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PADOVA: A Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants With Early Parkinson's Disease

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04777331
Collaborator
Prothena Biosciences Limited (Industry)
575
Enrollment
126
Locations
2
Arms
64.5
Anticipated Duration (Months)
4.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a multicenter, randomized, double-blind, placebo-controlled study that will evaluate the efficacy and safety of intravenous (IV) prasinezumab versus placebo in participants with Early Parkinson's Disease (PD) who are on stable symptomatic PD medication.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
575 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase IIB, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants With Early Parkinson's Disease
Actual Study Start Date :
May 5, 2021
Anticipated Primary Completion Date :
Jun 12, 2024
Anticipated Study Completion Date :
Sep 18, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Prasinezumab

Participants will receive an IV infusion of prasinezumab every 4 weeks (Q4W). Participants will enter into the optional Open Label Extension (OLE) once the double-blind treatment period has completed.

Drug: Prasinezumab
Prasinezumab will be administered as an IV infusion to participants Q4W.
Placebo Comparator: Placebo

Participants will receive placebo as an IV infusion Q4W.

Drug: Placebo
Prasinezumab placebo will be administered to participants.

Outcome Measures

Primary Outcome Measures

  1. Time to Meaningful Progression on Motor Signs of the Disease, as Assessed by >= 5 Points Increase in Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score from Baseline [From baseline until 28 days after final dose of study treatment]

  2. OLE: Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) [From baseline until 70 days after final dose of study treatment]

  3. OLE: Number of Participants with Adverse Events of Special Interest (AESI) [From baseline until 70 days after final dose of study treatment]

  4. OLE: Number of Participants with Infusion Related Reactions (IRRs) [From baseline until 70 days after final dose of study treatment]

  5. OLE: Change from Baseline in Suicidal Ideation, as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS) [From baseline until 70 days after final dose of study treatment]

Secondary Outcome Measures

  1. Time-to-worsening of Participants Motor Function as Reported by the Participant in MDS-UPDRS Part II and Confirmed by the Clinician in MDS-UPDRS Part III [From baseline until 28 days after final dose of study treatment]

  2. Time to Meaningful Worsening in Patient Global Impression of Change (PGI-C, Overall Disease Subscale) [From baseline until 28 days after final dose of study treatment]

  3. Time to Meanaingful Worsening in Clinician Global Impression of Change (CGI-C, Overall Disease Subscale) [From baseline until 28 days after final dose of study treatment]

  4. Change in Motor Function from Baseline to Week 76, as Measured by the MDS-UPDRS Part III Total Score [From baseline to Week 76]

  5. Change in Bradykinesia from Baseline to Week 76, as Measured by the MDS-UPDRS Part III Bradykinesia Subscore [From baseline to Week 76]

  6. Change in Motor Aspects of Experiences of Daily Living from Baseline to Week 76, as Measured by MDS-UPDRS Part II [From baseline to Week 76]

  7. Percentage of Participants With AEs and SAEs [From baseline until 70 days after final dose of study treatment]

  8. Number of Participants with AESI [From baseline until 70 days after final dose of study treatment]

  9. Number of Participants with IRRs [From baseline until 70 days after final dose of study treatment]

  10. Change from Baseline in Suicidal Ideation, as Measured by the C-SSRS [From baseline until 28 days after final dose of study treatment]

  11. Serum Concentration of Prasinezumab [From weeks 1, 2, 4, 8, 12, 24, 36, 52, 64, 76 and after week 76 every 12 weeks therafter until end of study (approximately 28 days after the final dose)]

  12. Percentage of Participants with Anti-drug Antibodies (ADAs) Against Prasinezumab at Baseline [At Baseline]

  13. Percentage of Participants with ADAs Against Prasinezumab During the Study [Up to end of study visit (approximately 76 weeks)]

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Diagnosis of idiopathic PD based on MDS criteria with bradykinesia plus one of the other cardinal signs of PD (resting tremor, rigidity), without any other known or suspected cause of parkinsonism

  • On symptomatic PD medication, with stable doses for at least 3 months prior to baseline

  • A diagnosis of PD for at least 3 months to maximum 3 years at screening

  • MDS-UPDRS Part IV score of 0 at screening and prior to randomization

  • Hoehn and Yahr (H&Y) Stage I or II in OFF medication state at screening and prior to randomization

