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History of Changes for Study: NCT03100149
A Study to Evaluate the Efficacy of RO7046015 in Participants With Early Parkinson's Disease (PASADENA)
Latest version (submitted August 29, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 March 29, 2017 None (earliest Version on record)
2 April 24, 2017 Contacts/Locations, Study Status and Oversight
3 June 2, 2017 Recruitment Status, Study Status and Contacts/Locations
4 June 28, 2017 Study Status and Contacts/Locations
5 July 17, 2017 Study Status
6 August 14, 2017 Study Status and Contacts/Locations
7 August 30, 2017 Contacts/Locations and Study Status
8 September 11, 2017 Study Status and Contacts/Locations
9 September 25, 2017 Contacts/Locations and Study Status
10 October 24, 2017 Contacts/Locations and Study Status
11 November 30, 2017 Contacts/Locations and Study Status
12 December 19, 2017 Contacts/Locations and Study Status
13 February 12, 2018 Contacts/Locations, Study Status and References
14 February 19, 2018 Contacts/Locations and Study Status
15 April 3, 2018 Contacts/Locations, Study Status and Eligibility
16 May 30, 2018 Contacts/Locations and Study Status
17 June 21, 2018 Study Status and Contacts/Locations
18 August 14, 2018 Contacts/Locations, Study Status, Eligibility, Arms and Interventions, Study Description and Study Identification
19 August 15, 2018 Arms and Interventions, Study Description, Study Status and Study Identification
20 September 20, 2018 Study Status
21 October 29, 2018 Contacts/Locations and Study Status
22 November 13, 2018 Study Status and Contacts/Locations
23 December 6, 2018 Recruitment Status, Contacts/Locations, Study Status and Study Design
24 December 7, 2018 Recruitment Status, Contacts/Locations, Study Status and Study Design
25 December 14, 2018 Recruitment Status, Study Status, Contacts/Locations and Study Design
26 April 25, 2019 Study Status and Contacts/Locations
27 December 13, 2019 Contacts/Locations, Outcome Measures and Study Status
28 March 19, 2020 Study Status
29 May 21, 2020 Contacts/Locations, Study Status, Arms and Interventions, References, Outcome Measures, Study Description and Study Identification
30 July 3, 2020 Study Status and Contacts/Locations
31 September 28, 2020 Study Status
32 November 26, 2020
Quality Control Review has not concluded Returned: December 21, 2020
Outcome Measures, Study Status, Document Section
33 January 14, 2021 Outcome Measures, Study Status, Participant Flow, Adverse Events and Baseline Characteristics
34 February 24, 2021 Outcome Measures and Study Status
35 March 31, 2021 Study Status and Contacts/Locations
36 June 24, 2021 Study Status and Contacts/Locations
37 September 23, 2021 Arms and Interventions, Study Status, IPDSharing, Eligibility and Study Description
38 December 16, 2021 Study Status and Contacts/Locations
39 March 7, 2022 Study Status and Contacts/Locations
40 June 1, 2022 Study Status
41 August 29, 2022 Study Status
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Study NCT03100149
Submitted Date:  March 29, 2017 (v1)

