A Study to Evaluate the Efficacy of Prasinezumab (RO7046015/PRX002) in Participants With Early Parkinson's Disease (PASADENA)
EU CTIS ID: 2023-504472-24-00
What this study is testing
To evaluate the efficacy of RO7046015 versus placebo at Week 52, in participants with early Parkinson’s disease (PD) (H&Y Stages I-II) who are untreated or treated with monoamine oxidase-B (MAO-B) inhibitors since baseline, as measured by change from baseline on the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS UPDRS) Total Score (sum of Parts I, II and III)
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- A screening brain DaT-SPECT consistent with PD (central reading)
- Clinical status does not require dopaminergic PD medication and is not expected to require dopaminergic treatment within 52 weeks from baseline
- If presently being treated for PD, a stable dose of MAO-B inhibitor (rasagiline or selegiline) for at least 90 days prior to baseline and not expected to change within 52 weeks.
- Idiopathic PD with bradykinesia plus one of the other cardinal signs of PD (resting tremor, rigidity) being present, without any other known or suspected cause of PD untreated or treated with MAO-B inhibitor
- A diagnosis of PD for 2 years or less at screening
- Hoehn and Yahr Stage I or II
You likely can't join if
- A diagnosis of a significant CNS disease other than Parkinson's disease; history of repeated head injury; history of epilepsy or seizure disorder other than febrile seizures as a child
- Mini Mental State Examination (MMSE) </=25
- History of or screening brain magnetic resonance imaging (MRI) scan indicative of clinically significant abnormality
- Medical history indicating a Parkinson syndrome other than idiopathic PD, including but not limited to, progressive supranuclear gaze palsy, multiple system atrophy, drug-induced parkinsonism, essential tremor, primary dystonia
- Known carriers of certain familial PD genes (as specified in study protocol)
- History of PD related freezing episodes or falls
The study team makes the final eligibility decision.
Where it's taking place
- Austria
- Germany
- France
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Austria; Germany; France; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from EU CTIS. The study team decides eligibility, and your own doctor gives medical advice.