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

  • STATUS
    Recruiting
  • End date
    Dec 2, 2023
  • participants needed
    82
  • sponsor
    Biogen
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Updated on 16 November 2022
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dyskinesia

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.

Description


Details
Condition Parkinson's disease, parkinson disease, Parkinson's Disease
Treatment Placebo, BIIB094
Clinical Study IdentifierNCT03976349
SponsorBiogen
Last Modified on16 November 2022

Eligibility

 Yes No Not Sure

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

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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