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

Phase 2

Completed

• Conditions: High Frequency Episodic Migraine and Chronic Migraine
• Interventions: Drug: TI-001; Drug: Placebo

• Registration Number: NCT01839149
• Lead Sponsor: Trigemina, Inc

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-04-17
• Study First Submitted QC: 2013-04-19
• Study First Posted: 2013-04-24
• Study Start: 2013-05
• Primary Completion: 2015-10
• Study Completion: 2016-01
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-11
• Last Update Posted: 2016-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TI-001 (intranasal oxytocin)	TI-001	TI-001 is intranasal oxytocin
Placebo	Placebo	Placebo for TI-001 is the same intranasal formulation without oxytocin

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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