CompletedPhase 2

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

Australia, Chile, New Zealand240 participantsStarted 2013-05

Plain-language summary

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

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✕. Known allergy to oxytocin
✕. History of addictive behavior (eg, alcoholism, drug abuse) or severe mood disorder
✕. History of clinically significant, functionally impairing cardiovascular or pulmonary disease or any other disease that might confound study results
✕. Have basilar or hemiplegic migraines
✕. Have substantial cognitive or memory impairment due to any cause (eg, Alzheimer's or dementia)
✕. Have a nasal obstruction due to any cause
✕. Are pregnant or breast feeding
✕. Require ongoing use of steroidal or nonsteroidal anti-inflammatory drugs

Mean change of migraine days

Timeframe: Baseline and 28 days of treatment

NCT IDNCT01839149

SponsorTrigemina, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-10