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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618001951246
Ethics application status
Approved
Date submitted
14/11/2018
Date registered
3/12/2018
Date last updated
3/12/2018
Date data sharing statement initially provided
3/12/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Investigation of Blood-Based Biomarkers for the Diagnosis of Episodic and Chronic Migraine Compared with Healthy Non-Migraine Controls (The Migraine Blood Test Research Study)
Scientific title
Clinical Blood-Based Biomarkers for Migraine Diagnosis
Secondary ID [1] 296591 0
Novartis Pharmaceuticals Australia Pty Ltd #CAMG334AAU01T
Universal Trial Number (UTN)
U1111-1223-9007
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Migraine 310403 0
Condition category
Condition code
Neurological 309118 309118 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participants will complete an online questionnaire (up to approximately 20 minutes duration) about their general health and history of headaches/migraines to determine their eligibility for the study, and the experimental group to which they belong (either healthy control, episodic migraine, or chronic migraine). This may require an additional interview with the researchers (up to approximately 30 minutes duration). A single blood sample will then be obtained from each participant (up to an approximately 15 minute appointment), and the blood-based biomarkers under investigation compared between experimental groups.
Intervention code [1] 312901 0
Diagnosis / Prognosis
Comparator / control treatment
Healthy participants with no history of migraines, and only non-problematic headaches (if any). Non-problematic headaches are defined as those that do not cause the individual to miss completely or lose productivity by half at school, work, during household duties or leisure activities.
Control group
Active

Outcomes
Primary outcome [1] 308104 0
Proteomic analyses and hyperspectral imaging techniques will be used to identify potential novel blood biomarkers for the diagnosis of migraine. These biomarkers are of an exploratory nature.
Timepoint [1] 308104 0
At the time of blood sampling (baseline).
Secondary outcome [1] 353973 0
Nil
Timepoint [1] 353973 0
Nil

Eligibility
Key inclusion criteria
Healthy Participants:
1. No history of migraine.
2. Otherwise in good general health (including only non-problematic headaches (if any)).

Migraine participants:
Diagnostic criteria will be from The International Classification of Headache Disorders, 3rd Edition; The International Headache Society, Cephalagia, 2018: 38, 1-211.
1. Episodic migraine, with or without aura, where individuals experience an average of at least 2 episodes of migraine per month in the last 3 months.
2. Chronic migraine, where individuals experience an average of at least 15 days of headache per month of which at least 8 days of migraine per month for the last 3 months. Chronic migraine participants are eligible with or without concomitant medication overuse.
3. Otherwise in good general health.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Presence of an inflammatory process, or clinically significant infection in the last 4 weeks.
2. Immunisation within the last 4 weeks.
3. Clinically significant renal, hepatic, cardiac, autoimmune disease.
4. Current use of immunosuppressant medication, such as systemic corticosteroid, hydroxychloroquine, methotrexate or azathioprine.
5. Inability to read or comprehend the written information provided.
6. Current use of medications known to affect TLR responsiveness, including amitriptyline.
7. Current pregnancy.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Random sample
Timing
Both
Statistical methods / analysis
Participant sample sizes (n = 20 per group; healthy participants, episodic migraine participants, chronic migraine participants) were determined based on past clinical trial results and appropriate power calculations.

Results from the proteomic analyses and hyperspectral imaging will be entered into the statistical program, R. Machine learning and multidimensional hyperplane analysis will be undertaken to extract spectral features which are predictive of the migraine participant populations. A k-fold validation approach will be applied to the learning algorithms to allow for test and re-test reliability. Correlations will be sought between the variables and receiver operated curves to determine from which group the patient comes.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 301169 0
Commercial sector/Industry
Name [1] 301169 0
Novartis Pharmaceuticals Australia Pty Ltd
Address [1] 301169 0
54 Waterloo Road
Macquarie Park, NSW 2113
Country [1] 301169 0
Australia
Primary sponsor type
University
Name
The University of Adelaide
Address
North Terrace
Adelaide, SA 5005
Country
Australia
Secondary sponsor category [1] 300810 0
None
Name [1] 300810 0
Address [1] 300810 0
Country [1] 300810 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301913 0
The University of Adelaide Human Research Ethics Committee
Ethics committee address [1] 301913 0
The University of Adelaide
Research Services
Office of Research Ethics, Compliance and Integrity
North Terrace
Adelaide, SA 5005
Ethics committee country [1] 301913 0
Australia
Date submitted for ethics approval [1] 301913 0
21/06/2018
Approval date [1] 301913 0
24/07/2018
Ethics approval number [1] 301913 0
H-2018-149

Summary
Brief summary
There are currently no objective ways to diagnose migraine and there is no way to determine what underpins the origins of migraine in each individual. This leaves doctors and migraine sufferers without the key information that would allow for optimal treatment selection and specific diagnosis. What is needed is a simple test that can diagnose migraine patients from people without migraine and can guide treatment selection. This study will therefore explore whether some new technologies may be useful as a blood test(s) to diagnose migraine.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88538 0
Prof Paul Rolan
Address 88538 0
Level 3, Helen Mayo North
The University of Adelaide
Frome Road
Adelaide, SA 5005
Country 88538 0
Australia
Phone 88538 0
+61 8 83030599
Fax 88538 0
Email 88538 0
paul.rolan@adelaide.edu.au
Contact person for public queries
Name 88539 0
Prof Paul Rolan
Address 88539 0
Level 3, Helen Mayo North
The University of Adelaide
Frome Road
Adelaide, SA 5005
Country 88539 0
Australia
Phone 88539 0
+61 8 83130599
Fax 88539 0
Email 88539 0
paul.rolan@adelaide.edu.au
Contact person for scientific queries
Name 88540 0
Prof Mark Hutchinson
Address 88540 0
Level 3 The Braggs
The University of Adelaide
North Terrace
Adelaide, SA 5005
Country 88540 0
Australia
Phone 88540 0
+61 8 83130322
Fax 88540 0
Email 88540 0
mark.hutchinson@adelaide.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results