As a result of the positive data from the PISCES II study, the FDA approved the commencement of a randomised, placebo-controlled, Phase IIb clinical trial in the US in patients living with chronic stroke disability (PISCES III). This trial will enroll approximately 110 patients across up to 40 centres, and is scheduled to begin recruitment in late 2018.
The primary efficacy objective for PISCES III will be to assess the effect of CTX drug product on the change in degree of dependency and disability from baseline as measured by the modified Rankin Scale (mRS) at 6 months post-treatment. The mRS is a well-established, 7-point, clinician-reported global measure of functional disability in patients and of their dependence upon others in carrying out activities of daily living. A 1 point improvement from baseline on the mRS is considered clinically meaningful as it represents a stroke patient’s ability to function more independently.
The target population for PISCES III will be patients, who have stabilised following an ischemic stroke 6-12 months prior to treatment, with moderate to moderately severe functional disability requiring help from others to carry out activities of daily living or to ambulate. For further information on the trial as well as to determine eligibility to participate in this trial, please visit the trial website (www.pisces3.org).