  • Dopamine transporter imaging with single photon emission computed tomography (DaT-SPECT) imaging consistent with dopamine transporter deficit, as assessed by the central reader

  • No anticipated changes in PD medication from baseline throughout the study duration based on clinical status during screening

  • Willingness and ability to use a smartphone application to measure PD-related symptoms for the duration of the study

  • Willingness and ability to wear a smartwatch to measure PD-related motor signs

Exclusion Criteria:

  • Medical history indicating a Parkinsonian syndrome other than idiopathic PD

  • Diagnosis of PD dementia

  • Diagnosis of a significant neurologic disease other than PD

  • Within the last year, unstable or clinically significant cardiovascular disease

  • Uncontrolled hypertension

  • Drug and/or alcohol abuse within 12 months prior to screening, in the investigator's judgment (Nicotine is allowed, Marijuana use is not allowed)

  • Clinically significant abnormalities in laboratory test results at the screening visit, including hepatic and renal panels, complete blood count, chemistry panel and urinalysis

  • Allergy to any of the components of prasinezumab, a known hypersensitivity, or a previous IRR following administration of any other monoclonal antibody

  • Any contraindications to obtaining a brain magnetic resonance imaging (MRI)

  • Any contraindications to DaT-SPECT imaging

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Alabama at Birmingham Birmingham Alabama United States 35294
2 Barrow Neurological Institute Phoenix Arizona United States 85013
3 Banner Sun Health Research Insitute Sun City Arizona United States 85351
4 Neurology Center of North Orange County Fullerton California United States 92835
5 Collaborative Neuroscience Network, Inc. Garden Grove California United States 92845
6 UC San Diego; ACTRI La Jolla California United States 92037
7 Keck School of Medicine of USC Los Angeles California United States 900033
8 Cedars Sinai Medical Center Los Angeles California United States 90048
9 University of California San Francisco San Francisco California United States 94117
10 CenExel Rocky Mountain Clinical Research, LLC Englewood Colorado United States 80113
11 Institute for Neurodegenerative Disorders New Haven Connecticut United States 06510
12 JEM Research LLC Atlantis Florida United States 33462
13 Aventura Neurologic Associates; Department of Research Aventura Florida United States 33180
14 Parkinson's Disease and Movement Disorders Center of Boca Raton Boca Raton Florida United States 33486
15 ClinCloud, LLC Maitland Florida United States 32751
16 Neurology Associates, PA; Research Department Maitland Florida United States 32751
17 Renstar Medical Research Ocala Florida United States 34470
18 Synexus Clinical Research Orlando Florida United States 32806
19 University of South Florida Tampa Florida United States 33613-4706
20 Conquest Research, LLC Winter Park Florida United States 32789
21 Charter Research - Winter Park/Orlando Winter Park Florida United States 32792
22 Northwestern University Feinberg School Of Medicine Chicago Illinois United States 60611
23 Southern Illinois University, School of Medicine Springfield Illinois United States 62702
24 Indiana University Health University Hospital Indianapolis Indiana United States 46202
25 University of Kansas Medical Center Kansas City Kansas United States 66160
26 Massachusetts General Hospital Boston Massachusetts United States 02114-2759
27 Quest Research Institute Farmington Hills Michigan United States 48334
28 Henry Ford Hospital; Henry Ford Medical Center West Bloomfield Michigan United States 48322
29 Meridian Clinical Research, Llc Omaha Nebraska United States 68134
30 The Cognitive and Research Center of New Jersey Springfield New Jersey United States 07081
