Clinical Trials

Safety and Efficacy Study of MIS416 to Treat Secondary Progressive MS

Type of Study/Intervention

Drug

Recruitment Status

Closed

Form of MS

Secondary progressive MS

Brief summary

MIS416 is microparticle derived from bacteria, combined with two immune-modifying molecules. It acts to stimulate a specific range of responses in the innate immune system.

This Phase IIB, randomised, double-blind trial will investigate the safety and efficacy of MIS416 in up to 90 participants across multiple sites in Australia. 60 patients will receive MIS416 and 30 will receive a placebo. MIS416 will be administered by once weekly intravenous infusions for 12 months.

The primary goal of the trial is to determine the efficacy and safety of MIS416 compared to patients treated with the placebo. Secondary objectives of the study are to determine the effect of MIS416 on disease activity and neurodegeneration by assessing changes in Magnetic Resonance Imaging (MRI) markers including lesions, whole brain atrophy and Magnetization Transfer Ratio, assess patient reported outcomes in relation to disability and health status; and also in a subset of patients assess the effects of MIS416 on the immune system, its metabolism and distribution in the body.

Inclusion criteria

  • A historical or current cranial MRI scan demonstrating T2-hyperintense lesions consistent with MS.
  • Has SPMS as determined by the 2010 Update to the McDonald Criteria
  • An Expanded Disability Status Scale (EDSS) of 3.0 to 6.5 at Screening.
  • Has SPMS which, in the judgment of the investigator, has been clinically active and functionally progressive within the 2 years prior to screening.
  • The absence of MS relapse for at least two years prior to Baseline.
  • Neurologically stable for at least four weeks prior to Screening.
  • Has laboratory blood test values within specified ranges three days prior to initiation of Investigational Product (see here for full details)
  • Provided written informed consent to participate

Exclusion Criteria

Exclusion criteria also apply. Please visit ClinicalTrials.Gov for full details.

Anticipated start date

September 2014

Recruitment contacts

Western Australia
Western Australian Neuroscience Research Institute
Perth, Western Australia, 6009
Susan Walters
Email: [email protected]
Phone: 08 9346 4884

Victoria
Nucleus Network, Level 5, 89 Commercial Road
Melbourne, Victoria 3004
Centre for Clinical Studies
Email: [email protected]
Phone: 1800 243 733
Tristan Iseli
Email: [email protected]

Queensland
The Wesley-St. Andrew’s Research Institute (WSARI)
Level 8 East Wing The Wesley Hospital, 451 Coronation Drive
Auchenflower, Brisbane, QLD 4066
Helen Woodhouse
Email: [email protected]
Phone: 07 3721 1523

Details of further trial sites will be provided as they become available

South Australia
PARC Clinical Research, Royal Adelaide Hospital
North Terrace Adelaide, SA 5000
Kathy Heyman
Email: [email protected]
Phone: 08 8222 2712

Further details

For full details visit the trial listing on the ClinicalTrials.gov clinical trials registry.

Region

WA/VIC/QLD/SA

Last updated

April 2016

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