Summary

for people ages 40-80 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

To evaluate the dose-related safety of BIIB054, to evaluate the pharmacodynamic effects of BIIB054 on the integrity of nigrostriatal dopaminergic nerve terminals, to assess the pharmacokinetic (PK) profile of BIIB054 and to evaluate the immunogenicity of BIIB054.

Official Title

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

Keywords

Parkinson's Disease BIIB054 Alpha-synuclein Alpha synuclein Parkinson Disease BIIB054 250 mg BIIB054 1250 mg BIIB054 3500 mg

Eligibility

You can join if…

Open to people ages 40-80

  • Diagnosed with Parkinson's disease (PD) within a maximum of 3 years prior to Screening.
  • Score of ≤2.5 on the Modified Hoehn and Yahr Scale.
  • Has not received any medication for the treatment of the motor symptoms of PD for at least 12 weeks prior to Day 1 and, in the opinion of the Investigator, is not expected to require PD treatment for at least 6 months following Day 1. Maximum total duration of prior PD regimens should not exceed 30 days. Stable (at least 8 weeks) dosages of medications that are used to treat conditions other than PD tremor are allowed.Further guidance will be provided by the study's Medical Monitor on a case by case basis.
  • Screening dopamine transporter (DaT)/ single-photon emission computed tomography(SPECT) results consistent with neurodegenerative Parkinsonism (central reading).
  • All women of childbearing potential and all men must practice highly effective contraception during the study and for 6 months after their last dose of study treatment.

You CAN'T join if...

  • Presence of freezing of gait.
  • MOCA score <23 or other significant cognitive impairment or clinical dementia that, in the opinion of the Investigator, would interfere with study evaluation.
  • History of or screening brain magnetic resonance imaging (MRI) scan indicative of clinically significant abnormality, as read by central reader.
  • History of severe allergic or anaphylactic reactions, or history of hypersensitivity to BIIB054 or any of the inactive ingredients in the drug product or to radioligands or iodine used in the study.
  • Participation in any active immunotherapy study targeting alpha-synuclein.
  • Use of allowed medications not previously specified at doses that have not been stable for at least 8 weeks before Day 1, and/or that are not expected to remain stable for the duration of the study.
  • Clinically significant abnormal laboratory test values at Screening, as determined by the Investigator.
  • Blood donation (1 unit or more) within 8 weeks before Day 1 (must also refrain from donating blood for the duration of the study).

NOTE : Other protocol defined Inclusion/Exclusion criteria may apply

Locations

  • University of California San Francisco Medical Center in progress, not accepting new patients
    San Francisco California 94158 United States
  • Banner Sun Health Research Institute in progress, not accepting new patients
    Sun City Arizona 85351 United States
  • St. Joseph's Hopsital & Medical Center- Barrow Neurological Institute in progress, not accepting new patients
    Phoenix Arizona 85013 United States
  • Research Site in progress, not accepting new patients
    Kirkland Washington 98034 United States
  • Inland Northwest Research in progress, not accepting new patients
    Spokane Washington 99204 United States
  • University of Colorado Health in progress, not accepting new patients
    Aurora Colorado 80045 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Biogen
Links
Study Website
Fox Trial Finder
ID
NCT03318523
Phase
Phase 2
Study Type
Interventional
Last Updated
August 31, 2018