Trial | NCT01839149  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    oxytocin ...

  • Study Participants

    240
This study evaluates the use of oxytocin, given as a nasal spray, for treatment of high frequency episodic migraine and chronic migraine.
Study Started
May 31
2013
Primary Completion
Oct 31
2015
Study Completion
Jan 31
2016
Last Update
May 13
2016
Estimate

Drug TI-001

TI-001 is intranasal oxytocin

  • Other names: Intranasal oxytocin

Drug Placebo

TI-001 (intranasal oxytocin) Experimental

TI-001 is intranasal oxytocin

Placebo Placebo Comparator

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

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:

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
No Results Posted