TI-001 (Intranasal Oxytocin) for Treatment of High Frequency Episodic Migraine and Chronic Migraine

A Phase 2, Enriched-enrollment, Randomized-withdrawal, Double-blinded, Placebo-Controlled Study to Assess the Efficacy, Tolerability, and Safety of Intranasal Oxytocin in Subjects With Chronic Migraine

This study evaluates the use of oxytocin, given as a nasal spray, for treatment of high frequency episodic migraine and chronic migraine.

Inclusion Criteria:

1. Men and women, aged 18 to 65 years with primary diagnosis of high frequency episodic migraine or chronic migraine.

Exclusion Criteria:

1. Known allergy to oxytocin
2. History of addictive behavior (eg, alcoholism, drug abuse) or severe mood disorder
3. History of clinically significant, functionally impairing cardiovascular or pulmonary disease or any other disease that might confound study results
4. Have basilar or hemiplegic migraines
5. Have substantial cognitive or memory impairment due to any cause (eg, Alzheimer's or dementia)
6. Have a nasal obstruction due to any cause
7. Are pregnant or breast feeding
8. Require ongoing use of steroidal or nonsteroidal anti-inflammatory drugs
9. Are unable or unwilling to provide informed consent or to follow study procedures