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Looking for participantsPhase3

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

Sponsor: Hoffmann-La Roche

NCT ID: NCT07174310

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Prasinezumab (drug), Placebo (drug)
How long the study runs
Study runs about 67 months (dates as stated)
About the drug or intervention
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
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
50 Years to 85 Years
Who
All
Number of participants
900
Started
2025-11-24
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for parkinson's disease
  • • Phase3 - 900 participants
  • • 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

Who can take part?

  • • Ages 50 Years to 85 Years
  • • Diagnosed with parkinson's disease

Where?

  • • Dundee - Ninewells Hospital, Dundee- Scotland
  • • Exeter - Royal Devon and Exeter Hospital (Wonford)
  • • London - Royal London Hospital
  • • London - Charing Cross Hospital
  • • +3 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Parkinson's Disease

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 50 Years - 85 Years
  • Who can join: All genders

What the study is looking for

  • ✓Body weight within 40-110 kilograms (kg) (88-242 pounds \[lbs\]) and a body mass index within the range 18-34 kg/m2
  • ✓Diagnosis of idiopathic PD based on Movement Disorder Society (MDS) criteria
  • ✓Has received monotherapy treatment
  • ✓An MDS-UPDRS Part IV score of 0 at screening and prior to randomization
  • ✓Hoehn and Yahr (H\&Y) Stage 1 or 2 off medication at screening and prior to randomization

Who cannot take part

  • ✗Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which...
  • ✗Medical history indicating a parkinsonian syndrome other than idiopathic PD
  • ✗Diagnosis of a significant neurologic disease other than PD
  • ✗Chronic uncontrolled hypertension
See the full criteria
Inclusion Criteria: * Body weight within 40-110 kilograms (kg) (88-242 pounds \[lbs\]) and a body mass index within the range 18-34 kg/m2 * Diagnosis of idiopathic PD based on Movement Disorder Society (MDS) criteria * Has received monotherapy treatment * An MDS-UPDRS Part IV score of 0 at screening and prior to randomization * Hoehn and Yahr (H\&Y) Stage 1 or 2 off medication at screening and prior to randomization * Agreement to adhere to the contraception requirements Exclusion Criteria: * Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which contraception is required * Medical history indicating a parkinsonian syndrome other than idiopathic PD * Diagnosis of a significant neurologic disease other than PD * Chronic uncontrolled hypertension

Where Is This Study? (7 UK sites)

Ninewells Hospital, Dundee- Scotland

Dundee DD2 1SY, United Kingdom

Recruiting
Hospital R&D contact (matched)

Jennifer McLean

jennifer.mclean@health.scot.nhs.uk0131 537 4718

Royal Devon and Exeter Hospital (Wonford)

Exeter EX2 5DW, United Kingdom

Recruiting
Hospital R&D contact (matched)

Samantha Smart

rduh.research-eastern@nhs.net01392 406075

Royal London Hospital

London E1 1FR, United Kingdom

Recruiting
Hospital R&D contact (matched)

Natasha Ajraam

rf-tr.randd@nhs.net020 375 82150

Charing Cross Hospital

London W6 8RF, United Kingdom

Recruiting

Campus for Ageing and Vitality

Newcastle NE4 5PL, United Kingdom

Recruiting

Oxford University Hospitals NHS Foundation Trust

Oxford OX3 7LE, United Kingdom

Recruiting
Hospital R&D contact (matched)

Shahista Hussain

ouhtma@ouh.nhs.uk---

Plymouth Hospitals NHS Trust - Derriford Hospital

Plymouth,Devon PL6 8DH, United Kingdom

Recruiting
Hospital R&D contact (matched)

R&D Manager

plh-tr.RD-office@nhs.net01752 431776

How to Get in Touch

Reference Study ID Number: BN44715 https://forpatients.roche.com/ No attachments to email below.

Sponsor contact

CONTACT

888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

Sponsor contact

CONTACT

Data sourced from ClinicalTrials.gov · Last verified: 2026-10