Study Stopped
SPARK did not meet it's primary outcome measure for year 1 and failed to meet secondary outcome measures resulting in the development of BIIB054 (cinpanemab) for Parkinson's disease to be discontinued and SPARK study was closed.
Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Participants With Parkinson's Disease
SPARK
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study, With an Active-Treatment Dose-Blinded Period, to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Subjects With Parkinson's Disease
2 other identifiers
interventional
357
9 countries
75
Brief Summary
The primary objective of the study is to evaluate the clinical efficacy of BIIB054 via dose response using the change from baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score. The secondary objectives of the study are to evaluate the dose-related safety of BIIB054, to evaluate the clinical efficacy of BIIB054 via MDS-UPDRS total score, to assess the pharmacokinetic (PK) profile of BIIB054, to evaluate the clinical efficacy of BIIB054 based on MDS-UPDRS subparts, to evaluate the pharmacodynamic effects of BIIB054 on the integrity of nigrostriatal dopaminergic nerve terminals and to evaluate the immunogenicity of BIIB054.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2018
Typical duration for phase_2
75 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 19, 2017
CompletedFirst Posted
Study publicly available on registry
October 24, 2017
CompletedStudy Start
First participant enrolled
January 10, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 26, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 29, 2021
CompletedResults Posted
Study results publicly available
November 23, 2021
CompletedFebruary 28, 2022
February 1, 2022
2.8 years
October 19, 2017
October 25, 2021
February 15, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change From Baseline in Movement Disorder Society Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score (Sum of Parts I, II, and III) at Week 52
MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part I assessed non-motor experiences of daily living and has 2 components (Range 0-52). Part IA contained 6 questions and were assessed by the examiner (Range 0-24). Part IB contained 7 questions on non-motor experiences of daily living which were completed by the participant (Range 0-28). Part II assessed motor experiences of daily living (Range 0-52). It contained 13 questions completed by the participant. Part III assessed the motor signs of PD and was administered by the rater (Range 0-132). Part III contained 33 scores based on 18 items. For each question a numeric score was 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 indicated more severe symptoms of PD. The mean values reported are the adjusted mean values.
Baseline, Week 52
Change From Baseline in Movement Disorder Society Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score (Sum of Parts I, II, and III) at Week 72
MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part I assessed non-motor experiences of daily living and has 2 components (Range 0-52). Part IA contained 6 questions and were assessed by the examiner (Range 0-24). Part IB contained 7 questions on non-motor experiences of daily living which were completed by the participant (Range 0-28). Part II assessed motor experiences of daily living (Range 0-52). It contained 13 questions completed by the participant. Part III assessed the motor signs of PD and was administered by the rater (Range 0-132). Part III contained 33 scores based on 18 items. For each question a numeric score was 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 indicated more severe symptoms of PD. The mean values reported are the adjusted mean values.
Baseline, Week 72
Secondary Outcomes (13)
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Up to 3 years
Change From Baseline in MDS-UPDRS Total Score (Sum of Parts I, II, and III) at Week 96
Baseline, Week 96
Serum Concentration of BIIB054
Pre-dose and 1 hour post-dose of Baseline, Weeks 4, 8, 12, 16, 24, 32, 36, 44, 52, 60, 68, 84, 96, 120 and 144
Change From Baseline in MDS-UPDRS Subpart I Score at Week 52
Baseline, Week 52
Change From Baseline in MDS-UPDRS Subpart I Score at Weeks 72 and 96
Baseline, Weeks 72 and 96
- +8 more secondary outcomes
Study Arms (4)
Placebo
PLACEBO COMPARATORYear 1: Participants will receive matching placebo to BIIB054 on Day 1 and then every 4 weeks. Year 2: Participants who received placebo in year 1 will be randomized into one of the active treatment arms in year 2 and will receive BIIB054 intravenous (IV) infusion on Week 52 and then every 4 weeks.
BIIB054 250 mg
EXPERIMENTALParticipants will receive BIIB054 250 milligrams (mg) intravenous (IV) infusion on Day 1 and then every 4 weeks.
BIIB054 1250 mg
EXPERIMENTALParticipants will receive BIIB054 1250 mg IV infusion on Day 1 and then every 4 weeks.
BIIB054 3500 mg
EXPERIMENTALParticipants will receive BIIB054 3500 mg IV infusion on Day 1 and then every 4 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosed with Parkinson's disease (PD) within a maximum of 3 years prior to Screening.
- Score of ≤2.5 on the Modified Hoehn and Yahr Scale.
