NCT05679908Phase 2Completed

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

Study sponsor: Tonix Pharmaceuticals, Inc.

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2023-10-08Actual

Enrollment · participants88Actual

Source updated2025-02-25Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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No recorded changes are available for this view and time period. Our history may be incomplete; this does not establish that the trial stayed unchanged.

Study details

Conditions studied

Chronic Migraine; Chronic Migraine, Headache; Chronic Migraine Without Aura; Aura Migraine

Treatments or interventions studied

TNX-1900DrugAlso known as intranasal oxytocin
Placebo Nasal SprayDrug

Primary outcomes · main study measures

Read the study measures

measure: Mean Change in the Number of Monthly Migraine Headache Days; description: 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.; timeFrame: Last 28 days before Visit 2 (Day 1) and last 28 days before Visit 5 (Week 12)

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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