Phase 3 study of isradipine as a disease modifying agent in patients with early Parkinson's disease (STEADY-PD III): Baseline characteristics and study update

The American Academy of Neurology (AAN) 70th Annual MeetingT Simuni, R Holloway, D Oakes, K Biglan, C Lungu | April 23, 2018

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Summary: Researchers presented an update of results from the NINDS-funded STEADY-PD III trial, a 36-month, phase 3, parallel group, placebo-controlled study evaluating the efficacy of isradipine 10 mg daily as a disease-modifying agent in early PD, being conducted at 54 Parkinson Study Group sites in US and Canada. This trial is now fully enrolled and maintains high retention despite 3-year duration of intervention. Final study results are expected in winter 2019. According to the researchers, STEADY-PD III is  a unique opportunity to evaluate the potential impact of a novel therapy to slow progression of PD disability and provide clinically meaningful benefits.

Methods:

  • Researchers reported that enrollment of 336 participants was 6-months ahead of schedule and participant retention has been excellent.
  • The first study participant enrolled in November 2014 and the last participant is anticipated to
    complete the study in November 2018.
  • The primary outcome of the study is the change in the Unified Parkinson Disease Rating Scale (UPDRS) Part I-III score as measured in the ON state at month 36, in the active arm compared toplacebo.
  • Secondary outcome measures include time to initiation/use of dopaminergic therapy;
    time to onset of motor complications; change in non-motor disability, and a spectrum of other PD motor and non-motor outcome measures.

Results:

  • Researchers report that, as of October 13, 2017, of the 336 total participants enrolled, 327 are active in the study; (98% retention) and 315 are on study drug.
  • Nine patients have prematurely withdrawn from the study.
  • Researchers report 48 serious adverse events have occurred, of which 3 are possibly related to study drug, and 2 deaths ( unrelated to study drug).
  • A total of 278 (83%) participants have started PD symptomatic therapy.

This study is supported by the NINDS. 

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