A Study to Evaluate the Efficacy and Safety of TNX-1900 in Patients With Chronic Migraine

What Was Tested

The trial (phase 2) is built around Oxytocin for migraine.

It had three arms (groups): one (experimental), one (experimental) and Placebo (placebo comparator).

Placebo taken intranasally twice daily.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 88 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Men and women aged 18 to 65 years, inclusive, at the time of Visit 1.

The full record lists 3 inclusion and 7 exclusion criteria; among the exclusions: history of cluster headache; presence of headaches more than 26 days a month on average for the 6 months prior to screening; use of opiates or barbiturates more than 4 days per month for more than 3 consecutive months prior to visit 1 and during the study.

How the Study Was Run

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

Because people in this Oxytocin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Oxytocin group and the comparison group ran side by side rather than switching.

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

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2022-12-06 with completion listed for 2023-10-08.

It ran at 26 sites in United States (26).

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Mean Change in the Number of Monthly Migraine Headache Days (time frame: Last 28 days before Visit 2 (Day 1) and last 28 days before Visit 5 (Week 12)).

It also tracked 6 secondary outcomes, for example Mean Change in the Number of Days Using Rescue Medication, Patient Global Impression of Change (PGIC), Mean Change in the Number of Moderate or Severe Headache Days, Mean Change in the Number of Migraine Headache Days and Mean Change From Baseline in the Migraine-Specific Quality of Life Questionnaire.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 88 people with migraine.

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

More context: the Oxytocin compound page, Migraine research.