Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000384459
Ethics application status
Not yet submitted
Date submitted
20/07/2007
Date registered
23/07/2007
Date last updated
23/07/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
To evaluate the efficacy of nasal oxytocin in the treatment of migraine headaches
Scientific title
A Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate Nasal Oxytocin for the Treatment of Migraine Headaches
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
migraine headache 1966 0
Condition category
Condition code
Neurological 2064 2064 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 1898 0
Treatment: Drugs
Comparator / control treatment
control: placebo - saline nasal spray
Control group
Placebo

Outcomes
Primary outcome [1] 3147 0
Reduction in headache intensity (5 Point Pain Intensity Scale)
Timepoint [1] 3147 0
2 hours after study drug administration
Secondary outcome [1] 4882 0
Reduction in headache intensity (5-Point Pain Intensity Scale)
Timepoint [1] 4882 0
At 0.5, 4 and 24 hours after study drug administration
Secondary outcome [2] 4883 0
Reduction in the following clinical signs and symptoms that may be associated with migraine
Timepoint [2] 4883 0
At 0.5, 2, 4 and 24 hours after study drug administration
Secondary outcome [3] 4884 0
Frequency/use of rescue medication
Timepoint [3] 4884 0
At 2, 4 and 24 hours after study drug administration.
Secondary outcome [4] 4885 0
Overall treatment satisfaction
Timepoint [4] 4885 0
24 hours after study drug administration.
Secondary outcome [5] 4886 0
Duration of pain relief
Timepoint [5] 4886 0
After study drug administration.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
site personnel, subjects, investigator and Sponsor will be blinded
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2209 0
Commercial sector/Industry
Name [1] 2209 0
Trigemina, Inc.
Country [1] 2209 0
Primary sponsor type
Commercial sector/Industry
Name
Trigemina, Inc
Address
Country
Secondary sponsor category [1] 1993 0
Commercial sector/Industry
Name [1] 1993 0
Trident Clinical Research
Address [1] 1993 0
Country [1] 1993 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 4042 0
Investigator Clinic
Ethics committee address [1] 4042 0
19 Oxford Terrace, Port Lincoln 5606 South Australia
Ethics committee country [1] 4042 0
Australia
Date submitted for ethics approval [1] 4042 0
Approval date [1] 4042 0
Ethics approval number [1] 4042 0
Ethics committee name [2] 4043 0
Trialworks
Ethics committee address [2] 4043 0
Suites 4-5, Level 1, 14 Primrose Street, Sherwood Qld 4075
Ethics committee country [2] 4043 0
Australia
Date submitted for ethics approval [2] 4043 0
Approval date [2] 4043 0
Ethics approval number [2] 4043 0

Summary
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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27712 0
Address 27712 0
Country 27712 0
Phone 27712 0
Fax 27712 0
Email 27712 0
Contact person for public queries
Name 11087 0
Cathy Bradburn
Address 11087 0
Trident Clinical Reseach
Suite 204
27 Merriwa Street
GORDON NSW 2072
Country 11087 0
Australia
Phone 11087 0
02 9499 9996
Fax 11087 0
Email 11087 0
[email protected]
Contact person for scientific queries
Name 2015 0
Martin Angst
Address 2015 0
Trigemina3 Inc.
809-B Cuesta Drive #109
Mountain View CA 94040
Country 2015 0
Australia
Phone 2015 0
650 498 5109
Fax 2015 0
Email 2015 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.