On the subject of Guilford Pharmaceutical drugs that I’ve worked on, the second NIND NET-PD trial has been published, a futility design that included GPI-1485.
A randomized clinical trial of coenzyme Q10 and GPI-1485 in early Parkinson disease — The NINDS NET-PD Investigators 68 (1): 20 — Neurology: “Coenzyme Q10 and GPI-1485 may warrant further study in Parkinson disease, although the data are inconsistent. ”
This trial was independently conducted by NINDS. We supplied the drug. Their results in untreated patients were consistent with our own 2 year long study of patients who were already on dopamine agonist monotherapy. There are important lessons to be learned from these studies about the challenges of designing studies to test disease modifying drugs in Parkinson’s Disease and other neurodegenerative diseases.
