Effect of Intranasal Oxytocin on Headache in Chronic Daily Headache (NCT00963040) | Clinical Trial Compass
CompletedNot Applicable
Effect of Intranasal Oxytocin on Headache in Chronic Daily Headache
United States60 participantsStarted 2009-11
Plain-language summary
The objective of this prospective, randomized, double-blind, parallel-group, placebo-controlled study is to determine the effectiveness of intranasal oxytocin in subjects suffering from chronic daily headache.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Headache on equal to or more than 15 days per month for at least 6 months; the headaches can be migraine or tension.
. More than half of the monthly headaches are of moderate or severe intensity on the 4-point categorical pain rating scale and are assessed as 6 or higher on the 11-point numerical pain rating scale.
. Headaches typically last for at least 4 hours.
. Subjects are on a stable headache treatment, if any, for at least 2 months.
Exclusion criteria
. Headache symptoms assessed to be predominately occipital.
. Allergy to oxytocin.
. History of addictive behavior (e.g. alcoholism, drug abuse).
. History of significant psychiatric disorder.
. History of clinically-significant, functionally-impairing cardiovascular or pulmonary disease.
. Upper-respiratory tract infection at the time of randomization.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Reduction in Headache Intensity
Timeframe: 2 hours after administration of study medication