COS 2 center recruitment has begun and will continue until all sites have reached institutional approval status

As many of you know, the last visit for the first International Clinical Outcome Study for Dysferlinopathy (i.e. COS) occurred at the end of March 2018.  For a summary of this first study and information about what we have learned and are continuing to learn visit the “What are we learning?” section below.

With the end of the first COS study, we are now looking to the future and what more is needed to prepare us for clinical trials in dysferlinopathy. This led to the development of COS2, which is an extension of the COS study. The main objectives of COS2 are to validate the findings from COS through further evaluation of the current COS patients and the recruitment of new participants, to better understand the transition from ambulant to non-ambulant, refine subgroup characteristics, and identify early indicators/predictors of decline.

COS2 will evaluate 200 patients at 4 visits over 2 years using the best assessments from COS and the evaluation of some new assessments.  These visits will occur at 15 sites in 8 countries.  Please note that if you participated in the original COS study you are NOT automatically part of the COS2 study.  Both original COS participants and new participants must contact the relevant COS2 site and go through the recruitment process if they are interested in participating.

Each COS 2 site must individually get approval and sign off from their institutional review board/regulatory and ethics departments to be given clearance to begin the study. This approval process is done independently of the Jain Foundation.  The site is not able to talk to patients about the study or recruit for the study until these approvals are obtained.

For information about the study, eligibility criteria, assessments, and location of COS2 clinics please visit the sections below or contact us at cos@jain-foundation.org or 425-882-1492.