To evaluate the efficacy of nasal oxytocin in the treatment of migraine headaches

A Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate Nasal Oxytocin for the Treatment of Migraine Headaches

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000384459

Enrollment

100

Registered

2007-07-23

Start date

2007-09-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Nasal oxytocin may be useful in preventing migraine attacks. The purpose of this study is to determine how well nasal oxytocin helps treat migraine attacks and the safety of nasal oxytocin and any side effects that may happen when it is given to migraine patients

Interventions

active drug: nasal oxytocin administered as one puff (100µL, 4IU) in each nostril at time 0, 5 minutes, 10 minutes and 15 minutes on Study Day 1

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

Diagnosed with migraine according to IHS-criteria (see Appendix 1)Suffering from migraine > 1 yearAt least 1-6 attacks per month in each of the six months prior to the start of this study Typical migraines of at least moderate intensity (based on a 5 point scale) if left untreatedAbility to reliably identify the onset of a migraine attackStarted suffering from migraine before age 50 years Female subjects of child-bearing potential who are fewer than 2 years post-menopausal, must agree to, and comply with, using highly effective methods of birth control (i.e. condom plus spermicide, combined oral contraceptive, implant, injectable, indwelling intrauterine device, sexual abstinence, or a vasectomized partner) while participating in this study.Written informed consent, willingness, and ability to comply with all study procedures

Exclusion criteria

Currently taking another investigational drug.Allergic to certain additives in the nasal oxytocin medication.Have other medical conditions that may interfere with participation in this study.Female and are pregnant or are nursing and will not agree to stop nursing.

Outcome results