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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

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

Exclusion criteria

. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mean change of migraine days

Timeframe: Baseline and 28 days of treatment

Trial details

NCT IDNCT01839149

SponsorTrigemina, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-10

View on ClinicalTrials.gov More High Frequency Episodic Migraine and Chronic Migraine trials