Effect of Intranasal Oxytocin on Headache in Chronic Daily Headache

NCT00963040 | Completed Results

• 1 other identifier: TI-004, TI-005
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Daily Headache

Keywords

intranasal oxytocin; acute headache treatment; chronic daily headache

Outcome Measures

Primary Outcomes (1)

• 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)

  2 hours after administration of study medication

Secondary Outcomes (5)

• Reduction in Headache Intensity

  ½, 1, 3 (TI005 study only), 4, 8 (TI005 study only), and 24 hours after administration of study medication

• Average Headache Intensity

  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

  ½, 1, 2, 3 (TI005 study only), 4, 8 (TI005 study only), and 24 hours after administration of study medication

• Intake of Rescue Medication

  Up to 24 hours after intervention administration

• Participant Satisfaction

  Up to 24 hours after intervention administration

Study Arms (4)

Syntocinon® TI-004 protocol

EXPERIMENTAL

Treated group

Drug: Syntocinon

Sterile water TI-004 protocol

PLACEBO COMPARATOR

Placebo group

Drug: Sterile water

Syntocinon® TI-005 protocol

EXPERIMENTAL

Drug: Syntocinon

Sterile water TI-005 protocol

PLACEBO COMPARATOR

Drug: Sterile water

Interventions

Syntocinon DRUG

4 actuations in each nostril for a total dose of 32 IU

Also known as: Oxytocin

Syntocinon® TI-004 protocol

Sterile water DRUG

4 actuations in each nostril

Also known as: Placebo

Sterile water TI-004 protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• MedVadis Research Corporation: lead

Study Sites (1)

MedVadis Research Corporation

Wellesley Hills, Massachusetts, 02481, United States

Location

MeSH Terms

Conditions

Headache Disorders

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Egilius L.H. Spierings, M.D., Ph.D.
• Organization: MedVadis Research Corporation

Spierings@MedVadis.com

781-588-5430

Study Officials

• Egilius LH Spierings, MD, PhD

  Harvard Medical School (HMS and HSDM)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2009
• First Posted: August 20, 2009
• Study Start: November 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: June 15, 2023
• Results First Posted: June 15, 2023

Record last verified: 2023-06

Locations

US (1)