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
This study evaluates the use of oxytocin, given as a nasal spray, for treatment of high frequency episodic migraine and chronic migraine.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Trigemina, Inc |
Australia, Chile, New Zealand,
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 |