Status:
COMPLETED
TI-001 (Intranasal Oxytocin) for Treatment of High Frequency Episodic Migraine and Chronic Migraine
Lead Sponsor:
Trigemina, Inc
Conditions:
High Frequency Episodic Migraine and Chronic Migraine
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This study evaluates the use of oxytocin, given as a nasal spray, for treatment of high frequency episodic migraine and chronic migraine.
Eligibility Criteria
Inclusion
- 1\. Men and women, aged 18 to 65 years with primary diagnosis of high frequency episodic migraine or chronic migraine.
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT01839149
Start Date
May 1 2013
End Date
January 1 2016
Last Update
May 13 2016
Active Locations (6)
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1
Fitzroy, Australia
2
Prahran, Australia
3
Sherwood, Australia
4
Santiago, Chile