Back to resultsEffect of Intranasal Oxytocin on Headache in Chronic Daily Headache
Primary Purpose
Chronic Daily Headache
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Syntocinon
Sterile water
Syntocinon
Sterile water
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Daily Headache focused on measuring intranasal oxytocin, acute headache treatment, chronic daily headache
Eligibility Criteria
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.
Sites / Locations
- MedVadis Research Corporation
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
Syntocinon® TI-004 protocol
Sterile water TI-004 protocol
Syntocinon® TI-005 protocol
Sterile water TI-005 protocol
Arm Description
Treated group
Placebo group
Outcomes
Primary Outcome Measures
Reduction in Headache Intensity
Number (Percentage) of participants with headache improvement defined as a reduction from moderate or severe to mild or absent (4-point categorical scale)
Secondary Outcome Measures
Reduction in Headache Intensity
Number (Percentage) of participants with headache improvement defined as a reduction from moderate or severe to mild or absent (4-point categorical scale)
Average Headache Intensity
Average headache intensity as rated on the 11-point numerical rating scale (0 = no pain; 10 = worst pain possible).
Presence of Nausea, Vomiting, Photophobia, and Phonophobia
Number (percentage) of participants with effects of oxytocin on symptoms associated with chronic daily headache, such as nausea, vomiting, photophobia, and phonophobia
Intake of Rescue Medication
Number of participants who took rescue medication (examples: ibuprofen, Tylenol, zolmitriptan) for headache at any time within the 24 hours after intervention administration.
Participant Satisfaction
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.
Full Information
NCT ID
NCT00963040
First Posted
August 18, 2009
Last Updated
June 13, 2023
Sponsor
MedVadis Research Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00963040
Brief Title
Effect of Intranasal Oxytocin on Headache in Chronic Daily Headache
Official Title
The Effect of Intranasal Oxytocin on Headache Intensity and Headache-associated Symptoms in Patients Suffering From Chronic Daily Headache
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MedVadis Research Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 headache.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Daily Headache
Keywords
intranasal oxytocin, acute headache treatment, chronic daily headache
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Syntocinon® TI-004 protocol
Arm Type
Experimental
Arm Description
Treated group
Arm Title
Sterile water TI-004 protocol
Arm Type
Placebo Comparator
Arm Description
Placebo group
Arm Title
Syntocinon® TI-005 protocol
Arm Type
Experimental
Arm Title
Sterile water TI-005 protocol
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Syntocinon
Other Intervention Name(s)
Oxytocin
Intervention Description
4 actuations in each nostril for a total dose of 32 IU
Intervention Type
Drug
Intervention Name(s)
Sterile water
Other Intervention Name(s)
Placebo
Intervention Description
4 actuations in each nostril
Intervention Type
Drug
Intervention Name(s)
Syntocinon
Other Intervention Name(s)
Oxytocin
Intervention Description
8 actuations in each nostril for a total dose of 64 IU
Intervention Type
Drug
Intervention Name(s)
Sterile water
Other Intervention Name(s)
Placebo
Intervention Description
8 actuations in each nostril
Primary Outcome Measure Information:
Title
Reduction in Headache Intensity
Description
Number (Percentage) of participants with headache improvement defined as a reduction from moderate or severe to mild or absent (4-point categorical scale)
Time Frame
2 hours after administration of study medication
Secondary Outcome Measure Information:
Title
Reduction in Headache Intensity
Description
Number (Percentage) of participants with headache improvement defined as a reduction from moderate or severe to mild or absent (4-point categorical scale)
Time Frame
½, 1, 3 (TI005 study only), 4, 8 (TI005 study only), and 24 hours after administration of study medication
Title
Average Headache Intensity
Description
Average headache intensity as rated on the 11-point numerical rating scale (0 = no pain; 10 = worst pain possible).
Time Frame
½, 1, 2, 3 (TI005 study only), 4, 8 (TI005 study only), and 24 hours after administration of study medication
Title
Presence of Nausea, Vomiting, Photophobia, and Phonophobia
Description
Number (percentage) of participants with effects of oxytocin on symptoms associated with chronic daily headache, such as 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
Title
Intake of Rescue Medication
Description
Number of participants who took rescue medication (examples: ibuprofen, Tylenol, zolmitriptan) for headache at any time within the 24 hours after intervention administration.
Time Frame
Up to 24 hours after intervention administration
Title
Participant Satisfaction
Description
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.
Time Frame
Up to 24 hours after intervention administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Egilius LH Spierings, MD, PhD
Organizational Affiliation
Harvard Medical School (HMS and HSDM)
Official's Role
Principal Investigator
Facility Information:
Facility Name
MedVadis Research Corporation
City
Wellesley Hills
State/Province
Massachusetts
ZIP/Postal Code
02481
Country
United States
12. IPD Sharing Statement
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Effect of Intranasal Oxytocin on Headache in Chronic Daily Headache
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