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

High Frequency Episodic Migraine and Chronic Migraine Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01839149
• Other study ID #: TRIG-05
• Status: Completed
• Phase: Phase 2
• First received: April 17, 2013
• Last updated: May 11, 2016
• Start date: May 2013
• Est. completion date: January 2016

Study information

• Verified date: May 2016
• Source: Trigemina, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: Institute of Public Health (Instituto de Salud Pública de Chile)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: January 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• High Frequency Episodic Migraine and Chronic Migraine
• Migraine Disorders

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Trigemina, Inc

Countries where clinical trial is conducted

Australia,  Chile,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change of migraine days	Baseline is the 28-day screening period before study drug administration	Baseline and 28 days of treatment	No
Secondary	Mean change of moderate or severe headache days		Baseline and 28 days of treatment	No
Secondary	Proportion of subjects experiencing a =50% reduction in migraine days		Baseline and 28 days of treatment	No
Secondary	Mean change in days using rescue medication		Baseline and 28 days of treatment	No
Secondary	Proportion of subjects experiencing a reduction in headache severity and pain score 2 hours after dosing		Baseline and 28 days of treatment	No