TI-001 (Intranasal Oxytocin) for Treatment of High Freque... | NCT01839149

Studies
TI-001 (Intranasal Oxytocin) for Treatment of High Frequency Episodic Migraine and Chronic Migraine

NCT01839149

Sponsor

Trigemina, Inc

Status

Completed

Last Update Posted

May 13, 2016Estimated

Enrollment

240Actual

Phase

Phase 2

Conditions

High Frequency Episodic Migraine and Chronic Migraine

Interventions

TI-001
Placebo

Countries

Australia
Chile
New Zealand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2013

Primary Completion Date

Oct 2015Actual

Completion Date

Jan 2016Actual

First Submitted Date

Apr 17, 2013

First Submission Date that Met QC Criteria

Apr 19, 2013

First Posted Date

Apr 24, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 11, 2016

Last Update Posted Date

May 13, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study evaluates the use of oxytocin, given as a nasal spray, for treatment of high frequency episodic migraine and chronic migraine.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

240Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TI-001 (intranasal oxytocin)	Experimental	TI-001 is intranasal oxytocin	Drug: TI-001
Placebo	Placebo Comparator	Placebo for TI-001 is the same intranasal formulation without oxytocin	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TI-001	Drug	TI-001 is intranasal oxytocin	TI-001 (intranasal oxytocin)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean change of migraine days	Baseline is the 28-day screening period before study drug administration	Baseline and 28 days of treatment

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Fitzroy			Australia