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A Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants With Early Parkinson's Disease

Active Not RecruitingPhase 2

Sponsor: Hoffmann-La Roche

Conditions: Parkinsons Disease

Interventions: Prasinezumab, Placebo

Countries: United States, Austria, Canada, France, Italy, Luxembourg, Poland, Spain

This is a multicenter, randomized, double-blind, placebo-controlled study that will evaluate the efficacy and safety of intravenous (IV) prasinezumab versus placebo in participants with Early Parkinson's Disease (PD) who are on stable symptomatic PD medication.

Eligibility overview

Sex: ALL

Age: 50 Years to 85 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Diagnosis of idiopathic PD based on MDS criteria with bradykinesia plus one of the other cardinal signs of PD (resting tremor, rigidity), without any other known or suspected cause of parkinsonism
* On symptomatic PD medication, with stable doses for at least 3 months prior to baseline
* A diagnosis of PD for at least 3 months to maximum 3 years at screening
* MDS-UPDRS Part IV score of 0 at screening and prior to randomization
* Hoehn and Yahr (H\&Y) Stage I or II in OFF medication state at screening and prior to randomization
* Dopamine transporter imaging with single photon emission computed tomography (DaT-SPECT) imaging consistent with dopamine transporter deficit, as assessed by the central reader
* No anticipated changes in PD medication from baseline throughout the study duration based on clinical status during screening
* Willingness and ability to use a smartphone application to measure PD-related symptoms for the duration of the study
* Willingness and ability to wear a smartwatch to measure PD-related motor signs

Exclusion Criteria:

* Medical history indicating a Parkinsonian syndrome other than idiopathic PD
* Diagnosis of PD dementia
* Diagnosis of a significant neurologic disease other than PD
* Within the last year, unstable or clinically significant cardiovascular disease
* Uncontrolled hypertension
* Drug and/or alcohol abuse within 12 months prior to screening, in the investigator's judgment (Nicotine is allowed, Marijuana use is not allowed)
* Clinically significant abnormalities in laboratory test results at the screening visit, including hepatic and renal panels, complete blood count, chemistry panel and urinalysis
* Allergy to any of the components of prasinezumab, a known hypersensitivity, or a previous IRR following administration of any other monoclonal antibody
* Any contraindications to obtaining a brain magnetic resonance imaging (MRI)
* Any contraindications to DaT-SPECT imaging

Locations (110)

Birmingham, Alabama, United States
Phoenix, Arizona, United States
Fullerton, California, United States
La Jolla, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
San Francisco, California, United States
Englewood, Colorado, United States
New Haven, Connecticut, United States
Atlantis, Florida, United States
Boca Raton, Florida, United States
Ocala, Florida, United States
Tampa, Florida, United States
Winter Park, Florida, United States
Chicago, Illinois, United States
Springfield, Illinois, United States
Kansas City, Kansas, United States
Boston, Massachusetts, United States
Farmington Hills, Michigan, United States
West Bloomfield, Michigan, United States
Amherst, New York, United States
Cleveland, Ohio, United States
Tulsa, Oklahoma, United States
Philadelphia, Pennsylvania, United States
Dallas, Texas, United States
Houston, Texas, United States
Round Rock, Texas, United States
Burlington, Vermont, United States
Norfolk, Virginia, United States
Kirkland, Washington, United States
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