Results from the STEADY-PD III trial that will be presented at the American Academy of Neurology Annual Meeting showed that the BP medication, isradipine, does not slow the progression of Parkinson’s disease.
Researchers showed interest in the drug following an observation that taking isradipine for elevated BP was associated with a lower risk of developing Parkinson’s disease, according to a press release. Results from animal studies were promising and a phase 2 human study did not find any safety concerns.
“Unfortunately, the people who were taking isradipine did not have any difference in their Parkinson’s symptoms over the 3 years of the study compared to people who took the placebo,” Tanya Simuni, MD, of Northwestern University Feinberg School of Medicine and member of the American Academy of Neurology, said in a press release.
STEADY-PD III was a phase 3 parallel group study that evaluated the efficacy of 10 mg daily isradipine compared with placebo over 36 months in slowing the progression of disability in patients with early stage Parkinson’s disease. The primary outcome was a change at 36 months compared with baseline on the Unified Parkinson Disease Rating Scale (UPDRS) Part I-III in the ON state.
The study included 336 patients with early Parkinson’s disease at 54 Parkinson’s Study Group sites in the United States and Canada who were enrolled between November 2014 and November 2015. Participants were 62 years old and were 0.9 years from their Parkinson’s diagnosis at the time of enrollment. The adjusted mean UPDRS I-III medications ON over 36 months showed a treatment effect of 0.27 points (P = 0.85), with a change of 2.99 points in patients taking isradipine and 3.26 points in patients the placebo.
“Of course, this is disappointing news for everyone with Parkinson’s disease and their families, as well as the research community,” Simuni said. “However, negative results are important because they provide a clear answer, especially for the drug that is commercially available. We will all continue to work to find a treatment that can slow down or even cure this disease.” – by Erin Michael
Simuni T, et al. Phase 3 study of isradipine as a disease modifying agent in patients with early Parkinson’s disease (STEADY-PD III): Final Study Results. Presented at: The American Academy of Neurology Annual Meeting; May 4-11, 2019; Philadelphia.
Disclosures: The study was supported by the National Institute of Neurological Disorders and Stroke. Simuni has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Abbvie, Acadia, Accorda, Adamas, Allergan, Anavex, Denali, the Michael J. Fox Foundation, Neurocrine, Neuroderm, Photopharmics, Revance, Sanofi, Sunovion, Takeda, Teva, US World Meds and Voyager. Simuni has received research support from Biogen, the Michael J. Fox Foundation, Neuroderm, NINDS, the Parkinson Foundation, Roche, Sanofi and Sun Pharma.