Health Innovation Research

NEW STUDY ANNOUNCEMENT

Migraine Study

DO YOU SUFFER FROM REGULAR MIGRAINES?

If so, you could help test a new product in a medical study to investigate migraine pain treatment.

Check your eligibility here

If you experience 1 or more migraines every 2 months, you could help with this research.

Thank you for your interest in RDC Clinical’s study into the effectiveness of PEA, a product previously researched for its anti-inflammatory and pain-relieving properties. To help with this study, we’re looking for males and females 18 years and older who currently experience 1 or more migraines every 2 months.

Simply record up to 4 migraines within the 4-month study period. 

So that we can scientifically measure the product’s effectiveness, you would be required to record your migraine pain and take the study product up to 4 times within a 4-month period.

If you’d like to take part in this study, we’d love to hear from you. More information is below, click here for the  eligibility & registration form.

About the product you’ll help assess...

The product is PEA, which is a fatty acid that occurs naturally in the body. It has been widely studied for its anti-inflammatory and pain-relieving properties.

PEA is approved for use by the TGA (Therapeutic Goods Administration) for pain relief.

The aim of this study is to assess the effectiveness of PEA compared to a placebo for reducing the pain severity and duration of migraines. As this study compares the two products, you will have an equal (50%) chance of being allocated either PEA or placebo.

About the study you’ll take part in…migraine monitoring.

This study can be completed remotely as all requirements can be completed over the phone and online. There is no requirement for you to visit our clinic site.

Once enrolled in the trial, you will be sent your study product in capsule form.

The maximum study duration for each participant is 4 months. During that time, you will be able to record data for up to 4 migraine episodes. You will record each migraine for a maximum of 8 hours, after 4 hours you may revert to your normal pain medication if required.

Once you start a migraine episode, you will be sent timed text messages prompting you to record your current pain level.

If you’re a migraine sufferer and would like to take part, please register your interest by answering the questionnaire and completing the form on this page… we’ll then get in touch to screen you for suitability.

Migraine Episode Time Points

At the time of onset of your migraine…

  • At first sign of migraine, take 4 capsules of the study product
  • Score your migraine pain severity every 30 minutes until pain subsides up to a maximum of 4 hours (a smartphone, tablet or computer access is required)

Should you still have pain 4 hours after the initial migraine onset…

  • You may take your regular pain medication
  • Score your migraine pain every hour for up to a further 4 hours

The following day (approx 12-24 hours after migraine onset)

Complete a short follow up questionnaire regarding your migraine and study product.

Check if you can take part… study participant requirements.

Are you…

  • A male or female aged 18 years and older?
  • Currently experiencing 1 or more migraines every 2 months?
  • A non-smoker?
  • Generally healthy?
Ethics approval & privacy… you’ll be in safe, professional hands.

This RDC Clinical study has been approved by the Bellberry Human Research Ethics Committee under Approval Number: 2020-01-029. The study is also registered on the Australian and New Zealand Clinical Trial Registry under Registration Number:  ACTRN12620000598987.

Trained Trial Co-ordinators will supervise your progress throughout the study. Any of your personal information collected during the study will be kept in the strictest confidence and no identifying information is ever published.

You can complete the study at home, there are no in-clinic visits required.

This study requires that you log your migraine pain severity during your migraine. As such, there is no requirement for in-clinic visits. During each migraine episode you will receive a series of timed text messages with a link to complete a short online form.