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

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: October 2015

Interventions

  • Drug: TI-001
    • TI-001 is intranasal oxytocin
  • Drug: Placebo

Arms, Groups and Cohorts

  • Experimental: TI-001 (intranasal oxytocin)
    • TI-001 is intranasal oxytocin
  • Placebo Comparator: Placebo
    • Placebo for TI-001 is the same intranasal formulation without oxytocin

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Mean change of moderate or severe headache days
    • Time Frame: Baseline and 28 days of treatment
  • Proportion of subjects experiencing a ≥50% reduction in migraine days
    • Time Frame: Baseline and 28 days of treatment
  • Mean change in days using rescue medication
    • Time Frame: 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Trigemina, Inc
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Raquel Izumi, PhD, Study Director, Trigemina, Inc

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