Effect of Intranasal Oxytocin on Headache in Chronic Daily Headache

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MedVadis Research Corporation
ClinicalTrials.gov Identifier:
NCT00963040
First received: August 18, 2009
Last updated: September 8, 2011
Last verified: September 2011
  Purpose

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. 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.


Condition Intervention
Chronic Daily Headache
Drug: Syntocinon (Oxytocin)
Drug: Sterile water

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Intranasal Oxytocin on Headache Intensity and Headache-associated Symptoms in Patients Suffering From Chronic Daily Headache

Resource links provided by NLM:


Further study details as provided by MedVadis Research Corporation:

Primary Outcome Measures:
  • Reduction in headache intensity [ Time Frame: 2 hours post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduction in nausea, vomiting, photophobia, and phonophobia [ Time Frame: 2 hours post-treatment ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: November 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Syntocinon® Drug: Syntocinon (Oxytocin)
4 actuations in each nostril for a total dose of 32 IU
Placebo Comparator: Sterile water Drug: Sterile water
4 actuations in each nostril

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Headache on equal to or more than 15 days per month for at least 6 months; the headaches can be migraine or tension.
  2. 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.
  3. Headaches typically last for at least 4 hours.
  4. Subjects are on a stable headache treatment, if any, for at least 2 months.

Exclusion Criteria:

  1. Headache symptoms assessed to be predominately occipital.
  2. Allergy to oxytocin.
  3. History of addictive behavior (e.g. alcoholism, drug abuse).
  4. History of significant psychiatric disorder.
  5. History of clinically-significant, functionally-impairing cardiovascular or pulmonary disease.
  6. Upper-respiratory tract infection at the time of randomization.
  7. Past or current history of any condition that may hinder study procedures or confuse interpretation of data.
  8. Nasal obstruction of any cause as determined at screening.
  9. Major surgery or trauma within 4 weeks of screening.
  10. Women who are pregnant as evidenced by a serum HCG, nursing, or trying to conceive.
  11. Use of intranasally administered medications, for example, vasoconstrictors or corticosteroids, within 2 weeks of randomization.
  12. Use of an investigational medication or device within 30 days of randomization.
  13. Unable or unwilling to adhere to the study-specific procedures and restrictions.
  14. Any condition that in the opinion of the investigator would compromise the safety of the subject or the quality of the data.
  15. Alanine aminotransaminase (ALT) or aspartate aminotransaminase (AST) equal or greater than 3 times the upper limit of normal (ULN).
  16. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00963040

Locations
United States, Massachusetts
MedVadis Research Corporation
Wellesley Hills, Massachusetts, United States, 02481
Sponsors and Collaborators
MedVadis Research Corporation
Investigators
Principal Investigator: Egilius LH Spierings, MD, PhD Harvard Medical School
  More Information

No publications provided

Responsible Party: MedVadis Research Corporation
ClinicalTrials.gov Identifier: NCT00963040     History of Changes
Other Study ID Numbers: TI-004
Study First Received: August 18, 2009
Last Updated: September 8, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by MedVadis Research Corporation:
intranasal oxytocin
acute headache treatment
chronic daily headache

Additional relevant MeSH terms:
Headache
Headache Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014