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

High Frequency Episodic Migraine and Chronic Migraine research study

What is the primary objective of this study?

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

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

High Frequency Episodic Migraine and Chronic Migraine

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:TI-001TI-001 is intranasal oxytocin

Drug:Placebo

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

TI-001 (intranasal oxytocin)TI-001 is intranasal oxytocin

PlaceboPlacebo for TI-001 is the same intranasal formulation without oxytocin

Study Status

Completed

Start Date: May 2013

Completed Date: January 2016

Phase: Phase 2

Type: Interventional

Design:

Primary Outcome: Mean change of migraine days

Secondary Outcome: Mean change of moderate or severe headache days

Study sponsors, principal investigator, and references

Principal Investigator: Raquel Izumi, PhD

Lead Sponsor: Trigemina, Inc

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01839149

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