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

Trigemina

Status and phase: Completed; Phase 2

Conditions: High Frequency Episodic Migraine and Chronic Migraine

Treatments: Drug: Placebo; Drug: TI-001

Study type: Interventional

Funder types: Industry

Identifiers

NCT01839149

TRIG-05

Details and patient eligibility

About

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

Enrollment: 240 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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240 participants in 2 patient groups, including a placebo group

TI-001 (intranasal oxytocin)

Experimental group

Description:

TI-001 is intranasal oxytocin

Treatment:

Drug: TI-001

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo