The Myer Foundation Study into Multiple Sclerosis

A randomized placebo controlled double blind pilot trial of unregistered drug MKTVIF75HV on brain magnetic resonance imaging indices in multiple sclerosis

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12606000359538

Acronym

HREC 2006.058

Enrollment

Registered

2006-08-18

Start date

2006-08-24

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Relapsing remitting multiple sclerosis, gadolinium enhancing lesion(s) on screening brain MRI scan with triple dose gadolinium.

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.

Outcome results