- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00963040
Effect of Intranasal Oxytocin on Headache in Chronic Daily Headache
The Effect of Intranasal Oxytocin on Headache Intensity and Headache-associated Symptoms in Patients Suffering From Chronic Daily Headache
Study Overview
Status
Conditions
Intervention / Treatment
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 subjects, resulting in termination of the TI004 study and development of the TI005 protocol, which included the following changes from the TI004 protocol:
- Increase in oxytocin dose from 32 to 64 IU;
- Extension of the in-clinic observation period from 2 hours post-dose to 4-hours post-dose;
- Reduction in sample size from 40 to 20 subjects;
- Elimination of the laboratory measurements during the screening visit, allowing V1 and V2 potentially to be combined, expediting study completion;
- Adding in-clinic observation and assessment at 3 hours and 4 hours post-dose and out-of-clinic assessment at 8 hours post-dose.
The primary outcome measure is the reduction in headache intensity after drug administration; secondary outcome measures are the headache symptoms, nausea, vomiting, photophobia, and phonophobia. Additional secondary outcome measures are intake of rescue medication and patient satisfaction over a period of 24 hours.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Wellesley Hills, Massachusetts, United States, 02481
- MedVadis Research Corporation
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Syntocinon® TI-004 protocol
Treated group
|
4 actuations in each nostril for a total dose of 32 IU
Other Names:
8 actuations in each nostril for a total dose of 64 IU
Other Names:
|
Placebo Comparator: Sterile water TI-004 protocol
Placebo group
|
4 actuations in each nostril
Other Names:
8 actuations in each nostril
Other Names:
|
Experimental: Syntocinon® TI-005 protocol
|
4 actuations in each nostril for a total dose of 32 IU
Other Names:
8 actuations in each nostril for a total dose of 64 IU
Other Names:
|
Placebo Comparator: Sterile water TI-005 protocol
|
4 actuations in each nostril
Other Names:
8 actuations in each nostril
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduction in Headache Intensity
Time Frame: 2 hours after administration of study medication
|
Number (Percentage) of participants with headache improvement defined as a reduction from moderate or severe to mild or absent (4-point categorical scale)
|
2 hours after administration of study medication
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduction in Headache Intensity
Time Frame: ½, 1, 3 (TI005 study only), 4, 8 (TI005 study only), and 24 hours after administration of study medication
|
Number (Percentage) of participants with headache improvement defined as a reduction from moderate or severe to mild or absent (4-point categorical scale)
|
½, 1, 3 (TI005 study only), 4, 8 (TI005 study only), and 24 hours after administration of study medication
|
Average Headache Intensity
Time Frame: ½, 1, 2, 3 (TI005 study only), 4, 8 (TI005 study only), and 24 hours after administration of study medication
|
Average headache intensity as rated on the 11-point numerical rating scale (0 = no pain; 10 = worst pain possible).
|
½, 1, 2, 3 (TI005 study only), 4, 8 (TI005 study only), and 24 hours after administration of study medication
|
Presence of Nausea, Vomiting, Photophobia, and Phonophobia
Time Frame: ½, 1, 2, 3 (TI005 study only), 4, 8 (TI005 study only), and 24 hours after administration of study medication
|
Number (percentage) of participants with effects of oxytocin on symptoms associated with chronic daily headache, such as nausea, vomiting, photophobia, and phonophobia
|
½, 1, 2, 3 (TI005 study only), 4, 8 (TI005 study only), and 24 hours after administration of study medication
|
Intake of Rescue Medication
Time Frame: Up to 24 hours after intervention administration
|
Number of participants who took rescue medication (examples: ibuprofen, Tylenol, zolmitriptan) for headache at any time within the 24 hours after intervention administration.
|
Up to 24 hours after intervention administration
|
Participant Satisfaction
Time Frame: Up to 24 hours after intervention administration
|
Participants rated their satisfaction with treatment on a 4-point scale as "Excellent", "Good", "Moderate", or "Poor".
Number (percentage) of participants who reported each rating.
|
Up to 24 hours after intervention administration
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Egilius LH Spierings, MD, PhD, Harvard Medical School (HMS and HSDM)
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TI-004, TI-005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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