A Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants with Early Parkinson's Disease
- Conditions
- Early Parkinson's diseaseMedDRA version: 20.0Level: PTClassification code 10061536Term: Parkinson's diseaseSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2020-004997-23-ES
- Lead Sponsor
- Roche Farma S. A. U. que realiza el ensayo en España y que actúa como representante F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 575
• Age >=50-85 years at time of signing the Informed Consent Form
• Diagnosis of idiopathic Parkinson's disease (PD) based on Movement disorder society (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 for at least 6 months, with stable doses for 3 months prior to baseline
• A diagnosis of PD for at least 6 months to maximum 3 years at screening
• Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV score= 0
• Hoehn and Yahr (H&Y) Stage I or II in ON and OFF states
• 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 259
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 316
• Medical history indicating a Parkinsonian syndrome other than idiopathic PD
• Diagnosis of PD dementia
• Diagnosis of a significant central nervous system (CNS) disease other than Parkinson’s disease
• 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 MRI
• Any contraindications to DaT-SPECT imaging
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of prasinezumab compared with placebo on basis of time to meaningful progression on motor signs of the disease;Secondary Objective: • To evaluate the efficacy of prasinezumab compared with placebo on basis of time-to-worsening of patient’s motor function as reported by the patient and confirmed by the clinician, time to meaningful worsening in the overall disease as reported by the patient and by the clinician, change from baseline in motor function, change from baseline in bradykinesia and change from baseline in motor aspects of experiences of daily living <br>• To evaluate the safety of prasinezumab compared with placebo<br>• To characterize the prasinezumab pharmacokinetic (PK) profile<br>• To evaluate the immune response to prasinezumab;Primary end point(s): Time to meaningful progression on motor signs of the disease, as assessed by >5 points increase in MDS-UPDRS Part III score from baseline;Timepoint(s) of evaluation of this end point: Throughout the study
- Secondary Outcome Measures
Name Time Method