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

Last updated: November 16, 2022
Sponsor: Biogen
Overall Status: Active - Recruiting

Phase

1

Condition

Parkinson's Disease

Treatment

BIIB094

Placebo

Clinical Study ID

NCT03976349
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 and dated informed consent and authorization to use confidential health information in accordance with national and local participant privacy regulations.
  • Diagnosed with PD within 7 years at the time of initial enrollment (i.e., at time of SAD enrollment for rollover participants), without major motor fluctuations or dyskinesia that may interfere with study treatment and assessments in the opinion of the investigator after consultation with the Sponsor.
  • Modified Hoehn and Yahr Stage ≤ 3.

Key

Exclusion

Exclusion Criteria:

  • Montreal Cognitive Assessment (MoCA) score less than (<) 23, dementia, or other significant cognitive impairment that, in the opinion of the Investigator, would interfere with study evaluation.
  • History of any brain surgery for PD or a history of focused ultrasound treatment at any 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, or clinically significant conduction abnormalities within 1 year before Screening.
  • Poorly controlled diabetes mellitus, as defined by having dosage adjustment of diabetic medication within 3 months before dosing (Day 1) or glycosylated hemoglobin value 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: 82
Treatment Group(s): 2
Primary Treatment: BIIB094
Phase: 1
Study Start date:
August 12, 2019
Estimated Completion Date:
December 02, 2023

Study Description

Connect with a study center

  • Montreal Neurological Institute and Hospital

    Montreal, Quebec QC H3A 2B4
    Canada

    Active - Recruiting

  • Sourasky Medical Center

    Tel-Aviv, 64239
    Israel

    Active - Recruiting

  • St. Olav University Hospital

    Trondheim, Trøndelag 7030
    Norway

    Active - Recruiting

  • Laboratorios de Investigación Biocruces 3.

    Barakaldo, 48903
    Spain

    Active - Recruiting

  • Laboratorios de Investigación Biocruces 3., Hospital de Cruces

    Barakaldo, 48903
    Spain

    Active - Recruiting

  • Hospital Clinic de Barcelona

    Barcelona, 8036
    Spain

    Active - Recruiting

  • Hospital General de Catalunya

    Barcelona, 08195
    Spain

    Active - Recruiting

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007
    Spain

    Active - Recruiting

  • Research Site

    Sevilla,
    Spain

    Active - Recruiting

  • The National Hospital for Neurology and Neurosurgery [UCLH]

    London, WC1N 3BG
    United Kingdom

    Active - Recruiting

  • Northwestern University Feinberg School of Medicine

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Northwestern University PD and Movement Disorders Center

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Quest Research Institute

    Farmington Hills, Michigan 48334
    United States

    Active - Recruiting

  • The Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Oregon Health & Science University (OHSU)

    Portland, Oregon 97239
    United States

    Active - Recruiting

  • Oregon Health and Science University

    Portland, Oregon 97239
    United States

    Active - Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

  • Alliance for Multispecialty Research

    Knoxville, Tennessee 37920
    United States

    Active - Recruiting

  • Alliance for Multispecialty Research NOCCR/VRG

    Knoxville, Tennessee 37920
    United States

    Active - Recruiting

  • Inland Northwest Research

    Spokane, Washington 99202
    United States

    Active - Recruiting

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