A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of BIIB122/DNL151 in Participants With Parkinson's Disease and Pathogenic LRRK2 Variants

Status: Terminated
Location: See all (27) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

In this study, researchers will learn more about a study drug called BIIB122 in participants with early-stage Parkinson's disease (PD). The study will focus on participants with a specific genetic variant in their LRRK2 gene. The main question researchers are trying to answer is if taking BIIB122 slows the worsening of PD more than placebo in the early stages of PD. To help answer this question, researchers will use a questionnaire called the Movement Disorder Society-Unified Parkinson's Disease Rating Scale, also known as the MDS-UPDRS. * The MDS-UPDRS measures impairment and disability in people living with PD. It was created in the 1980s and is one of the most used rating scales for PD symptoms. * The MDS-UPDRS has 4 parts, and a higher score means more severe PD symptoms. * Part I assesses non-motor experiences of daily living, including but not limited to memory loss, problems sleeping, pain, depression, and anxiety. * Part II measures motor experiences of daily living. * Part III is the results of a motor symptoms exam by a medical professional. * Part IV records PD complications caused by motor symptoms. Researchers will also learn more about the safety of BIIB122. A description of how the study will be done is given below. * Participants will take BIIB122 or a placebo as tablets by mouth. A placebo looks like the study drug but contains no real medicine. * Participants will be in the study for 103 weeks to 187 weeks. This includes the screening and follow-up periods. * Participants will take BIIB122 or placebo 1 time a day for 96 to 180 weeks. * Participants can continue to take certain medications for PD. Participants must be on the same dose of medication for at least 90 days before the study begins. * Participants will visit the clinic less often as the study continues, ranging every 4 weeks to every 24 weeks.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 80
Healthy Volunteers: f
View:

• Clinical diagnosis of PD meeting the Movement Disorder Society Clinical Diagnostic Criteria within 5 years of the Screening Visit, inclusive, and at least 30 years of age at the time of diagnosis

• Modified Hoehn and Yahr scale (mHY), Stages 1 to 2.5 (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 presence of a pathogenic leucine-rich repeat kinase 2 (LRRK2) variant

Locations
United States
California
University of California San Francisco (UCSF)
San Francisco
Colorado
University of Colorado
Aurora
Rocky Mountain Movement Disorders Center, PC
Englewood
Florida
Parkinson's Disease and Movement Disorders Center
Boca Raton
USF Health Byrd Institute
Tampa
Kansas
University of Kansas Medical Center Research Institute, Inc.
Kansas City
Massachusetts
Massachusetts General Hospital
Boston
New York
Mount Sinai Beth Israel
New York
Weill Medical College of Cornell University
New York
Pennsylvania
Pennsylvania Hospital
Philadelphia
Washington
Evergreen Hospital Medical Center
Kirkland
Inland Northwest Research
Spokane
Other Locations
France
Centre Hospitalier Universitaire de Lyon-Hospices Civils de Lyon-Hopital Pierre Wertheimer
Bron
Hôpital de la Timone
Marseille
Groupe Hospitalier Pitie-Salpetriere
Paris
CHU Rennes - Hopital Pontchaillou
Rennes
Hopital Purpan
Toulouse
Germany
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden
Universitaetsklinikum Tuebingen
Tübingen
Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan
Spain
Hospital Clinic de Barcelona
Barcelona
Hospital Universitari Vall d'Hebron
Barcelona
Hospital Universitario Donostia
Donostia / San Sebastian
Hospital General de Catalunya
Sant Cugat Del Vallès
Hospital Universitario Marques de Valdecilla
Santander
Hospital Universitario Virgen del Rocio
Seville
United Kingdom
Ninewells Hospital
Dundee
Time Frame
Start Date: 2022-08-26
Completion Date: 2023-07-27
Participants
Target number of participants: 7
Treatments
Experimental: BIIB122 225 mg
Participants will receive 225 mg of BIIB122 tablets, orally, once daily (QD) for up to 180 weeks.
Placebo_comparator: BIIB122-Matching Placebo
Participants will receive BIIB122-matching placebo tablets, orally, QD for up to 180 weeks.
Sponsors
Leads: Biogen
Collaborators: Denali Therapeutics Inc.

This content was sourced from clinicaltrials.gov