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

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

Official Title
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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

Conditions
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High Frequency Episodic Migraine and Chronic Migraine

Intervention / Treatment
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* Drug: TI-001
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Men and women, aged 18 to 65 years with primary diagnosis of high frequency episodic migraine or chronic migraine. 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 Are unable or unwilling to provide informed consent or to follow study procedures

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TI-001 (intranasal oxytocin)<br>TI-001 is intranasal oxytocin | Drug: TI-001<br>* TI-001 is intranasal oxytocin<br>* Other names: Intranasal oxytocin;|
| Placebo Comparator: Placebo<br>Placebo for TI-001 is the same intranasal formulation without oxytocin | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Refractory Chronic Migraine, Medically Intractable Chronic Migraine, Oxytocin, Intranasal oxytocin