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
Sponsor study identifier
interventional
240
3 countries
6
Study Start
May 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2015
Actual (reported)Study Completion
January 2016
Actual (reported)This study evaluates the use of oxytocin, given as a nasal spray, for treatment of high frequency episodic migraine and chronic migraine.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2016
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 17, 2013
Actual (reported)April 24, 2013
Actual (reported)May 2013
Date type not reportedThis date has not been verified as actual or estimated.
October 2015
Actual (reported)January 2016
Actual (reported)Mean change of migraine days
Baseline is the 28-day screening period before study drug administration
Baseline and 28 days of treatment
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
TI-001 is intranasal oxytocin
Placebo for TI-001 is the same intranasal formulation without oxytocin
Fitzroy, Australia
Prahran, Australia
Sherwood, Australia
Santiago, Chile
Tauranga, New Zealand
Wellington, New Zealand
Raquel Izumi, PhD
Trigemina, Inc
240 participants (actual enrollment reported by the registry).
First Submitted
April 17, 2013
First Posted
April 24, 2013
Study Start
May 2013
Date type not reportedThis date has not been verified as actual or estimated.
Intranasal Oxytocin for the Treatment of Children and Adolescents With Autism Spectrum Disorders (ASD)
Contact the study team to confirm eligibility.
Primary Completion
October 2015
Actual (reported)Study Completion
January 2016
Actual (reported)Last Updated
May 13, 2016
Record last verified: 2016-05
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Source: ClinicalTrials.gov.
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