The Myer Foundation Study into Multiple Sclerosis

Phase 3

• Conditions: Relapsing remitting multiple sclerosis; Neurological - Multiple sclerosis

• Registration Number: ACTRN12606000359538
• Lead Sponsor: Melbourne Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-08-18
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The total number of new gadolinium enhancing lesions on MRI detected during the 6 months.[The timepoints for enhancing lesion detection are the MRI timepoints noted in Intervention above; at baseline, 4, 5 and 6 months..]

Secondary Outcome Measures

Name	Time	Method
The total number of new gadolinium enhancing lesions still present at end study.[6 month timepoint.];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.[The timepoints for detection of MRI lesions are the MRI timepoints noted in Intervention above; at baseline, 4, 5 and 6 months.]