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A Study to Evaluate the Efficacy of RO7046015 in Participants With Early Parkinson's Disease (PASADENA)

This study is currently recruiting participants.
Verified November 2017 by Hoffmann-La Roche
Sponsor:
ClinicalTrials.gov Identifier:
NCT03100149
First Posted: April 4, 2017
Last Update Posted: December 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Prothena Biosciences Limited
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
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).

Condition Intervention Phase
Parkinson's Disease Drug: RO7046015 Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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:
  • 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 ]
  • Change From Baseline in the MDS-UPDRS Motor Subscale (Part III) Score [ Time Frame: Baseline and Week 52 ]
  • Clinical Global Impression of Improvement (CGI-I) Score at Weeks 24 and 52 [ Time Frame: Week 24 and Week 52 ]
  • Patient Global Impression of Change (PGIC) Score at Weeks 24 and 52 [ Time Frame: Week 24 and Week 52 ]
  • Time to Start of Dopaminergic Symptomatic Treatment [ Time Frame: From Baseline to Week 52 ]
  • Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) [ Time Frame: From Day 1 to Week 104 ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]

Estimated Enrollment: 300
Actual Study Start Date: June 27, 2017
Estimated Study Completion Date: June 29, 2021
Estimated Primary Completion Date: March 31, 2020 (Final data collection date for primary outcome measure)
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 Name: 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 Name: 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 Name: 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 Name: PRX002

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03100149


Contacts
Contact: Reference Study ID Number: BP39529 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S.) global-roche-genentech-trials@gene.com
Contact: Global Medical Information: global.medical_information@roche.com

  Show 47 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Prothena Biosciences Limited
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03100149     History of Changes
Other Study ID Numbers: BP39529
2017-000087-15 ( EudraCT Number )
First Submitted: March 29, 2017
First Posted: April 4, 2017
Last Update Posted: December 1, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases