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PrevANZ Vitamin D MS PreventionTrial

 

Progress report June 2013    


Background

PrevANZ is a world-first clinical trial that will test whether oral vitamin D supplementation can prevent MS in those at risk of developing the disease.

The Phase IIb randomised, double blind, placebo-controlled trial will focus on the possibility of using oral vitamin D supplementation to prevent a diagnosis of MS following a person’s presentation with a first episode of symptoms – people with CIS or clinically isolated syndrome.

PrevANZ will also test appropriate dosage levels and safety. Vitamin D3 will be administered at doses of 0 (placebo), 1000 international units (I.U), 5000 I.U., and 10,000 I.U. daily for 48 weeks. Patients will be monitored by clinical and MRI measures to determine if oral vitamin D supplementation can delay or prevent a second clinical or radiological event that would result in a diagnosis of clinically definite MS. The trial will take four years to complete.

The need for the PrevANZ trial has arisen from a now significant body of evidence for the role that vitamin D deficiency plays in MS. However, to date there has not been a clinical trial conducted to provide the necessary evidence on the benefits that can be expected from vitamin D supplementation or the correct dose.

This is an area in which the expertise in Australia and New Zealand can contribute significantly to the prevention and better treatment of MS globally.  

Progress

Project Governance

The PrevANZ Steering Committee was established to guide the development of the trial protocol and oversee the trial throughout. The Steering Committee comprises MS neurologists, epidemiologists, an endocrinologist, statistician and radiologist. The Steering Committee have held monthly teleconferences to oversee the running of the trial, while a smaller working group have been holding fortnightly teleconferences with the contract research organisation (CRO), Neuroscience Trials Australia (NTA), to coordinate all logistical aspects to get the trial up and running.

Logistics

Trial documentation - All of the trial documentation has now been finalised including the Protocol, Procedures and Laboratory Manuals for investigators at the PrevANZ trial sites, Patient questionnaires and Patient Informed Consent Forms, and the electronic Case Report Form (eCRF).

Regulatory approvals - Ethics approvals have been obtained from the Human Research Ethics Committees of all institutions involved in the trial and most regulatory approvals have also been obtained.

Central MRI Reading Centre - The UK team have commenced their involvement in the trial by performing quality control reviews of ‘dummy’ MRI scans from each site, to ensure they meet the standards required for analysis of trial outcome measures. From now on they will continue to screen all MRI scans as patients undergo scans at baseline and at 24 and 48 weeks after commencing vitamin D supplementation.

Vitamin D capsules - Lipa Pharmaceuticals, a contract manufacturing company, has manufactured the first of the two batches of capsules that are required for the trial (Capsules have a 24 month expiry period). The capsules were delivered to the central pharmacy at the Austin Hospital, Melbourne in January 2013. All initiated sites have now received vitamin D kits for their first four patients (kits are de-identified and randomised to ensure investigators and patients remain blind to their allocated dose).

Trial sites - Initiation

21 trial sites (16 in Australia, 5 in New Zealand) have now committed to conduct the trial. These sites represent the major MS clinical trial centres in Australia and New Zealand, with highly experienced MS neurologists and triallists as the principal investigators.

As at 30 June, 2013, 15 trial sites have undergone initiation by NTA and are ready to commence enrolling patients. Four further sites will be initiated by the end of August 2013. Two additional sites will come on board in the second half of 2013 or early 2014.

Patient enrolment

The first patient has been enrolled in the trial in Perth, WA. Several more patients are already undergoing screening at several other sites around Australia and NZ. This is a very positive start to the trial with enrolments occurring so rapidly following site initiation.

With patient enrolment to occur over the next 2.5 years and patients to be in the trial (i.e. ‘on drug’ and monitored for 48 weeks), we anticipate that the last patients will complete the trial in December 2016. Data analysis will occur in early 2017 with the final trial outcome expected by June 2017.

Funding and expenditure

Contributions from Foundation 5 Million+, Trish MS Research Foundation, the John T Reid Charitable Trusts, MS Societies of WA, Tasmania and Queensland, Clayton Utz Foundation and other private donations have been received for the trial.

The total trial budget now stands at almost $2.8 million dollars. Efforts continue at MSRA to raise a further $800,000 to achieve a fully enrolled trial of 240 patients for a statistically robust and conclusive result to the trial.      

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