PARAISO · BN44715
A clinical trial to assess the safety and efficacy of intravenous prasinezumab treatment in participants who are in an early stage of Parkinson's disease.
A phase III, randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy and safety of intravenous prasinezumab in participants with early-stage Parkinson's disease.
Sponsor: F. Hoffmann-La Roche Ltd
Phase: III
Status: Follow-up
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Public study eligibility criteria
Inclusion
- Diagnosis of idiopathic PD based on Movement Disorder Society (MDS) criteria (Postuma et al. 2015) with bradykinesia plus one of the other cardinal signs of PD (resting tremor, rigidity), without any other known or suspected cause of parkinsonism
- Has received PD medication for at least 3 months prior to baseline
- 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
- Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which contraception is required Participants of childbearing potential must have a negative serum pregnancy test result during screening prior to initiation of study treatment
- Medical history indicating a parkinsonian syndrome other than idiopathic PD
- Diagnosis of a significant neurological disease other than PD
- Uncontrolled hypertension