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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01839149

Enrollment

240

Registered

2013-04-24

Start date

2013-05-31

Completion date

2016-01-31

Last updated

2016-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High Frequency Episodic Migraine and Chronic Migraine

Keywords

Refractory Chronic Migraine, Medically Intractable Chronic Migraine, Oxytocin, Intranasal oxytocin

Brief summary

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

Interventions

DRUGTI-001

TI-001 is intranasal oxytocin

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Mean change of migraine days	Baseline and 28 days of treatment	Baseline is the 28-day screening period before study drug administration

Secondary

Measure	Time frame
Mean change of moderate or severe headache days	Baseline and 28 days of treatment
Proportion of subjects experiencing a ≥50% reduction in migraine days	Baseline and 28 days of treatment
Mean change in days using rescue medication	Baseline and 28 days of treatment
Proportion of subjects experiencing a reduction in headache severity and pain score 2 hours after dosing	Baseline and 28 days of treatment

Countries

Australia, Chile, New Zealand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026