A Randomized, Double-Blind, Placebo-Controlled, 52-Week Phase II Study to Evaluate the Efficacy of Intravenous RO7046015/Prasinezumab (PRX002) in Participants With Early Parkinson’s Disease With a 6-Year All-Participants-on-Treatment Extension
Sponsor:
Hoffmann-La Roche
Brief Summary:
This multicenter, randomized, double-blind, placebo-controlled, Phase 2 study will evaluate
the efficacy of intravenous prasinezumab (RO7046015/PRX002) versus placebo over 52 weeks in
participants with early Parkinson’s Disease (PD) who are untreated or treated with monoamine
oxidase B (MAO-B) inhibitors since baseline. The study will consist of three parts: a
52-week, double-blind, placebo-controlled treatment period (Part 1) after which eligible
participants will continue into an all-participants-on-treatment blinded dose extension for
an additional 52 weeks (Part 2). Participants who complete Part 2 (including the 12-week
treatment-free follow up visit assessing long term safety and efficacy of RO7046015) will be
offered participation in Part 3 (all-participants-on-RO7046015-treatment) for an additional
260 weeks.
the efficacy of intravenous prasinezumab (RO7046015/PRX002) versus placebo over 52 weeks in
participants with early Parkinson’s Disease (PD) who are untreated or treated with monoamine
oxidase B (MAO-B) inhibitors since baseline. The study will consist of three parts: a
52-week, double-blind, placebo-controlled treatment period (Part 1) after which eligible
participants will continue into an all-participants-on-treatment blinded dose extension for
an additional 52 weeks (Part 2). Participants who complete Part 2 (including the 12-week
treatment-free follow up visit assessing long term safety and efficacy of RO7046015) will be
offered participation in Part 3 (all-participants-on-RO7046015-treatment) for an additional
260 weeks.
Criteria
Inclusion Criteria:
– Idiopathic PD with bradykinesia plus one of the other cardinal signs of PD (resting
tremor, rigidity) being present, without any other known or suspected cause of PD
untreated or treated with MAO-B inhibitor
– Body weight range between: >/=45 kg/ 99 pounds (lbs) and less than or equal to (
Locations
- Neurology Center of North Orange County, Fullerton, California, United States, 92835
- Altman Clinical Translational Research Institute, La Jolla, California, United States, 92037
- USC Keck Medical Center of USC, Los Angeles, California, United States, 90033
- University of California at San Francisco, San Francisco, California, United States, 94115
- Parkinson’s Institute and Clinical Center, Sunnyvale, California, United States, 94085
