A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Hoffmann-La Roche
Study ID
NCT07174310
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Prasinezumab — DRUG
    Participants will receive Prasinezumab as an IV Infusion as per the schedule mentioned in the protocol.
  • Placebo — DRUG
    Participants will receive Placebo as an IV Infusion per the schedule mentioned in the protocol

Study Details

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of prasinezumab compared with placebo in participants with early-stage Parkinson's disease (PD) on stable symptomatic monotherapy with levodopa.

Key Dates

First listed
Sep 15, 2025
Start date
Nov 24, 2025
Status verified
Jul 2026
Primary completion
Jun 30, 2029
Completion
Jun 30, 2031

Study Design

Enrollment
900 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Prasinezumab
    Participants will receive Prasinezumab as an IV infusion in the double blind treatment period. Upon completion, eligible participants will enter into the Open Label Extension (OLE) phase.
  • Experimental: Placebo
    Participants will receive placebo as an IV Infusion.

Primary Outcome Measure

Time to Confirmed Motor Progression Event on Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score [ Time Frame: Up to at least Week 104 ]

Central Contacts

  • Reference Study ID Number: BN44715 https://forpatients.roche.com/ No attachments to email below.
    888-662-6728 (U.S. and Canada)
    [email protected]
  • Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

Locations (46)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233-
Barrow Neurological InstitutePhoenixArizona85013-
Neurology Center of North Orange CountyFullertonCalifornia92835-
UC San DiegoLa JollaCalifornia92037-
Keck School of Medicine of USCLos AngelesCalifornia900033-
UCLA Neurology Outpatient ClinicLos AngelesCalifornia90095-
Parkinson?s Research Centers of America ? Palo AltoPalo AltoCalifornia94301-
Profound Research LLC at The Neurology Center of Southern CaliforniaPasadenaCalifornia91105-
UCSF Weill Institute for NeurosciencesSan FranciscoCalifornia94158-
Rocky Mountain Movement DisordersEnglewoodColorado80113-
Institute for Neurodegenerative DisordersNew HavenConnecticut06510-
Georgetown UniversityWashington D.C.District of Columbia20007-
JEM Research LLCAtlantisFlorida33462-
Parkinson's Disease and Movement Disorders Center of Boca RatonBoca RatonFlorida33486-
K2 - VillagesLady LakeFlorida32159-
K2 Medical Research-MaitlandMaitlandFlorida32751-
Baptist Hospital of MiamiMiamiFlorida33176-
Charter Research - Winter Park/OrlandoOrlandoFlorida32803-
Hawaii Pacific NeuroscienceHonoluluHawaii96817-
Northwestern University Feinberg School Of MedicineChicagoIllinois60611-
University of Kansas Medical CenterKansas CityKansas66160-
Massachusetts General HospitalBostonMassachusetts02114-
Quest Research InstituteFarmington HillsMichigan48334-
Washington Uni School of MedicineSt LouisMissouri63110-
Cleveland Clinic Lou RuvoLas VegasNevada89106-
Renown HealthRenoNevada89502-
Hackensack University Medical Center;Department of Neurology, Neuroscience InstituteParamusNew Jersey07652-
University of New MexicoAlbuquerqueNew Mexico87106-
Dent Neurological InstituteAmherstNew York14226-
Parkinson's Research Centers of America - Long IslandCommackNew York11725-
Weill Cornell Medical CollegeNew YorkNew York10021-
Asheville NeurologyAshevilleNorth Carolina28806-
NeuroCare CenterCantonOhio44718-
Cleveland ClinicClevelandOhio44195-
The Movement Disorder Clinic of OklahomaTulsaOklahoma74136-
University Pennsylvania HospitalPhiladelphiaPennsylvania19107-
Allegheny General HospitalPittsburghPennsylvania15212-
Avera Medical GroupSioux FallsSouth Dakota57105-
Veracity NeuroscienceMemphisTennessee38157-
Vanderbilt University Medical CenterNashvilleTennessee37212-
Texas Neurology PADallasTexas75206-
Central Texas Neurology ConsultantsRound RockTexas78681-
University of Vermont Medical CenterBurlingtonVermont05401-
University of Virginia Health SystemCharlottesvilleVirginia22903-
VCU Health North HospitalRichmondVirginia23298-
West Virginia UniversityMorgantownWest Virginia26506-

Find similar trials in Birmingham, AL

Nationwide
Parkinson's disease trialsNeurology trialsBrain disorders trials
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, CAKeck School of Medicine of USC· Los Angeles, CAUCLA Neurology Outpatient Clinic· Los Angeles, CA

Related Studies