Status:
COMPLETED
Effect of Intranasal Oxytocin on Headache in Chronic Daily Headache
Lead Sponsor:
MedVadis Research Corporation
Conditions:
Chronic Daily Headache
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Detailed Description
The TI004 and TI005 studies both used a randomized, double-blind, placebo-controlled, parallel-group study design. A protocol-specified interim analysis was performed after completion of the first 40 ...
Eligibility Criteria
Inclusion
- 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
- 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.
- Major surgery or trauma within 4 weeks of screening.
- Women who are pregnant as evidenced by a serum HCG, nursing, or trying to conceive.
- Use of intranasally administered medications, for example, vasoconstrictors or corticosteroids, within 2 weeks of randomization.
- Use of an investigational medication or device within 30 days of randomization.
- Unable or unwilling to adhere to the study-specific procedures and restrictions.
- Any condition that in the opinion of the investigator would compromise the safety of the subject or the quality of the data.
- Alanine aminotransaminase (ALT) or aspartate aminotransaminase (AST) equal or greater than 3 times the upper limit of normal (ULN).
- Serum creatinine of equal or greater than 1.8 mg/dL. Resting, sitting systolic blood pressure equal or greater than 160 mmHg or diastolic blood pressure equal or greater than 100 mmHg at screening. For patients with previously diagnosed hypertension, antihypertensive medications must be stable for at least 30 days prior to screening.
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00963040
Start Date
November 1 2009
End Date
August 1 2010
Last Update
June 15 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
MedVadis Research Corporation
Wellesley Hills, Massachusetts, United States, 02481