Phase 1/2a Clinical Trial of PR001A in Patients With Parkinson's Disease With at Least One GBA1 Mutation (PROPEL)

A Phase 1/2a Randomized, Double-Blind, Sham Procedure-Controlled, Ascending Dose Study to Evaluate the Safety of PR001A in Patients With Parkinson's Disease With at Least One GBA1 Mutation

Recruitment Information:

Seeking volunteers with following diagnosis: PD Study Type: Interventional
Eligible Ages: 40 - 75 Status: Recruiting
Time Since Diagnosis: Any may be eligible Study Focus:

Study Purpose:

Study PRV-PD101 is a Phase 1/2a, multicenter, randomized, double-blind, sham procedure-controlled, ascending dose, first in-human study that will evaluate the safety of intra-cisternal PR001A administration in patients with moderate to severe Parkinson's disease with at least 1 pathogenic GBA1 mutation. Two escalating dose cohorts are planned (low dose and high dose, with a sham procedure as control). The duration of the study is 5 years. During the first year, patients will be evaluated for the effect of PR001A on safety, tolerability, immunogenicity, biomarkers, and clinical efficacy measures. Patients will continue to be followed for an additional 4 years to continue to monitor safety as well as selected biomarker and efficacy measures.

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More Details

Phase: Phase 1/Phase 2 Lead Sponsor: Prevail Therapeutics
Trial ID: 006499 Sponsor Type: Industry
Primary Country: United States Additional Collaborators or Sponsors:
Estimated Enrollment: 16 Study Start Date: October 2019
Estimated Study Completion Date: August 2026 Source: ClinicalTrials.gov
Study Website:

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