31 Neroscience research institute Toms River New Jersey United States 08755
32 Dent Neurological Institute Amherst New York United States 14226
33 Neuroscience Institute at Great Neck New York New York United States 11021
34 Cleveland Clinic Cleveland Ohio United States 44195
35 The Movement Disorder Clinic of Oklahoma Tulsa Oklahoma United States 74136
36 University Pennsylvania Hospital Philadelphia Pennsylvania United States 19104
37 Abington Neurological Associates Willow Grove Willow Grove Pennsylvania United States 19090
38 Texas Neurology PA Dallas Texas United States 75206
39 Baylor College of Medicine Medical Center Houston Texas United States 77030
40 Central Texas Neurology Consultants Round Rock Texas United States 78681
41 University of Vermont Medical Center Burlington Vermont United States 05401
42 Sentara Neurology Specialists Norfolk Virginia United States 23507
43 Evergreen Health Care Center Kirkland Washington United States 98034
44 Inland Northwest Research Spokane Washington United States 99202
45 Medizinische Universität Graz; Universitätsklinik für Neurologie Graz Austria 8036
46 Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck; Department fuer Neurologie Innsbruck Austria 6020
47 Klinik Ottakring; Neurologische Abteilung Wien Austria 1160
48 Toronto Memory Program Toronto Ontario Canada M3B 2S7
49 Clinique Neuro Outaouais Gatineau Quebec Canada J8Y 1W2
50 Montreal Neurological Institute and Hospital Montreal Quebec Canada H3A 2B4
51 Groupe Hospitalier Pellegrin Bordeaux France 33000
52 Groupement Hospitalier Est - Hôpital Neurologique; Neurologie A (U502) Bron cedex France 69677
53 Hopital Gabriel Montpied Clermont-ferrand France 63003
54 Hôpital Henri Mondor; Centre Expert Parkinson Creteil France 94000
55 Hôpital Michallon - Centre d'Investigation Clinique; Unité de Pharmacologie Clinique - Inserm Grenoble France 38043
56 CHU de Limoges - Hôpital Dupuytren Limoges France 87042
57 hopital de la Timone Marseille France 13385
58 CHU Gui de Chauliac Montpellier France 34000
59 CHU de Nice Hopital Pasteur Nice France 06002
60 Hopital Pitie-Salpetriere APHP Paris France 75013
61 CHU Poitiers Poitiers France 86021
62 CHU Rouen Charles Nicolle; Centre Expert Parkinson Hôpitaux de Rouen Rouen cedex France 76031
63 CHU de Nantes - Hopital Laennec St Herblain France 44800
64 CHU Strasbourg - Hôpital Hautepierre Strasbourg France 67098
65 CIC - Hôpital Purpan Toulouse France 31059
66 Università degli studi della Campania Luigi Vanvitelli; Dip.Ass Int Med Int-I Clinica Neurologica Napoli Campania Italy 80138
67 Az. Osp. OO.RR. S. Giovanni di Dio e Ruggi D' Aragona; Center for Neurodegenerative Disease Salerno Campania Italy 84131
68 Ospedale Bellaria; Istituto delle Scienze Neurologiche Bologna Emilia-Romagna Italy 40139
69 IRCCS San Raffaele Pisana; Clinical Trial Center Roma Lazio Italy 00163
70 Policlinico Universitario Agostino Gemelli; UOC Neurologia Roma Lazio Italy 00168
71 Irccs A.O.U.San Martino Ist; Dinogmi Genova Liguria Italy 16132
72 Azienda Ospedaliera Spedali Civili; Scienze Neurologiche Brescia Lombardia Italy 25100
73 IRCCS Ospedale San Raffaele; U.O. di Neurologia Milano Lombardia Italy 20132
74 IRCCS Istituto Neurologico Carlo Besta; UOC Neurologia 1 Milano Lombardia Italy 20133
75 IRCCS Neuromed; Neurologia I Pozzilli (IS) Molise Italy 86077
76 A.O.U. Policlinico "G.Rodolico - San Marco"; Clinica Neurologica Catania Sicilia Italy 95123
77 A.O. Universitaria Pisana; Neurologia Pisa Toscana Italy 56126
78 AO di Perugia - Ospedale S. Maria della Misericordia; Clinica Neurologica Perugia Umbria Italy 06156
79 Azienda Ospedaliera S. Maria; SC Neurologia Terni Umbria Italy 05100
80 Azienda Ospedaliera di Padova; Dipartimento di Neuroscienze Padova Veneto Italy 35128
81 Centre Hospitalier de Luxembourg Luxembourg Luxembourg 1210
82 NZOZ Vitamed Bydgoszcz Poland 85-079
