Trial record 13 of 926 for:
Headache
Effect of Intranasal Oxytocin on Headache in Chronic Daily Headache
This study has been completed.
Sponsor:
MedVadis Research Corporation
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
- 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.
Contacts and Locations
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 May 23, 2013