Spark

A phase 2 clinical trial for people with Parkinson’s disease

Status
Start Date
Condition
Estimated
enrollment
Age Range
Phase
Study Type

Objective

To evaluate the dose-related safety of an investigational drug (BIIB054).

The investigational drug

Data suggests that there may be a link between aggregated (clumped) forms of alpha-synuclein (α-syn) and Parkinson’s disease. So BIIB054 is a human monoclonal antibody that targets aggregated α-syn, and is being developed by Biogen for the treatment of Parkinson’s disease. Owing to the observed links between α-syn and Parkinson’s disease pathogenesis, it has become an important investigational target for potential disease-modifying treatments. Early-stage Parkinson’s disease patients were selected as the test population in this study, to determine if α-syn may potentially be more effective in modifying the course of the disease when less neuronal damage is evident and the spread of disease pathology is more limited.

Key eligibility criteria

  • Men and women
  • 40-80 years old
  • Diagnosed with clinically established Parkinson’s disease for less than 3 years with no other known or suspected cause
  • A score of 2.5 or less on the Modified Hoehn and Yahr Scale

Trial length

  • Approximately 2 years 2 months