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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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23 May 2016 |
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Main ID: |
NCT01839149 |
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Date of registration:
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17/04/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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TI-001 (Intranasal Oxytocin) for Treatment of High Frequency Episodic Migraine and Chronic Migraine
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Scientific 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 |
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Date of first enrolment:
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May 2013 |
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Target sample size:
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240 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01839149 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Australia
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Chile
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New Zealand
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Contacts
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Name:
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Raquel Izumi, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Trigemina, Inc |
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Key inclusion & exclusion 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:
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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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High Frequency Episodic Migraine and Chronic Migraine
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Intervention(s)
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Drug: TI-001
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Drug: Placebo
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Primary Outcome(s)
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Mean change of migraine days
[Time Frame: Baseline and 28 days of treatment]
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Secondary Outcome(s)
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Mean change in days using rescue medication
[Time Frame: Baseline and 28 days of treatment]
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Mean change of moderate or severe headache days
[Time Frame: Baseline and 28 days of treatment]
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Proportion of subjects experiencing a =50% reduction in migraine days
[Time Frame: Baseline and 28 days of treatment]
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Proportion of subjects experiencing a reduction in headache severity and pain score 2 hours after dosing
[Time Frame: Baseline and 28 days of treatment]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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