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

May 11, 2016 updated by: Trigemina, Inc

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Fitzroy, Australia
      • Prahran, Australia
      • Sherwood, Australia
  • Chile
      • Santiago, Chile
  • New Zealand
      • Tauranga, New Zealand
      • Wellington, New Zealand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TI-001 (intranasal oxytocin)
TI-001 is intranasal oxytocin
Drug: TI-001
TI-001 is intranasal oxytocin
Other Names:
  • Intranasal oxytocin
Placebo Comparator: Placebo
Placebo for TI-001 is the same intranasal formulation without oxytocin
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean change of moderate or severe headache days
Time Frame: Baseline and 28 days of treatment
Baseline and 28 days of treatment
Proportion of subjects experiencing a ≥50% reduction in migraine days
Time Frame: Baseline and 28 days of treatment
Baseline and 28 days of treatment
Mean change in days using rescue medication
Time Frame: Baseline and 28 days of treatment
Baseline and 28 days of treatment
Proportion of subjects experiencing a reduction in headache severity and pain score 2 hours after dosing
Time Frame: Baseline and 28 days of treatment
Baseline and 28 days of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Trigemina, Inc

Investigators

  • Study Director: Raquel Izumi, PhD, Trigemina, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

April 17, 2013

First Submitted That Met QC Criteria

April 19, 2013

First Posted (Estimate)

April 24, 2013

Study Record Updates

Last Update Posted (Estimate)

May 13, 2016

Last Update Submitted That Met QC Criteria

May 11, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRIG-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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