Open or close this module Study Identification
Unique Protocol ID: BP39529
Brief Title: A Study to Evaluate the Efficacy of RO7046015 in Participants With Early Parkinson's Disease (PASADENA)
Official Title: A Randomized, Double-Blind, Placebo-Controlled, 52-Week Phase II Study to Evaluate the Efficacy of Intravenous RO7046015 (PRX002) in Participants With Early Parkinson's Disease With a 52-Week Blinded Extension
Secondary IDs: 2017-000087-15 [EudraCT Number]
Open or close this module Study Status
Record Verification: March 2017
Overall Status: Not yet recruiting
Study Start: May 31, 2017
Primary Completion: July 30, 2019 [Anticipated]
Study Completion: October 20, 2020 [Anticipated]
First Submitted: March 29, 2017
First Submitted that
Met QC Criteria:
March 29, 2017
First Posted: April 4, 2017 [Actual]
Last Update Submitted that
Met QC Criteria:
March 29, 2017
Last Update Posted: April 4, 2017 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Hoffmann-La Roche
Responsible Party: Sponsor
Collaborators: Prothena Biosciences Limited
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring:
Open or close this module Study Description
Brief Summary: This multicenter, randomized, double-blind, placebo-controlled, Phase 2 study will evaluate the efficacy of intravenous RO7046015 versus placebo over 52 weeks in participants with early Parkinson's Disease (PD) who are untreated or treated with monoamine oxidase B (MAO-B) inhibitors since baseline. The study will consist of 2 parts: a 52-week, double-blind, placebo-controlled treatment period (Part 1) after which eligible participants will continue into an all-participants-on-treatment blinded dose extension for an additional 52 weeks (Part 2).
Detailed Description:
Open or close this module Conditions
Conditions: Parkinson's Disease
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 5
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 300 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Part 1: RO7046015 High Dose
Participants will receive RO7046015 at high dose level as intravenous infusion every 4 weeks (Q4W) up to 52 weeks in Part 1.
Drug: RO7046015
RO7046015 will be administered at dose of 4500 milligrams (mg) for participants with body-weight greater than or equal to (>/=) 65 kilograms (kg) or 3500 mg for participants with body-weight less than (<) 65 kg.
Other Names:
  • PRX002
Experimental: Part 1: RO7046015 Low Dose
Participants will receive RO7046015 at low dose level as intravenous infusion Q4W up to 52 weeks in Part 1.
Drug: RO7046015
RO7046015 will be administered at dose of 1500 mg to all participants in the indicated arm.
Other Names:
  • PRX002
Placebo Comparator: Part1: Placebo
Participants will receive placebo as intravenous infusion Q4W up to 52 weeks in Part 1.
Drug: Placebo
RO7046015 placebo will be administered to all participants in the indicated arm.
Experimental: Part 2: RO7046015 High Dose
Part 1 RO7046015 high dose group participants and placebo group participants randomized to high dose level will receive RO7046015 at high dose level as intravenous infusion Q4W for additional 52 weeks in Part 2.
Drug: RO7046015
RO7046015 will be administered at dose of 4500 milligrams (mg) for participants with body-weight greater than or equal to (>/=) 65 kilograms (kg) or 3500 mg for participants with body-weight less than (<) 65 kg.
Other Names:
  • PRX002
Experimental: Part 2: RO7046015 Low Dose
Part 1 RO7046015 low dose group participants and placebo group participants randomized to low dose level will receive RO7046015 at low dose level as intravenous infusion Q4W for additional 52 weeks in Part 2.
Drug: RO7046015
RO7046015 will be administered at dose of 1500 mg to all participants in the indicated arm.
Other Names:
  • PRX002
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Change From Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score (Sum of Parts I, II, and III) at Week 52
[ Time Frame: Baseline and Week 52 ]

Secondary Outcome Measures:
1. Change From Baseline in Dopamine Transporter Imaging With Single Photon Emission Computed Tomography (DaT-SPECT) Signal at Week 52
[ Time Frame: Baseline and Week 52 ]

2. Change From Baseline in the MDS-UPDRS Motor Subscale (Part III) Score
[ Time Frame: Baseline and Week 52 ]

3. Clinical Global Impression of Improvement (CGI-I) Score at Weeks 24 and 52
[ Time Frame: Week 24 and Week 52 ]

4. Patient Global Impression of Change (PGIC) Score at Weeks 24 and 52
[ Time Frame: Week 24 and Week 52 ]

5. Time to Start of Dopaminergic Symptomatic Treatment
[ Time Frame: From Baseline to Week 52 ]

6. Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
[ Time Frame: From Day 1 to Week 104 ]

7. Percentage of Participants With Anti-Drug Antibodies (ADAs) Against RO7046015
[ Time Frame: Baseline, Pre-dose (0 hours) on Weeks 4, 20, 36, 52, 56, 68, 80, and 104; at early termination (up to Week 104), and follow-up (12 weeks after last dose up to Week 116) ]

