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 range18 Years

SexALL

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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.
✕. Past or current history of any condition that may hinder study procedures or confuse interpretation of data.
✕. Nasal obstruction of any cause as determined at screening.

What they're measuring

Reduction in Headache Intensity

Timeframe: 2 hours after administration of study medication

Trial details

NCT IDNCT00963040

SponsorMedVadis Research Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-08

Results submitted2023-04-14

View on ClinicalTrials.gov More Chronic Daily Headache trials