TI-001 (Intranasal Oxytocin) for Treatment of Chronic Migraine

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Trigemina, Inc
ClinicalTrials.gov Identifier:
First received: April 17, 2013
Last updated: October 27, 2015
Last verified: October 2015
This study evaluates the use of oxytocin, given as a nasal spray, for treatment of chronic migraine.

Condition Intervention Phase
Chronic Migraine
Drug: TI-001
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Trigemina, Inc:

Primary Outcome Measures:
  • Mean change of migraine days [ Time Frame: Baseline and 28 days of treatment ] [ Designated as safety issue: No ]
    Baseline is the 28-day screening period before study drug administration

Secondary Outcome Measures:
  • Mean change of moderate or severe headache days [ Time Frame: Baseline and 28 days of treatment ] [ Designated as safety issue: No ]
  • Proportion of subjects experiencing a >=50% reduction in migraine days [ Time Frame: Baseline and 28 days of treatment ] [ Designated as safety issue: No ]
  • Mean change in days using rescue medication [ Time Frame: Baseline and 28 days of treatment ] [ Designated as safety issue: No ]
  • Proportion of subjects experiencing a reduction in headache severity and pain score 2 hours after dosing [ Time Frame: Baseline and 28 days of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: May 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TI-001 (intranasal oxytocin)
TI-001 is intranasal oxytocin administered at 15 to 60 IU per dose.
Drug: TI-001
TI-001 is intranasal oxytocin administered at 15 to 60 IU per dose.
Other Name: Intranasal oxytocin
Placebo Comparator: Placebo
Placebo for TI-001 is the same intranasal formulation without oxytocin.
Drug: Placebo


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Men and women, aged 18 to 65 years
  2. Primary diagnosis of chronic migraine based on the International Headache Society definition as defined below:

    1. Migraine headache without aura occurring on ≥15 days per month for > 3 months and fulfilling criteria b-d below:
    2. Headache has ≥ 2 of the following criteria:

    i. Unilateral location ii. Pulsating quality iii. Severe pain intensity iv. Aggravation by or causing avoidance of routine physical activity c. During headache ≥ 1 of the following: i. Nausea and/or vomiting ii. Photophobia and phonophobia d. Not attributed to another disorder

  3. Currently experiencing migraine headaches of at least 4 hours in duration, which are severe in pain intensity while on standard of care (eg, triptans and ergotamines)

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01839149

Fitzroy, Australia
Prahran, Australia
Sherwood, Australia
Santiago, Chile
New Zealand
Tauranga, New Zealand
Wellington, New Zealand
Sponsors and Collaborators
Trigemina, Inc
Study Director: Raquel Izumi, PhD Trigemina, Inc
  More Information

Responsible Party: Trigemina, Inc
ClinicalTrials.gov Identifier: NCT01839149     History of Changes
Other Study ID Numbers: TRIG-05 
Study First Received: April 17, 2013
Last Updated: October 27, 2015
Health Authority: Chile: Institute of Public Health (Instituto de Salud Pública de Chile)

Keywords provided by Trigemina, Inc:
Refractory Chronic Migraine
Medically Intractable Chronic Migraine
Intranasal oxytocin

Additional relevant MeSH terms:
Migraine Disorders
Brain Diseases
Central Nervous System Diseases
Headache Disorders
Headache Disorders, Primary
Nervous System Diseases
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 04, 2016