8. Systemic Clearance (CL) of RO7046015
[ Time Frame: Predose (0 hours) and end of infusion (infusion length=2 hours or less) on Day 1, Weeks 4, 20, 36, 52, 56, 68, 80, and 104; at Day 7, Day 14, early termination (up to Week 104), and follow-up (12 weeks after last dose up to Week 116) ]

9. Apparent Volume of Distribution (Vz/F) of RO7046015
[ Time Frame: Predose (0 hours) and end of infusion (infusion length=2 hours or less) on Day 1, Weeks 4, 20, 36, 52, 56, 68, 80, and 104; at Day 7, Day 14, early termination (up to Week 104), and follow-up (12 weeks after last dose up to Week 116) ]

10. Area Under the Serum Concentration-Time Curve (AUC) of RO7046015
[ Time Frame: Predose (0 hours) and end of infusion (infusion length=2 hours or less) on Day 1, Weeks 4, 20, 36, 52, 56, 68, 80, and 104; at Day 7, Day 14, early termination (up to Week 104), and follow-up (12 weeks after last dose up to Week 116) ]

11. Maximum Observed Serum Concentration (Cmax) of RO7046015
[ Time Frame: Predose (0 hours) and end of infusion (infusion length=2 hours or less) on Day 1, Weeks 4, 20, 36, 52, 56, 68, 80, and 104; at Day 7, Day 14, early termination (up to Week 104), and follow-up (12 weeks after last dose up to Week 116) ]

12. Minimum Observed Serum Trough Concentration (Ctrough) of RO7046015
[ Time Frame: Predose (0 hours) and end of infusion (infusion length=2 hours or less) on Day 1, Weeks 4, 20, 36, 52, 56, 68, 80, and 104; at Day 7, Day 14, early termination (up to Week 104), and follow-up (12 weeks after last dose up to Week 116) ]

Open or close this module Eligibility
Minimum Age: 40 Years
Maximum Age: 80 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Idiopathic PD with bradykinesia plus one of the other cardinal signs of PD (resting tremor, rigidity) being present, without any other known or suspected cause of PD untreated or treated with MAO-B inhibitor
  • Body weight range between: >/=45 kg/ 99 pounds (lbs) and less than or equal to (</=) 110 kg/242 lbs
  • Body mass index (BMI) of 18 to 34 kilograms per meter-squared (kg/m^2)
  • A diagnosis of PD for 2 years or less at screening
  • Hoehn and Yahr Stage I or II
  • A screening brain DaT-SPECT consistent with PD (central reading)
  • Clinical status does not require dopaminergic PD medication and is not expected to require dopaminergic treatment within 52 weeks from baseline
  • If presently being treated for PD, a stable dose of MAO-B inhibitor (rasagiline or selegiline) for at least 90 days prior to baseline and not expected to change within 52 weeks
  • For women of childbearing potential: use of highly effective contraceptive methods (that result in a failure rate of <1 percent [%] per year) during the treatment period and for at least 30 days (or longer if required by local regulations) after the last dose of study drug
  • For men with female partners of childbearing potential or pregnant female partners, must use a condom during the treatment period and for at least 30 days (or longer if required by local regulations) after the last dose of study drug to avoid exposing the embryo. Men must refrain from donating sperm during this same period. The female partners should use a contraception method with a failure rate of <1% per year during the treatment period and for at least 30 days (or longer if required by local regulations) after the last dose of study drug

Exclusion Criteria:

