Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05418673
Other study ID # 283PD302
Secondary ID 2022-000747-77
Status Terminated
Phase Phase 3
First received
Last updated
Start date August 26, 2022
Est. completion date July 27, 2023

Study information

Verified date December 2023
Source Biogen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

BIIB122 is an investigational central nervous system-penetrant small molecule inhibitor of LRRK2 kinase


Recruitment information / eligibility

Status Terminated
Enrollment 7
Est. completion date July 27, 2023
Est. primary completion date July 27, 2023
Accepts healthy volunteers No
Gender All
Age group 30 Years to 80 Years
Eligibility Key Inclusion Criteria: - 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 Key Exclusion Criteria: - Clinically significant neurologic 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 NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
BIIB122
Administered as specified in the treatment arm.
BIIB122-Matching Placebo
Administered as specified in the treatment arm.

Locations

Country Name City State
France Centre Hospitalier Universitaire de Lyon-Hospices Civils de Lyon-Hopital Pierre Wertheimer Bron Rhone
France Hôpital de la Timone Marseille Bouches-du-Rhône
France Groupe Hospitalier Pitie-Salpetriere Paris
France CHU Rennes - Hopital Pontchaillou Rennes cedex 09 Ille Et Vilaine
France Hopital Purpan Toulouse Haute Garonne
Germany Universitaetsklinikum Carl Gustav Carus TU Dresden Dresden
Germany Universitaetsklinikum Tuebingen Tuebingen Baden Wuerttemberg
Italy Fondazione IRCCS Istituto Neurologico Carlo Besta Milano
Spain Hospital Clinic de Barcelona Barcelona
Spain Hospital Universitari Vall d'Hebron Barcelona
Spain Hospital Universitario Donostia San Sebastian Guipuzcoa
Spain Hospital General de Catalunya Sant Cugat del Valles Barcelona
Spain Hospital Universitario Marques de Valdecilla Santander Cantabria
Spain Hospital Universitario Virgen del Rocio Sevilla
United Kingdom Ninewells Hospital Dundee Tayside Region
United States University of Colorado Aurora Colorado
United States Parkinson's Disease and Movement Disorders Center Boca Raton Florida
United States Massachusetts General Hospital Boston Massachusetts
United States Rocky Mountain Movement Disorders Center, PC Englewood Colorado
United States University of Kansas Medical Center Research Institute, Inc. Kansas City Kansas
United States Evergreen Hospital Medical Center Kirkland Washington
United States Mount Sinai Beth Israel New York New York
United States Weill Medical College of Cornell University New York New York
United States Pennsylvania Hospital Philadelphia Pennsylvania
United States University of California San Francisco (UCSF) San Francisco California
United States Inland Northwest Research Spokane Washington
United States USF Health Byrd Institute Tampa Florida

Sponsors (2)

Lead Sponsor Collaborator
Biogen Denali Therapeutics Inc.