- Has not received any medication for the treatment of the motor symptoms of PD for at least 12 weeks prior to Day 1 and, in the opinion of the Investigator, is not expected to require PD treatment for at least 6 months following Day 1. Maximum total duration of prior PD regimens should not exceed 30 days. Stable (at least 8 weeks) dosages of medications that are used to treat conditions other than PD tremor are allowed. Further guidance will be provided by the study's Medical Monitor on a case by case basis.
- Screening dopamine transporter (DaT)/ single-photon emission computed tomography (SPECT) results consistent with neurodegenerative Parkinsonism (central reading).
- All women of childbearing potential and all men must practice highly effective contraception during the study and for 6 months after their last dose of study treatment.
You may not qualify if:
- Presence of freezing of gait.
- Montreal cognitive assessment (MOCA) score \<23 or other significant cognitive impairment or clinical dementia that, in the opinion of the Investigator, would interfere with study evaluation.
- History of or screening brain magnetic resonance imaging (MRI) scan indicative of clinically significant abnormality, as read by central reader.
- History of severe allergic or anaphylactic reactions, or history of hypersensitivity to BIIB054 or any of the inactive ingredients in the drug product or to radioligands or iodine used in the study.
- Participation in any active immunotherapy study targeting alpha-synuclein.
- Use of allowed medications not previously specified at doses that have not been stable for at least 8 weeks before Day 1, and/or that are not expected to remain stable for the duration of the study.
- Clinically significant abnormal laboratory test values at Screening, as determined by the Investigator.
- Blood donation (1 unit or more) within 8 weeks before Day 1 (must also refrain from donating blood for the duration of the study).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (75)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
St. Joseph's Hopsital & Medical Center- Barrow Neurological Institute
Phoenix, Arizona, 85013, United States
Research Site
La Jolla, California, 92093-0886, United States
Cedars Sinai
Los Angeles, California, 90048, United States
University of California San Francisco Medical Center
San Francisco, California, 94158, United States
Research Site
Stanford, California, 94305, United States
University of Colorado Health
Aurora, Colorado, 80045, United States
Rocky Mountain Movement Disorders Center, PC
Englewood, Colorado, 80113, United States
Parkinson's Disease and Movement Disorders Centerf
Boca Raton, Florida, 33486, United States
Mayo Clinic Hospital
Jacksonville, Florida, 32224, United States
Bioclinica Research
Orlando, Florida, 32806, United States
USF Health Byrd Institute
Tampa, Florida, 33616, United States
Northwestern University PD and Movement Disorders Center
Chicago, Illinois, 60611, United States
Research Site
Chicago, Illinois, 60612, United States
University of Kansas Medical Center Research Institute
Kansas City, Kansas, 66160, United States
Ochsner Health System
New Orleans, Louisiana, 70121, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Boston University Medical Center
Boston, Massachusetts, 02118, United States
Quest Research Institute
Farmington Hills, Michigan, 48334, United States
NYU Langone Health Center
New York, New York, 10017, United States
Research Site
New York, New York, 10032, United States
Research Site
Durham, North Carolina, 27705, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44106, United States
Research Site
Philadelphia, Pennsylvania, 19107, United States
University of Pittsburgh Medical Center Health System
Pittsburgh, Pennsylvania, 15213, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Research Site
Nashville, Tennessee, 37232, United States
Research Site
Houston, Texas, 77030, United States
Booth Gardner Parkinson's Care Center at Evergreen Health
Kirkland, Washington, 98034, United States
Inland Northwest Research
Spokane, Washington, 99204, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Research Site
Innsbruck, 6020, Austria
University Health Network
Toronto, Ontario, M5T 2S8, Canada
Montreal Neurological Institute Clinical Research Unit
Montreal, Quebec, H3A 2B4, Canada
