The greatest unmet need for people with Parkinson's disease (PD) is a therapy to slow or stop the disease in its tracks. Novel disease-modifying approaches are gaining momentum in clinical trials, but many face delays because of a lack of volunteers. Disease-modifying trials can be lengthy and complex, and many may seek a narrowly defined population of newly diagnosed individuals who have not yet started Parkinson's treatments.
One such study is STEADY-PD III, a Phase III trial evaluating the ability of isradipine (a blood pressure drug) to slow or stop PD progression. This National Institutes of Health (NIH)-funded study, however, completed recruitment six months ahead of schedule, driving a potential new PD therapy forward faster and setting precedent for future investigations.
A paper in the Journal of Parkinson's Disease describes how investigators enrolled 336 people with early-stage PD across 57 sites in the United States and Canada at a record pace. A Recruitment Committee comprised of key stakeholders, including representatives from MJFF, developed a comprehensive strategy involving a three-pronged approach:
- Modification of study eligibility criteria and protocol to increase potential volunteers and lessen participant burden (while maintaining scientific rigor),
- Competitive selection of clinical trial sites and provision of materials to facilitate patient and physician awareness and engagement, and
- Expanded participant outreach, both in-person and online. Fox Trial Finder, MJFF's online clinical trial matching tool that matches eligible participants with recruiting trials, helped cultivate a greater online presence.
Researchers also emphasized strategies to maximize outreach to minority populations, a historical challenge in Parkinson's studies. This approach helped the trial meet its minority recruitment goal of 10 percent.
Faster recruitment for Parkinson's trials means researchers may speed the development of urgently needed therapies. The successful, patient-centric design of STEADY-PD III helped expedite the study and this may serve as a model for other investigations.
Isradipine is approved by the U.S. Food and Drug Administration (FDA) to treat high blood pressure. Pre-clinical studies and an MJFF-funded Phase II trial demonstrated isradipine has potential to prevent death of dopamine-producing cells and slow Parkinson's progression. An example of a repurposed therapy in PD, isradipine must still undergo rigorous testing to prove it is safe and efficacious for people with Parkinson's.
https://www.michaeljfox.org/foundation/news-detail.php?record-pace-recruitment-for-steady-pd-iii-lays-foundation-for-other-investigations
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