Effect of Intranasal Oxytocin on Headache in Chronic Daily Headache

What Was Tested

In this not phased trial, researchers set out to test Oxytocin.

It had four arms (groups): Syntocinon® TI-004 protocol (experimental), Sterile water TI-004 protocol (placebo comparator), Syntocinon® TI-005 protocol (experimental) and Sterile water TI-005 protocol (placebo comparator).

Treated group.

Placebo group.

The registry classes the interventions as drug.

More on the Plan

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: 1.

Elimination of the laboratory measurements during the screening visit, allowing V1 and V2 potentially to be combined, expediting study completion; 5.

Additional secondary outcome measures are intake of rescue medication and patient satisfaction over a period of 24 hours.

Who Took Part

60 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

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

The full record lists 4 inclusion and 16 exclusion criteria; among the exclusions: headache symptoms assessed to be predominately occipital; allergy to oxytocin; history of addictive behavior (e.g. alcoholism, drug abuse).

How the Study Was Run

Design: randomized, parallel-group and double-blind.

The participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Oxytocin study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2009-11 with completion listed for 2010-08.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 5 secondary outcomes, for example Average Headache Intensity, Presence of Nausea, Vomiting, Photophobia, and Phonophobia, Intake of Rescue Medication and Participant Satisfaction.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 60 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Oxytocin compound page, all human trials.