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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Trigemina, Inc
ClinicalTrials.gov Identifier:
NCT01839149
First received: April 17, 2013
Last updated: May 11, 2016
Last verified: May 2016
  Purpose
This study evaluates the use of oxytocin, given as a nasal spray, for treatment of high frequency episodic migraine and chronic migraine.

Condition Intervention Phase
High Frequency Episodic Migraine and 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 ]

Enrollment: 240
Study Start Date: May 2013
Study Completion Date: January 2016
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
Drug: TI-001
TI-001 is intranasal oxytocin
Other Name: Intranasal oxytocin
Placebo Comparator: Placebo
Placebo for TI-001 is the same intranasal formulation without oxytocin
Drug: Placebo

  Eligibility

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

  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

Locations
Australia
Fitzroy, Australia
Prahran, Australia
Sherwood, Australia
Chile
Santiago, Chile
New Zealand
Tauranga, New Zealand
Wellington, New Zealand
Sponsors and Collaborators
Trigemina, Inc
Investigators
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: May 11, 2016
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
Oxytocin
Intranasal oxytocin

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 28, 2016