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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Hoffmann-La Roche
Study ID
NCT04777331
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Prasinezumab — DRUG
    Prasinezumab will be administered as an IV infusion to participants Q4W.
  • Placebo — DRUG
    Prasinezumab placebo will be administered to participants.

Study Details

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.

Key Dates

Start date
May 5, 2021
Status verified
Mar 2026
Primary completion
Sep 11, 2024
Completion
Dec 30, 2026

Study Design

Enrollment
586 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Prasinezumab
    Participants will receive an IV infusion of prasinezumab every 4 weeks (Q4W). Participants will enter into the optional Open Label Extension (OLE) once the double-blind treatment period has completed.
  • Placebo Comparator: Placebo
    Participants will receive placebo as an IV infusion Q4W.

Primary Outcome Measure

DBT Period: Time to Confirmed Motor Progression Event Assessed by Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III [ Time Frame: From study start to end of DBT period to at least 76 weeks ]

Locations (31)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294-
Barrow Neurological InstitutePhoenixArizona85013-
Neurology Center of North Orange CountyFullertonCalifornia92835-
UC San DiegoLa JollaCalifornia92037-
Cedars Sinai Medical CenterLos AngelesCalifornia90048-
Keck School of Medicine of USCLos AngelesCalifornia90033-
University of California San FranciscoSan FranciscoCalifornia94143-
CenExel Rocky Mountain Clinical Research, LLCEnglewoodColorado80113-
Institute for Neurodegenerative DisordersNew HavenConnecticut06510-
JEM Research LLCAtlantisFlorida33462-
Parkinson's Disease and Movement Disorders Center of Boca RatonBoca RatonFlorida33486-
Renstar Medical ResearchOcalaFlorida34470-
University of South FloridaTampaFlorida33613-4706-
Charter Research - Winter Park/OrlandoWinter ParkFlorida32792-
Northwestern University Feinberg School Of MedicineChicagoIllinois60611-
Southern Illinois University, School of MedicineSpringfieldIllinois62702-
University of Kansas Medical CenterKansas CityKansas66160-
Massachusetts General HospitalBostonMassachusetts02114-2759-
Quest Research InstituteFarmington HillsMichigan48334-
Henry Ford HospitalWest BloomfieldMichigan48322-
Dent Neurological InstituteAmherstNew York14226-
Cleveland ClinicClevelandOhio44195-
The Movement Disorder Clinic of OklahomaTulsaOklahoma74136-
University Pennsylvania HospitalPhiladelphiaPennsylvania19107-
Texas Neurology PADallasTexas75206-
Baylor College of Medicine Medical CenterHoustonTexas77030-
Central Texas Neurology ConsultantsRound RockTexas78681-
University of Vermont Medical CenterBurlingtonVermont05401-
Sentara Neurology SpecialistsNorfolkVirginia23507-
EvergreenHealth Investigational Drug ServicesKirklandWashington98034-
Inland Northwest ResearchSpokaneWashington99202-

Related coverage on Hipa.ai

Find similar trials in Birmingham, AL

By condition
Parkinson's disease
By specialty
NeurologyBrain disorders
By research site
University of Alabama at Birmingham· Birmingham, ALBarrow Neurological Institute· Phoenix, AZNeurology Center of North Orange County· Fullerton, CAUC San Diego· La Jolla, CACedars Sinai Medical Center· Los Angeles, CAKeck School of Medicine of USC· Los Angeles, CA

Related Studies