83 Szpital Sw. Wojciecha; Oddzial Neurologiczny Gdańsk Poland 80-462
84 Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii K Krakow Poland 31-505
85 Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak. Lublin Poland 20-016
86 Nzoz Palomed Rzeszów Poland 35-232
87 Samodzielny Publiczny Szpital Kliniczny im. prof. Orlowskiego; Klinika Neurologii i Epileptologii Warszawa Poland 00-416
88 Centrum Medyczne NeuroProtect Warszawa Poland 01-684
89 Mazowiecki Szpital Bródnowski w Warszawie Sp. z o.o.; Klinika Neurologii Warszawa Poland 03-242
90 NeuroKlinika Gabinet Lekarski Prof. Andrzej Bogucki Łódź Poland 90-640
91 Hospital General Universitario de Elche; Servicio de Neurología Elche Alicante Spain 03203
92 Hospital General De Catalunya; Servicio de Neurologia Sant Cugat del Valles Barcelona Spain 8195
93 Policlínica Guipuzkoa; Servicio de Neurología Donosti-San Sebastián Guipuzcoa Spain 20014
94 Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Neurologia Coruña LA Coruña Spain 15006
95 Hospital San Pedro; Servicio de Neurología Logroño LA Rioja Spain 26006
96 Hospital San Roque Mas Palomas LAS Palmas Spain 35100
97 Hospital Universitario Fundación Alcorcón; Servicio de Neurología Alcorcon Madrid Spain 28922
98 HM Universitario Puerta del Sur CINAC (C.Integ.Neuroc);; Servicio de Psiquiatría Móstoles Madrid Spain 28938
99 Hospital Quiron de Madrid; Servicio de Neurologia Pozuelo de Alarcon Madrid Spain 28223
100 Clinica Universidad de Navarra Pamplona Navarra Spain 31008
101 Hospital Virgen del Puerto Plasencia Palencia Spain 10600
102 Hospital de Cruces; Servicio de Neurologia Barakaldo Vizcaya Spain 48903
103 Hospital Vall d'Hebron; Servicio de Neurología Barcelona Spain 08035
104 Hospital Clinic Servicio de Neurologia Barcelona Spain 08036
105 Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia Barcelona Spain 08041
106 Hospital Universitario de Burgos. Servicio de Neurología Burgos Spain 09006
107 Hospital General Universitario de Ciudad Real; Servicio de Neurologia Ciudad Real Spain 13071
108 Hospital Ruber Juan Bravo Madrid Spain 28006
109 Hospital Universitario de la Princesa; Servicio de Neurologia Madrid Spain 28006
110 Hospital General Universitario Gregorio Marañon; Servicio de Neurologia Madrid Spain 28007
111 Hospital Universitario Clínico San Carlos; Servicio de Neurología Madrid Spain 28040
112 Hospital Universitario 12 de Octubre; Servicio de Neurologia Madrid Spain 28041
113 Hospital Regional Universitario Carlos Haya; Servicio de Neurologia Malaga Spain 29010
114 Hospital Universitario Virgen Macarena; Servicio de Neurologia Sevilla Spain 41009
115 Hospital Virgen del Rocío; Servicio de Neurología Sevilla Spain 41013
116 Hospital Universitario Dr. Peset; Servicio de Neurologia Valencia Spain 46017
117 Hospital Universitari i Politecnic La Fe; Servicio de Neurología Valencia Spain 46026
118 Servicio de Neurología Hospital Viamed Montecanal. Zaragoza Spain 50012
119 Ninewells Hospital, Dundee- Scotland; Neurology Dundee United Kingdom DD2 1SY
120 Kings College Hospital London United Kingdom SW9 8RR
121 Charing Cross Hospital London United Kingdom W6 8RF
122 Campus for Ageing and Vitality Newcastle United Kingdom NE4 5PL
123 Oxford University Hospitals NHS Foundation Trust Oxford United Kingdom OX3 7LE
124 North West Anglia NHS Foundation Trust Peterborough United Kingdom PE3 9GZ
125 Derriford Hospital Plymouth United Kingdom PL6 8DH
126 Lancashire Teaching Hospitals NHS Foundation Trust Preston United Kingdom PR5 6YA

Sponsors and Collaborators

  • Hoffmann-La Roche
  • Prothena Biosciences Limited

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT04777331
Other Study ID Numbers:
  • BN42358
  • 2020-004997-23
First Posted:
Mar 2, 2021
Last Update Posted:
Aug 18, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Parkinson Disease

Study Results

No Results Posted as of Aug 18, 2022