TI-001 (Intranasal Oxytocin) for Treatment of High Frequency Episodic Migraine and Chronic Migraine
NCT ID: NCT01839149
Last Updated: 2016-05-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
240 participants
INTERVENTIONAL
2013-05-31
2016-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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TI-001 (intranasal oxytocin)
TI-001 is intranasal oxytocin
TI-001
TI-001 is intranasal oxytocin
Placebo
Placebo for TI-001 is the same intranasal formulation without oxytocin
Placebo
Interventions
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TI-001
TI-001 is intranasal oxytocin
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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
18 Years
65 Years
ALL
No
Sponsors
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Trigemina, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Raquel Izumi, PhD
Role: STUDY_DIRECTOR
Trigemina, Inc
Locations
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Fitzroy, , Australia
Prahran, , Australia
Sherwood, , Australia
Santiago, , Chile
Tauranga, , New Zealand
Wellington, , New Zealand
Countries
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Other Identifiers
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TRIG-05
Identifier Type: -
Identifier Source: org_study_id
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