PADOVA · BN42358

Research analyzing the intravenous administration of prasinezumab in people with early-stage Parkinson's disease to assess its safety and therapeutic efficacy.

A phase IIb, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of intravenous prasinezumab in participants with early parkinson's disease. Eudra CT 2020-004997-23

Sponsor: ROCHE

Phase: II

Status: Follow-up

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Public study eligibility criteria

Inclusion

  • 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 with stable doses for at least 3 months prior to baseline
  • A diagnosis of PD for at least 3 months to maximum 3 years at screening
  • Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV score of 0 at screening and prior to randomization
  • Hoehn and Yahr (H&Y) Stage I or II in OFF medication state at screening and prior to randomization
  • Dopamine transporter imaging with single photon emission computed tomography (DaT-SPECT) imaging consistent with dopamine transporter deficit, as assessed by the central reader

Exclusion

  • Medical history indicating a Parkinsonian syndrome other than idiopathic PD
  • Diagnosis of PD dementia
  • Diagnosis of a significant neurologic disease other than PD
  • Within the last year, unstable or clinically significant cardiovascular disease
  • Uncontrolled hypertension