Back to resultsTI-001 (Intranasal Oxytocin) for Treatment of High Frequency Episodic Migraine and Chronic Migraine
Primary Purpose
High Frequency Episodic Migraine and Chronic Migraine
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
TI-001
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for High Frequency Episodic Migraine and Chronic Migraine focused on measuring Refractory Chronic Migraine, Medically Intractable Chronic Migraine, Oxytocin, Intranasal oxytocin
Eligibility Criteria
Inclusion Criteria:
1. Men and women, aged 18 to 65 years with primary diagnosis of high frequency episodic migraine or chronic migraine.
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
TI-001 (intranasal oxytocin)
Placebo
Arm Description
TI-001 is intranasal oxytocin
Placebo for TI-001 is the same intranasal formulation without oxytocin
Outcomes
Primary Outcome Measures
Mean change of migraine days
Baseline is the 28-day screening period before study drug administration
Secondary Outcome Measures
Mean change of moderate or severe headache days
Proportion of subjects experiencing a ≥50% reduction in migraine days
Mean change in days using rescue medication
Proportion of subjects experiencing a reduction in headache severity and pain score 2 hours after dosing
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01839149
Brief Title
TI-001 (Intranasal Oxytocin) for Treatment of High Frequency Episodic Migraine and Chronic Migraine
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Trigemina, Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study evaluates the use of oxytocin, given as a nasal spray, for treatment of high frequency episodic migraine and chronic migraine.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Frequency Episodic Migraine and Chronic Migraine
Keywords
Refractory Chronic Migraine, Medically Intractable Chronic Migraine, Oxytocin, Intranasal oxytocin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TI-001 (intranasal oxytocin)
Arm Type
Experimental
Arm Description
TI-001 is intranasal oxytocin
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo for TI-001 is the same intranasal formulation without oxytocin
Intervention Type
Drug
Intervention Name(s)
TI-001
Other Intervention Name(s)
Intranasal oxytocin
Intervention Description
TI-001 is intranasal oxytocin
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Mean change of migraine days
Description
Baseline is the 28-day screening period before study drug administration
Time Frame
Baseline and 28 days of treatment
Secondary Outcome Measure Information:
Title
Mean change of moderate or severe headache days
Time Frame
Baseline and 28 days of treatment
Title
Proportion of subjects experiencing a ≥50% reduction in migraine days
Time Frame
Baseline and 28 days of treatment
Title
Mean change in days using rescue medication
Time Frame
Baseline and 28 days of treatment
Title
Proportion of subjects experiencing a reduction in headache severity and pain score 2 hours after dosing
Time Frame
Baseline and 28 days of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1. Men and women, aged 18 to 65 years with primary diagnosis of high frequency episodic migraine or chronic migraine.
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raquel Izumi, PhD
Organizational Affiliation
Trigemina, Inc
Official's Role
Study Director
Facility Information:
City
Fitzroy
Country
Australia
City
Prahran
Country
Australia
City
Sherwood
Country
Australia
City
Santiago
Country
Chile
City
Tauranga
Country
New Zealand
City
Wellington
Country
New Zealand
12. IPD Sharing Statement
Learn more about this trial
TI-001 (Intranasal Oxytocin) for Treatment of High Frequency Episodic Migraine and Chronic Migraine
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