Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000359538
Ethics application status
Approved
Date submitted
14/08/2006
Date registered
18/08/2006
Date last updated
18/08/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
The Myer Foundation Study into Multiple Sclerosis
Scientific title
A randomized placebo controlled double blind pilot trial of unregistered drug MKTVIF75HV on brain magnetic resonance imaging indices in multiple sclerosis
Secondary ID [1] 296 0
Therapeutic Goods Association (TGA) Clinical Trial Notification (CTN): TGA CTN 2006/442
Universal Trial Number (UTN)
Trial acronym
HREC 2006.058
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsing remitting multiple sclerosis 1328 0
Condition category
Condition code
Neurological 1416 1416 0 0
Multiple sclerosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Six months of oral MKTVIF75HV (initially 18 000 IU per day). Parallel design. Magnetic resonance imaging (MRI) of the brain with triple dose gadolinium at baseline, 4, 5 and 6 months.
Intervention code [1] 1306 0
Treatment: Drugs
Comparator / control treatment
Placebo MKTVIF75HV.
Control group
Placebo

Outcomes
Primary outcome [1] 1937 0
The total number of new gadolinium enhancing lesions on MRI detected during the 6 months.
Timepoint [1] 1937 0
The timepoints for enhancing lesion detection are the MRI timepoints noted in "Intervention" above; at baseline, 4, 5 and 6 months..
Secondary outcome [1] 3397 0
The total number of new gadolinium enhancing lesions still present at end study.
Timepoint [1] 3397 0
6 month timepoint.
Secondary outcome [2] 3398 0
The number of new T2 lesions detected during the 6 months, the total cumulative volume of new gadolinium enhancing lesions, the total cumulative volume of new T2 lesions.
Timepoint [2] 3398 0
The timepoints for detection of MRI lesions are the MRI timepoints noted in "Intervention" above; at baseline, 4, 5 and 6 months.

Eligibility
Key inclusion criteria
Relapsing remitting multiple sclerosis, gadolinium enhancing lesion(s) on screening brain MRI scan with triple dose gadolinium.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Primary or secondary progressive multiple sclerosis, pregnancy, clinical relapse or systemic glucocorticoid therapy within 30 days prior to baseline scan, contraindications to closed magnet MRI scanning including claustrophobia, metal foreign body contraindications, allergy to gadolinium. Kurtzke expanded disability scale score greater than 5, past renal calculus, peanut allergy, defined biochemical abnormalities, intercurrent condition which could impair adherence to study protocol.

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)
Randomization made by statistician after participant enrollment in the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The statistician will use computer software and stratify by intercurrent specific drug therapy for multiple sclerosis.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Subjects and assessors will be blinded.
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
24/08/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1548 0
Charities/Societies/Foundations
Name [1] 1548 0
The Myer Foundation
Country [1] 1548 0
Australia
Primary sponsor type
Government body
Name
Melbourne Health
Address
Country
Australia
Secondary sponsor category [1] 1361 0
None
Name [1] 1361 0
Nil
Address [1] 1361 0
Country [1] 1361 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2977 0
Melbourne Health-Royal Melbourne Hospital
Ethics committee address [1] 2977 0
Ethics committee country [1] 2977 0
Australia
Date submitted for ethics approval [1] 2977 0
Approval date [1] 2977 0
Ethics approval number [1] 2977 0
2006.058

Summary
Brief summary
To test whether six months' oral treatment with unregistered drug MKTVIF75HV improves magnetic resonance imaging brain scans in people with relapsing remitting multiple sclerosis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27967 0
Address 27967 0
Country 27967 0
Phone 27967 0
Fax 27967 0
Email 27967 0
Contact person for public queries
Name 10495 0
Dr Mark Stein
Address 10495 0
Department of Diabetes and Endocrinology
The Royal Melbourne Hospital
Parville
Victoria 3050
Country 10495 0
Australia
Phone 10495 0
+61 3 93427365
Fax 10495 0
Email 10495 0
[email protected]
Contact person for scientific queries
Name 1423 0
Dr Mark Stein
Address 1423 0
Department of Diabetes and Endocrinology
The Royal Melbourne Hospital
Parkville
Victoria 3050
Country 1423 0
Australia
Phone 1423 0
+61 3 93427365
Fax 1423 0
Email 1423 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
SourceTitleYear of PublicationDOI
EmbaseVitamin D for the treatment of multiple sclerosis: a meta-analysis.2018https://dx.doi.org/10.1007/s00415-018-9074-6
EmbaseVitamin D in Neurological Diseases.2023https://dx.doi.org/10.3390/ijms24010087
EmbaseClinical and Imaging Outcomes after Vitamin D Supplementation in Patients with Multiple Sclerosis: A Systematic Review.2023https://dx.doi.org/10.3390/nu15081945
Dimensions AIA randomized trial of high-dose vitamin D2 in relapsing-remitting multiple sclerosis2011https://doi.org/10.1212/wnl.0b013e3182343274
N.B. These documents automatically identified may not have been verified by the study sponsor.