Posted by: Thixia | June 7, 2008

Maestro and Mindset Studies Update

Maestro 01

 

 

Indication

 

Secondary Progressive Multiple Sclerosis

 

 

Stage

 

Phase II/III

 

 

Location of Study

 

Canada and Europe 47 trial sites in 10 countries

 

 

Description

 

The trial is designed to evaluate the safety and efficacy of MBP8298 in patients with secondary progressive MS. The trial is a randomized, double-blind study with the primary clinical endpoint defined as a statistically and clinically significant increase in the time to progression of the disease as measured by the Expanded Disability Status Scale (EDSS), in patients with HLA-DR2 and/or HLA-DR4 immune response genes. Time to disease progression in patients with other HLA-DR types will be assessed separately as an exploratory arm of the same study.

 

In April 2007 the independent Data Safety Monitoring Board completed an interim safety analysis on the first 100 patients enrolled and recommended the trial continue per the protocol. The next interim analysis, targeted for mid-2008, will look at both safety and efficacy of the first 200 patients who have completed 24 months of the clinical trial. Full analysis is targeted for 2009.

 

 

Status

 

The trial is fully recruited. Thank you to all participating patients and investigators.

 

 

Maestro 02

 

 

Indication

 

Secondary Progressive Multiple Sclerosis  

 

 

 

Stage

 

Open-label, follow-on trial

 

 

Location of Study

 

Canada and Europe 48 trial sites in 10 countries

 

 

Description

 

Eligible patients who have successfully completed the blinded, placebo controlled MAESTRO-01 trial, may choose to receive MBP8298 on an un-blinded basis in MAESTRO-02 regardless of whether they were previously on placebo or drug. The trial will primarily evaluate the long-term safety of MBP8298.

 

 

 

Maestro 03

 

 

Indication

 

Secondary Progressive Multiple Sclerosis

 

 

Stage

 

Phase III

 

 

Location of Study

 

United States

 

 

Description

 

The pivotal phase III clinical trial in the US will be evaluating MBP8298 for the treatment of secondary progressive multiple sclerosis. The trial is a randomized, double-blind study enrolling approximately 510 patients who will be administered either MBP8298 or placebo intravenously every six months for a period of two years. The primary clinical endpoint for the trial is defined as a statistically and clinically significant increase in the time to progression of the disease as measured by the Expanded Disability Status Scale (EDSS), in patients with HLA-DR2 and/or HLA-DR4 immune response genes (up to 75% of all MS patients are HLA-DR2 and/or HLA-DR4 positive).

 

 

Status

 

For enrolment information please visit: http://www.clinicaltrials.gov/ct/show/NCT00468611?order=1

 

 

 

Mindset 01

 

 

Indication

 

Relapsing-Remitting Multiple Sclerosis

 

 

Stage

 

Phase II

 

 

Location of Study

 

Europe 24 sites in 6 countries

 

 

Description

 

The MINDSET-01 clinical trial is a fifteen month, double-blind, placebo-controlled trial. The trial will be followed by a 12 month active treatment open label extension period. The objectives of the study are to demonstrate safety and efficacy of MBP8298 versus placebo as measured by relapse rate, MRI activity and disease progression.

 

 

Status

 

The trial is fully recruited. Thank you to all participating patients and investigators.

 

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