Research Name
Toulouse, Haute Garonne, 31059, France
CHU Nantes - Hopital Nord Laënnec
Nantes, Loire Atlantique, 44093, France
Hopital Roger Salengro - CHU Lille
Lille, Nord, 59037, France
Hôpital Henri Mondor
Créteil, Val De Marne, 94010, France
Research Site
Paris, 75013, France
Universitaetsklinikum Ulm
Ulm, Baden-Wurttemberg, 89081, Germany
Klinikum rechts der Isar der TU Muenchen
Munich, Bavaria, 81675, Germany
Universitaetsklinikum Wuerzburg
Würzburg, Bavaria, 97080, Germany
Paracelsus-Elena-Klinik
Kassel, Hesse, 34128, Germany
Universitaetsklinikum Aachen AOeR
Aachen, North Rhine-Westphalia, 52074, Germany
Research Site
Bochum, North Rhine-Westphalia, 44791, Germany
Research Site
Haifa, 3109601, Israel
Research Site
Tel Aviv, 6423906, Israel
I.R.C.C.S. Neuromed-Istituto Neurologico Mediterraneo
Pozzilli, Isernia, 86077, Italy
Ospedale Bellaria
Bologna, 40139, Italy
Azienda Ospedaliero Univ. Policlinico Gaspare Rodolico
Catania, 95125, Italy
Research Site
Milan, 20122, Italy
Ospedale San Raffaele
Milan, 20132, Italy
Research Site
Milan, 20132, Italy
Seconda Università degli Studi di Napoli
Napoli, 80138, Italy
Research Site
Pisa, 56126, Italy
IRCCS San Raffaele
Roma, 00163, Italy
Azienda Ospedaliera Universitaria OO. RR. S. Giovanni di Dio e Ruggi D'Aragona
Salerno, 84131, Italy
Azienda Ospedaliera Santa Maria di Terni
Terni, 05100, Italy
Hospital General de Catalunya
Sant Cugat Del Vallés, Barcelona, 08190, Spain
Research Site
Móstoles, Madrid, 28938, Spain
Clinica Universidad de Navarra
Pamplona, Navarre, 31008, Spain
Biocruces Health Research Institute
Barakaldo, Vizcaya, 48903, Spain
Hospital Clinic De Barcalona
Barcelona, 08036, Spain
Hospital Santa Creu i Sant Pau
Barcelona, 08041, Spain
Research Site
Madrid, 28006, Spain
Research Site
Madrid, 28007, Spain
Research Site
Madrid, 28034, Spain
Research Site
Seville, 41013, Spain
Research Site
Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom
Salford Royal
Salford, Greater Manchester, M6 8HD, United Kingdom
Research Site
Oxford, Oxfordshire, OX3 9DU, United Kingdom
Clinical Ageing Research Unit
Newcastle upon Tyne, Tyne & Wear, NE4 5PL, United Kingdom
Royal Hallamshire Hospital
Sheffield, West Midlands, S10 2JF, United Kingdom
Research Site
London, WC1N 3BG, United Kingdom
Related Publications (3)
Hutchison RM, Fraser K, Yang M, Fox T, Hirschhorn E, Njingti E, Scott D, Bedell BJ, Kistner KM, Cedarbaum JM, Evans KC, Graham D, Martarello L, Mollenhauer B, Lang AE, Dam T, Beaver J. Cinpanemab in Early Parkinson Disease: Evaluation of Biomarker Results From the Phase 2 SPARK Clinical Trial. Neurology. 2024 Mar 12;102(5):e209137. doi: 10.1212/WNL.0000000000209137. Epub 2024 Feb 5.
PMID: 38315945DERIVEDLang AE, Siderowf AD, Macklin EA, Poewe W, Brooks DJ, Fernandez HH, Rascol O, Giladi N, Stocchi F, Tanner CM, Postuma RB, Simon DK, Tolosa E, Mollenhauer B, Cedarbaum JM, Fraser K, Xiao J, Evans KC, Graham DL, Sapir I, Inra J, Hutchison RM, Yang M, Fox T, Budd Haeberlein S, Dam T; SPARK Investigators. Trial of Cinpanemab in Early Parkinson's Disease. N Engl J Med. 2022 Aug 4;387(5):408-420. doi: 10.1056/NEJMoa2203395.
PMID: 35921450DERIVEDHutchison RM, Evans KC, Fox T, Yang M, Barakos J, Bedell BJ, Cedarbaum JM, Brys M, Siderowf A, Lang AE. Evaluating dopamine transporter imaging as an enrichment biomarker in a phase 2 Parkinson's disease trial. BMC Neurol. 2021 Nov 23;21(1):459. doi: 10.1186/s12883-021-02470-8.
PMID: 34814867DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The study did not meet its primary outcome measure for year 1 and did not demonstrate efficacy on key secondary outcome measures; additional pre-specified analyses at week 72 confirmed the study did not provide evidence of efficacy; resulting in the development of BIIB054 for Parkinson's disease to be discontinued and SPARK study was closed.
Results Point of Contact
- Title
- US Biogen Clinical Trial Center
- Organization
- Biogen
Study Officials
- STUDY DIRECTOR
Medical Director
Biogen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2017
First Posted
October 24, 2017
Study Start
January 10, 2018
Primary Completion
October 26, 2020
Study Completion
April 29, 2021
Last Updated
February 28, 2022
Results First Posted
November 23, 2021
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will share
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/