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

Phase 2

• Conditions: migraine headache; Neurological - Other neurological disorders

• Registration Number: ACTRN12607000384459
• Lead Sponsor: Trigemina, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-07-23
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in headache intensity (5 Point Pain Intensity Scale)[2 hours after study drug administration]

Secondary Outcome Measures

Name	Time	Method
Reduction in headache intensity (5-Point Pain Intensity Scale) [At 0.5, 4 and 24 hours after study drug administration];Reduction in the following clinical signs and symptoms that may be associated with migraine [At 0.5, 2, 4 and 24 hours after study drug administration];Frequency/use of rescue medication [At 2, 4 and 24 hours after study drug administration.];Overall treatment satisfaction [24 hours after study drug administration.];Duration of pain relief [After study drug administration.]