TI-001 (Intranasal Oxytocin) for Treatment of High Frequency Episodic Migraine and Chronic Migraine
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
1 other identifier
interventional
240
3 countries
6
Brief Summary
This study evaluates the use of oxytocin, given as a nasal spray, for treatment of high frequency episodic migraine and chronic migraine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2013
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 17, 2013
CompletedFirst Posted
Study publicly available on registry
April 24, 2013
CompletedStudy Start
First participant enrolled
May 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedMay 13, 2016
May 1, 2016
2.4 years
April 17, 2013
May 11, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean change of migraine days
Baseline is the 28-day screening period before study drug administration
Baseline and 28 days of treatment
Secondary Outcomes (4)
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
Study Arms (2)
TI-001 (intranasal oxytocin)
EXPERIMENTALTI-001 is intranasal oxytocin
Placebo
PLACEBO COMPARATORPlacebo for TI-001 is the same intranasal formulation without oxytocin
Interventions
Eligibility Criteria
You may qualify if:
- \. Men and women, aged 18 to 65 years with primary diagnosis of high frequency episodic migraine or chronic migraine.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Trigemina, Inclead
Study Sites (6)
Unknown Facility
Fitzroy, Australia
Unknown Facility
Prahran, Australia
Unknown Facility
Sherwood, Australia
Unknown Facility
Santiago, Chile
Unknown Facility
Tauranga, New Zealand
Unknown Facility
Wellington, New Zealand
Study Officials
- STUDY DIRECTOR
Raquel Izumi, PhD
Trigemina, Inc
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2013
First Posted
April 24, 2013
Study Start
May 1, 2013
Primary Completion
October 1, 2015
Study Completion
January 1, 2016
Last Updated
May 13, 2016
Record last verified: 2016-05