken intranasally once daily. TNX-1900: Patients will spray TNX-1900 once into each nostril. Placebo Nasal Spray: Patients will spray placebo nasal spray once into each nostril.	TNX-1900 High Dose n=29 Participants 30 IU oxytocin taken intranasally twice daily. TNX-1900: Patients will spray TNX-1900 once into each nostril.
Mean Change in the Number of Migraine Headache Days	-7.09 days Standard Error 1.208	-6.67 days Standard Error 1.063	-5.24 days Standard Error 1.146

SECONDARY outcome

Timeframe: Visit 2 (Day 1) and Visit 5 (Week 12)

Mean change from Baseline in the Migraine-Specific Quality of Life Questionnaire (MSQ v2.1) at Week 12. Scores range from 0 to 100. Higher scores indicate better quality of life.

Outcome measures

Outcome measures
Measure	Placebo n=27 Participants Placebo taken intranasally twice daily. Placebo Nasal Spray: Patients will spray placebo nasal spray once into each nostril.	TNX-1900 Low Dose n=31 Participants 30 IU oxytocin taken intranasally once daily. Placebo taken intranasally once daily. TNX-1900: Patients will spray TNX-1900 once into each nostril. Placebo Nasal Spray: Patients will spray placebo nasal spray once into each nostril.	TNX-1900 High Dose n=29 Participants 30 IU oxytocin taken intranasally twice daily. TNX-1900: Patients will spray TNX-1900 once into each nostril.
Mean Change From Baseline in the Migraine-Specific Quality of Life Questionnaire	26.07 units on a scale Standard Error 4.154	28.98 units on a scale Standard Error 3.727	21.10 units on a scale Standard Error 3.928

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

TNX-1900 Low Dose

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

TNX-1900 High Dose

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	Placebo n=27 participants at risk Placebo taken intranasally twice daily. Placebo Nasal Spray: Patients will spray placebo nasal spray once into each nostril.	TNX-1900 Low Dose n=31 participants at risk 30 IU oxytocin taken intranasally once daily. Placebo taken intranasally once daily. TNX-1900: Patients will spray TNX-1900 once into each nostril. Placebo Nasal Spray: Patients will spray placebo nasal spray once into each nostril.	TNX-1900 High Dose n=30 participants at risk 30 IU oxytocin taken intranasally twice daily. TNX-1900: Patients will spray TNX-1900 once into each nostril.
Respiratory, thoracic and mediastinal disorders Nasal discomfort	22.2% 6/27 • 12 weeks	32.3% 10/31 • 12 weeks	16.7% 5/30 • 12 weeks
Respiratory, thoracic and mediastinal disorders Nasal mucosal disorder	11.1% 3/27 • 12 weeks	16.1% 5/31 • 12 weeks	10.0% 3/30 • 12 weeks
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/27 • 12 weeks	6.5% 2/31 • 12 weeks	3.3% 1/30 • 12 weeks
Respiratory, thoracic and mediastinal disorders Rhinalgia	7.4% 2/27 • 12 weeks	0.00% 0/31 • 12 weeks	0.00% 0/30 • 12 weeks
Blood and lymphatic system disorders Neutropenia	0.00% 0/27 • 12 weeks	6.5% 2/31 • 12 weeks	0.00% 0/30 • 12 weeks
Nervous system disorders Migraine	0.00% 0/27 • 12 weeks	6.5% 2/31 • 12 weeks	0.00% 0/30 • 12 weeks
Product Issues Product after taste	0.00% 0/27 • 12 weeks	6.5% 2/31 • 12 weeks	0.00% 0/30 • 12 weeks

Additional Information

Gregory Sullivan

Tonix Pharmaceuticals

Phone: (862) 904-0355

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee An industry standard NDA is in place with all investigators.
Publication restrictions are in place

Restriction type: OTHER