Countries where clinical trial is conducted

United States,  France,  Germany,  Italy,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to Confirmed Worsening in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II and III Over the Treatment Period Time to confirmed worsening is defined as a worsening event sustained over 2 consecutive assessments. MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part II assesses motor experiences of daily living (range 0-52). It contains 13 questions which are to be completed by the participant. Part III assesses the motor signs of PD and is administered by the rater (range 0-132). Part III contains 33 scores based on 18 items. For each question a numeric score is assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Part II and III combined score equals the sum of Parts II and III (range 0-184). A higher score indicates more severe symptoms of PD. Up to Week 180
Secondary Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose results in death; in the view of the investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect or is a medically important event. AEs: Day 1 up to Week 187; SAEs: Screening up to Week 187
Secondary Time to Confirmed Worsening in MDS-UPDRS Part II Score Over the Treatment Period Time to confirmed worsening is defined as a worsening event sustained over 2 consecutive assessments. MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part II assesses motor experiences of daily living (range 0-52). It contains 13 questions which are to be completed by the participant. For each question a numeric score is assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. A higher score indicates more severe symptoms of PD. Up to Week 180
Secondary Change From Baseline in MDS-UPDRS Parts II and III Combined Score MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part II assesses motor experiences of daily living (range 0-52). It contains 13 questions which are to be completed by the participant. For each question a numeric score is assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. A higher score indicates more severe symptoms of PD. Part III assesses the motor signs of PD and is administered by the rater (range 0-132). Part III contains 33 scores based on 18 items. For each question a numeric score is assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Parts II and III combined score equals the sum of Part II and III (range 0-184). A higher score indicates more severe symptoms of PD. Positive change from baseline indicates severe PD. Baseline up to Week 96
Secondary Time to Confirmed Worsening in Modified Schwab and England Activities of Daily Living Scale (mSE-ADL) Score Over the Treatment Period Time to confirmed worsening is defined as a worsening event sustained over 2 consecutive assessments. The mSE-ADL scale reflects the speed, ease, and independence with which an individual performs daily activities or personal chores with 100% indicating total independence, falling to 0%, which indicates a state of complete dependence. The individual is asked to rate his or her function using an 11-point scale (10% increments), from 100% (completely independent; able to do all chores without slowness, difficulty, or impairment; essentially normal; unaware of any difficulty) to 0% (vegetative functions such as swallowing, bladder and bowels are not functioning; bedridden). The lower the score, the worse the functional status. Up to Week 180
Secondary Change From Baseline in MDS-UPDRS Parts I, II, and III Combined Score MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part I assesses non-motor experiences of daily living and has 2 components (range 0-52). Part IA contains 6 questions and is assessed by the examiner (range 0-24). Part IB contains 7 questions on non-motor experiences of daily living which are to be completed by the participant (range 0-28). Part II assesses motor experiences of daily living (range 0-52). It contains 13 questions which are to be completed by the participant. Part III assesses the motor signs of PD and is administered by the rater (range 0-132). Part III contains 33 scores based on 18 items. For each question a numeric score is assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS total score equals the sum of Parts I, II, and III (range 0-236). A higher score indicates more severe symptoms of PD. Positive change from baseline indicates severe PD. Baseline up to Week 96
See also
  Status Clinical Trial Phase
Completed NCT05415774 - Combined Deep Brain Stimulation in Parkinson's Disease N/A
Recruiting NCT04691661 - Safety, Tolerability, Pharmacokinetics and Efficacy Study of Radotinib in Parkinson's Disease Phase 2
Active, not recruiting NCT05754086 - A Multidimensional Study on Articulation Deficits in Parkinsons Disease
Completed NCT04045925 - Feasibility Study of the Taïso Practice in Parkinson's Disease N/A
Recruiting NCT04194762 - PARK-FIT. Treadmill vs Cycling in Parkinson´s Disease. Definition of the Most Effective Model in Gait Reeducation N/A
Completed NCT02705755 - TD-9855 Phase 2 in Neurogenic Orthostatic Hypotension (nOH) Phase 2
Terminated NCT03052712 - Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies N/A
Recruiting NCT05830253 - Free-living Monitoring of Parkinson's Disease Using Smart Objects
Recruiting NCT03272230 - Assessment of Apathy in a Real-life Situation, With a Video and Sensors-based System N/A
Recruiting NCT06139965 - Validity and Reliability of the Turkish Version of the Comprehensive Coordination Scale in Parkinson's Patients
Completed NCT04580849 - Telerehabilitation Using a Dance Intervention in People With Parkinson's Disease N/A
Completed NCT03980418 - Evaluation of a Semiconductor Camera for the DaTSCAN™ Exam N/A
Completed NCT04477161 - Effect of Ketone Esters in Parkinson's Disease N/A
Completed NCT04942392 - Digital Dance for People With Parkinson's Disease During the COVID-19 Pandemic N/A
Terminated NCT03446833 - LFP Beta aDBS Feasibility Study N/A
Completed NCT03497884 - Individualized Precise Localization of rTMS on Primary Motor Area N/A
Completed NCT05538455 - Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases N/A
Recruiting NCT04997642 - Parkinson's Disease and Movement Disorders Clinical Database
Completed NCT04117737 - A Pilot Study of Virtual Reality and Antigravity Treadmill for Gait Improvement in Parkinson N/A
Recruiting NCT03618901 - Rock Steady Boxing vs. Sensory Attention Focused Exercise N/A