A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BIIB094 in Adults With Parkinson's Disease

Last updated: April 25, 2025
Sponsor: Biogen
Overall Status: Completed

Phase

1

Condition

Parkinson's Disease

Dyskinesias

Treatment

BIIB094

Placebo

Clinical Study ID

NCT03976349
254PD101
2018-002995-42
  • Ages 35-80
  • All Genders

Study Summary

The primary objective of this study is to evaluate the safety and tolerability of single and multiple doses of BIIB094 administered via intrathecal (IT) injection to participants with Parkinson's Disease (PD). The secondary objective of this study is to evaluate the pharmacokinetic (PK) profile of BIIB094.The study is open for PD patients with verified presence or absence of variations in the leucine-rich repeated kinase 2 (LRRK2) gene, but also for patients without any verified PD-related genetic variant.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Ability to understand the purpose and risks of the study and provide signed anddated informed consent and authorization to use confidential health information inaccordance with national and local participant privacy regulations.

  • Diagnosed with PD within 7 years at the time of initial enrollment (i.e., at time ofSAD enrollment for rollover participants), without major motor fluctuations ordyskinesia that may interfere with study treatment and assessments in the opinion ofthe investigator after consultation with the Sponsor.

  • Modified Hoehn and Yahr Stage ≤ 3.

Exclusion

Key Exclusion Criteria:

  • Montreal Cognitive Assessment (MoCA) score less than (<) 23, dementia, or othersignificant cognitive impairment that, in the opinion of the Investigator, wouldinterfere with study evaluation.

  • History of any brain surgery for PD or a history of focused ultrasound treatment atany time; or history of neuromodulation procedures.

  • Transient ischemic attack or stroke or any unexplained loss of consciousness within 1 year before Screening.

  • History of unstable angina, myocardial infarction, chronic heart failure, orclinically significant conduction abnormalities within 1 year before Screening.

  • Poorly controlled diabetes mellitus, as defined by having dosage adjustment ofdiabetic medication within 3 months before dosing (Day 1) or glycosylated hemoglobinvalue greater than or equal to (≥) 8 percent (%) at Screening.

  • History or positive test result at Screening for human immunodeficiency virus.

  • History or positive test result at Screening for hepatitis C virus antibody.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 62
Treatment Group(s): 2
Primary Treatment: BIIB094
Phase: 1
Study Start date:
August 12, 2019
Estimated Completion Date:
August 12, 2024

Connect with a study center

  • Research Site

    Toronto, Ontario
    Canada

    Site Not Available

  • Montreal Neurological Institute and Hospital

    Montreal, Quebec QC H3A 2B4
    Canada

    Site Not Available

  • Sourasky Medical Center

    Tel-Aviv, 64239
    Israel

    Site Not Available

  • Neuro-SysMed Center

    Bergen, 5053
    Norway

    Site Not Available

  • St. Olav University Hospital

    Trondheim, 7030
    Norway

    Site Not Available

  • Laboratorios de Investigación Biocruces 3., Hospital de Cruces

    Barakaldo, Bizkaia 48903
    Spain

    Site Not Available

  • Hospital General de Catalunya

    Barcelona, Vizcaya 08195
    Spain

    Site Not Available

  • Hospital Clinic de Barcelona

    Barcelona, 08036
    Spain

    Site Not Available

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007
    Spain

    Site Not Available

  • Research Site

    Sevilla,
    Spain

    Site Not Available

  • Queen Square (Neurology) CRF Site Institute of Neurology & the National Hospital for Neurology and Neurosurgery UCLH

    London, WC1N 3BG
    United Kingdom

    Site Not Available

  • Northwestern University PD and Movement Disorders Center

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Quest Research Institute

    Farmington Hills, Michigan 48334
    United States

    Site Not Available

  • The Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Oregon Health and Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Alliance for Multispecialty Research

    Knoxville, Tennessee 37920
    United States

    Site Not Available

  • Inland Northwest Research

    Spokane, Washington 99202
    United States

    Site Not Available

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