A Study to Determine the Efficacy and Safety of BIIB122 in Participants with Parkinson’s Disease

Overview

About this study

The purpose of this study is to determine the effectiveness and safety of BIIB122 225 mg compared with placebo to treat Parkinson's disease.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Key Inclusion Criteria:

- Clinical diagnosis of PD meeting the Movement Disorder Society Clinical Diagnostic
Criteria within 2 years of the Screening Visit, inclusive, and at least 30 years of
age at the time of diagnosis.

- Modified Hoehn and Yahr scale stages 1 to 2 (in OFF state), inclusive, at screening.

- MDS-UPDRS Parts II and III (in OFF state) combined score ≤ 40
at screening.

- Screening genetic test results verifying the absence of a pathogenic leucine-rich
repeat kinase 2 (LRRK2) variant. Confirmation of this eligibility requirement may come
from an accredited genetic test that includes all exclusionary LRRK2 genetic variants.

Key Exclusion Criteria:

- Clinically significant neurological disorder other than PD, including but not limited
to stroke, dementia, or seizure, within 5 years of screening visit, in the opinion of
the Investigator.

- Clinical evidence of atypical parkinsonism (e.g., multiple-system atrophy or
progressive supranuclear palsy) or evidence of drug-induced parkinsonism.

- Montreal Cognitive Assessment (MoCA) score < 24 at the screening visit.

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

Eligibility last updated 10/27/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Erika Driver-Dunckley, M.D.

Contact us for the latest status

Contact information:

Erica Boyd R.N.

(480) 342-1316

Boyd.Erica@mayo.edu

More information

Publications

Publications are currently not available