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Completed

NCT Number: NCT01839149

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

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

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Key information

Conditions

High Frequency Episodic Migraine and Chronic Migraine

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fitzroy, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Treatment and study plan

TI-001

Drug

TI-001 is intranasal oxytocin

Other names: Intranasal oxytocin

Placebo

Drug

Primary outcomes

  1. Mean change of migraine days

    Time frame: Baseline and 28 days of treatment

    Baseline is the 28-day screening period before study drug administration

Secondary outcomes

  1. Mean change of moderate or severe headache days

    Time frame: Baseline and 28 days of treatment

  2. Proportion of subjects experiencing a ≥50% reduction in migraine days

    Time frame: Baseline and 28 days of treatment

  3. Mean change in days using rescue medication

    Time frame: Baseline and 28 days of treatment

  4. Proportion of subjects experiencing a reduction in headache severity and pain score 2 hours after dosing

    Time frame: Baseline and 28 days of treatment

Sponsors and collaborators

Lead sponsor

Trigemina, Inc

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Apr 24, 2013
Registry last updated
May 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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