Trial · Interventional

CompletedNot applicableResults postedRegistry data

Effect of Intranasal Oxytocin on Headache in Chronic Daily Headache

NCTNCT00963040Other idTI-004, TI-005

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Overview

Status: Completed
Phase: Not applicable
Enrollment: 60 participants (actual)
Sponsor: MedVadis Research Corporation · Industry
Design: Randomized · Double masking
Countries: 1 country
United States
Start: Nov 2009
Primary completion: Aug 2010
Completion: Aug 2010
First posted: 20 Aug 2009 (estimated)
Last update posted: 15 Jun 2023
Conditions: Chronic Daily Headache

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

200920102011

N/A
Effect of Intranasal Oxytocin on Headache in Chronic Daily Headache
NCT00963040
Nov 2009 to Aug 2010

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

SyntocinonDrug
Sterile waterDrug
SyntocinonDrug
Sterile waterDrug

Arms4

Experimental
Syntocinon® TI-004 protocol
Treated group
Placebo comparator
Sterile water TI-004 protocol
Placebo group
Experimental
Syntocinon® TI-005 protocol
Placebo comparator
Sterile water TI-005 protocol

Primary outcomes1

Outcomes the sponsor listed as primary.

Reduction in Headache Intensity
Time frame · 2 hours after administration of study medication
Registry description
Number (Percentage) of participants with headache improvement defined as a reduction from moderate or severe to mild or absent (4-point categorical scale)

Secondary outcomes(5)

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
Registry description
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
Time frame · ½, 1, 2, 3 (TI005 study only), 4, 8 (TI005 study only), and 24 hours after administration of study medication
Registry description
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
Time frame · ½, 1, 2, 3 (TI005 study only), 4, 8 (TI005 study only), and 24 hours after administration of study medication
Registry description
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
Time frame · Up to 24 hours after intervention administration
Registry description
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
Time frame · Up to 24 hours after intervention administration
Registry 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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· 2 hours after administration of study medication

Reduction in Headache Intensity

Group	Value (Participants)
Syntocinon® (Oxytocin) TI-004 Protocol	6
Placebo TI-004 Protocol	4
Syntocinon® (Oxytocin) TI-005 Protocol	1
Placebo TI-005 Protocol	3

Secondary and other outcome results(5)

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

Reduction in Headache Intensity

Group	Value (Participants)
Syntocinon® (Oxytocin) TI-004 Protocol	0
Placebo TI-004 Protocol	1
Syntocinon® (Oxytocin) TI-005 Protocol	0
Placebo TI-005 Protocol	0

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

Average Headache Intensity

Group	Value (score on a scale)	Spread
Syntocinon® (Oxytocin) TI-004 Protocol	7.1	1.5
Placebo TI-004 Protocol	7.1	1.6
Syntocinon® (Oxytocin) TI-005 Protocol	6.5	0.8
Placebo TI-005 Protocol	6.1	1.2

Secondary outcomeCount of participants· 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

Group	Value (Participants)
Syntocinon® (Oxytocin) TI-004 Protocol	7
Placebo TI-004 Protocol	2
Syntocinon® (Oxytocin) TI-005 Protocol	0
Placebo TI-005 Protocol	1

Secondary outcomeCount of participants· Up to 24 hours after intervention administration

Intake of Rescue Medication

Group	Value (Participants)
Syntocinon® (Oxytocin) TI-004 Protocol	12
Placebo TI-004 Protocol	10
Syntocinon® (Oxytocin) TI-005 Protocol	4
Placebo TI-005 Protocol	2

Secondary outcomeCount of participants· Up to 24 hours after intervention administration

Participant Satisfaction

Group	Value (Participants)
Syntocinon® (Oxytocin) TI-004 Protocol	4
Placebo TI-004 Protocol	5
Syntocinon® (Oxytocin) TI-005 Protocol	4
Placebo TI-005 Protocol	2

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Syntocinon® (Oxytocin) TI-004 ProtocolSelf-administered by participants in the upright sitting position with the neck flexed. The pump was primed and one nostril was closed with the finger. The tip of the bottle was inserted into the other nostril at an angle of 60 degrees. One actuation (4 IU) was administered while gently sniffing through that nostril. The tip of the bottle was then inserted into the other nostril for administration of another 4 IU. This procedure was repeated three times with 5-minute intervals (allowing for medication uptake and clearance) for a total dose of 32 IU followed by in-clinic observation for 2 hours post-dose in the TI004 study.	0 / 22	0 / 22	8 / 22
Sterile Water TI-004 ProtocolAdministration of placebo similar to oxytocin arm: 4 actuations in each nostril of sterile water with in-clinic observation for 2 hours post-dose in the TI004 study	0 / 18	0 / 18	3 / 18
Syntocinon® (Oxytocin) TI-005 ProtocolSelf-administered by participants in the upright sitting position with the neck flexed. The pump was primed and one nostril was closed with the finger. The tip of the bottle was inserted into the other nostril at an angle of 60 degrees. One actuation (4 IU) was administered while gently sniffing through that nostril. The tip of the bottle was then inserted into the other nostril for administration of another 4 IU. This procedure was repeated seven times with 5-minute intervals (allowing for medication uptake and clearance) for a total dose of 64 IU followed by 4 hours post-dose in-clinic observation in the TI005 study.	0 / 12	0 / 12	2 / 12
Sterile Water TI-005 ProtocolAdministration of placebo similar to oxytocin arm: 7 actuations of sterile with 5-minute intervals followed by 4 hours post-dose of in-clinic observation in the TI005 study.	0 / 8	0 / 8	1 / 8

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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.

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