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news.Avicena Group said that the National Institute of Neurological Disorders and Stroke (NINDS) has initiated patient enrollment in a phase III efficacy trial of PD-02, the company's Parkinson's disease drug candidate.
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PD-02 is an ultra-pure form of creatine made under strictly controlled drug manufacturing guidelines to not contain harmful neurotoxins that may be present in common types of creatine.
The NINDS has agreed to provide complete funding for the five-year trial to evaluate PD-02's potential to slow the progression of Parkinson's disease. Designed as a double-blinded and placebo-controlled protocol, the trial is expected to enroll more than 1,720 Parkinson's patients at over 50 trial sites across the US and Canada.
Belinda Tsao-Nivaggioli, Avicena's CEO, said: “The trial represents the world's largest clinical study in Parkinson's disease in terms of patient enrollment and is also one of the largest studies of Parkinson's disease undertaken by the NINDS.”