A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study, with an Active-Treatment Dose-Blinded Period, to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Subjects with Parkinson’s Disease

What we are studying

The purpose of this study is to find out what effects (good and bad) BIIB054 has on subjects and their condition (Parkinson's disease). BIIB054 is an investigational drug and has not been approved by the FDA. It is believed to work by attaching to molecules in your brain associated with Parkinson's disease, called alpha-synuclein, and preventing them from causing damage. BIIB054 will be compared to placebo and will be given by I.V. every 4 weeks.

Who is Eligible

• Genders:
  • Men
  • Women
• Races:
  • White
  • African American
  • Asian
  • American Indian or Alaska Native
  • Native Hawaiian or Pacific Islander
  • Other
• All Ethnicities
• Ages 40 - 80

Eligibility Criteria

• -Diagnosed with Parkinson's disease -Has not started or taken any treatment/medications for Parkinson's disease -No dementia or cognitive issues -No uncontrolled hypertension

What is involved

• 2 year study with I.V. infusions every 4 weeks. Study assessments include MRIs
• Datscans
• Blood draws
• Questionnaires and may include lumbar punctures.

Compensation

You will be reimbursed for approved travel expenses related to study visits.

Contact Information

Study Coordinator

Jessica Dimos

Email

jdimos@wakehealth.edu

Phone

336-716-8694

Principal Investigator

Mustafa Siddiqui, MD