  • Clinical signs or past medical history indicating a Parkinson syndrome other than idiopathic PD, including but not limited to, progressive supranuclear gaze palsy, multiple system atrophy, drug-induced parkinsonism, essential tremor, primary dystonia
  • Known carriers of certain familial PD genes (as specified in study protocol)
  • History of PD related freezing episodes or falls
  • A diagnosis of a significant CNS disease other than Parkinson's disease; history of repeated head injury; history of epilepsy or seizure disorder other than febrile seizures as a child
  • Mini Mental State Examination (MMSE) </=25
  • Reside in a nursing home or assisted care facility
  • History of or screening brain magnetic resonance imaging (MRI) scan indicative of clinically significant abnormality
  • Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the participant in this study or interfere with the participant's ability to comply with study procedures or abide by study restrictions, or with the ability to interpret safety data
  • Any significant cardiovascular condition
  • Any significant laboratory abnormality
  • Lactating women
  • Prior treatment with dopaminergic medication (for example, levodopa or a dopaminergic agonist) with no clinical treatment response or a clinical treatment response inconsistent with PD
  • Use of any of the following: catechol-O-methyl transferase (COMT) inhibitors (entacapone, tolcapone), amantadine or anticholinergics, or dopaminergic medication (levodopa and both ergot and non-ergot [pramipexole, ropinirole, rotigotine] dopamine agonists) for more than a total of 60 days or within 60 days of baseline
  • Anti-epileptic medication for non-seizure-related treatment which has not remained stable for at least 60 days prior to baseline
  • Anti-depressant or anxiolytic use that has not remained stable for at least 90 days prior to baseline
  • Use of any of the following within 90 days prior to baseline: neuroleptics, metoclopramide, alpha methyldopa, clozapine, olanzapine, flunarizine, amoxapine, amphetamine derivatives, reserpine, bupropion, buspirone, cocaine, mazindol, methamphetamine, methylphenidate, norephedrine, phentermine, phenylpropanolamine, and modafinil
  • Participated in an investigational drug or device study including prior treatment of PD involving intracranial surgery or implantation of a device
  • Any prior treatment with an investigational PD-related vaccine
  • Prior participation in any RO7046015 or PRX002 study
  • Receipt of an investigational product or device, or participation in a drug research study within a period of 30 days (or 5 half-lives of the drug, whichever is longer) before baseline
  • Receipt of a monoclonal antibody or an investigational immunomodulator within 180 days (or 5 half-lives, whichever is longer) before baseline
  • Systemic corticosteroids or other immunomodulating drugs within 30 days prior to baseline
  • Allergy to any of the components of RO7046015 or a known hypersensitivity or an Infusion-related reaction (IRR) to the administration of any other monoclonal antibody
  • Any contraindications to obtaining a brain MRI
  • For participants consenting to provide optional cerebrospinal fluid (CSF) samples by lumbar puncture (LP): LP will only be performed if the participant does not have any contraindication to undergoing an LP
  • Donation of blood over 500 milliliters (mL) within three months prior to screening
Open or close this module Contacts/Locations
Central Contact Person: Reference Study ID Number: BP39529 www.roche.com/about_roche/roche_worldwide.htm
Telephone: 888-662-6728 (U.S.)
Email: global-roche-genentech-trials@gene.com
Central Contact Backup: Global Medical Information:
Email: global.medical_information@roche.com
Locations: United States, Alabama
Uab Medicine
South Birmingham, Alabama, United States, 35233
United States, Arizona
Barrow Neurology Clinics; Movement Disorders Program
Phoenix, Arizona, United States, 85013
United States, California
USC Keck Medical Center of USC
Los Angeles, California, United States, 90033
University of California at San Francisco
San Francisco, California, United States, 94115
United States, Connecticut
Molecular Neurolmaging
New Haven, Connecticut, United States, 06510
United States, Florida
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, United States, 33486
Compass Research East, LLC
Orlando, Florida, United States, 32806
Johnnie B. Byrd Sr. Alzheimer's Center & Research Institute
Tampa, Florida, United States, 33613
United States, Illinois
Northwestern University
Evanston, Illinois, United States, 60208
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 20742
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Michigan
Quest Research Institute
Farmington Hills, Michigan, United States, 48334
Spectrum Health Medical Group
Grand Rapids, Michigan, United States, 49508
Henry Ford Health System
West Bloomfield, Michigan, United States, 48322
United States, New York
Columbia University
New York, New York, United States, 10032
University of Rochester Medical Center
Rochester, New York, United States, 14618
United States, Oregon
Oregon Health & Science Uni
Portland, Oregon, United States, 97239
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
Baylor College
Houston, Texas, United States, 77030
United States, Vermont
University of Vermont Medical Center
Burlington, Vermont, United States, 05401
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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