Parkinson's DiseasePhase 1NCT02157714
Multiple Ascending Dose Study of PRX002 in Patients With Parkinson's Disease
A Phase 1 study testing PRX002 in people with Parkinson's Disease, run by Prothena Biosciences Limited at 8 sites in United States.
Trial summary
This multiple ascending dose study is to determine safety, tolerability, pharmacokinetics and immunogenicity of PRX002 in approximately 60 patients with Parkinson's disease. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- PRX002
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 8 sitesUnited States
- Study dates
- Jun 2014to Sep 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Idiopathic Parkinson's disease, Hoehn and Yahr 1-3
- Body weight range of ≥ 45kg/99 lbs to ≤ 110 kg/242 lbs
- Female subjects must be surgically sterile or post-menopausal or if of child-bearing potential must use contraception
- Male subjects and their partners of childbearing potential must use contraception
Who cannot join
- Significant cardiac history
- Abnormal MRI
- Significant laboratory abnormalities
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
QUEST Research Institute
Bingham Farms, Michigan, 48025
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, 33486
MD Clinical
Hallandale, Florida, 33009
Baylor College of Medicine
Houston, Texas, 77030
Collaborative Neuroscience Network, LLC
Long Beach, California, 90806
Institute for Neurodegenerative Disorders
New Haven, Connecticut, 06510
Compass Research, LLC
Orlando, Florida, 32806
Oregon Health and Science University, Department of Neurology
Portland, Oregon, 97239
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of PRX002 Administered By Intravenous Infusion in Patients With Parkinson's Disease
This multiple ascending dose study is to determine safety, tolerability, pharmacokinetics and immunogenicity of PRX002 in approximately 60 patients with Parkinson's disease.
- Conditions
- Parkinson's Disease
- Being tested
- PRX002, Placebo
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRX002Drug
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| PRX002 | Experimental | PRX002 Receives: Drug: PRX002 |
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability as determined by number of subjects with adverse events
Measured: up to 6 months
Determination of pharmacokinetics parameters
maximum concentration (Cmax)
Measured: up to 6 months
Determination of pharmacokinetics parameters
time of the maximum measured concentration (Tmax)
Measured: up to 6 months
Determination of pharmacokinetics parameters
area under the concentration-time curve from time zero to the last quantifiable concentration time-point (AUClast)
Measured: up to 6 months
Determination of pharmacokinetics parameters
area under the concentration-time curve from time zero extrapolated to infinity (AUCinf)
Measured: up to 6 months
Determination of pharmacokinetics parameters
elimination rate constant
Measured: up to 6 months
Determination of pharmacokinetics parameters
terminal elimination half life (t½)
Measured: up to 6 months
Determination of pharmacokinetics parameters
clearance (CL)
Measured: up to 6 months
Determination of pharmacokinetics parameters
apparent volume of distribution (Vd)
Measured: up to 6 months
Determination of pharmacokinetics parameters
average concentration over a dosing interval (Cav)
Measured: up to 6 months
Determination of pharmacokinetics parameters
area under the plasma concentration-time curve for a dosing interval (AUCtau)
Measured: up to 6 months
Determination of pharmacokinetics parameters
minimum observed concentration (Cmin)
Measured: up to 6 months
Secondary outcomes (1)
Immunogenicity as determined by measurement of anti-PRX002 antibodies
Multiple clinical and exploratory biomarkers will be assessed
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prothena Biosciences Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hoffmann-La Roche
- Responsible party
- Sponsor
- Investigators
- Jay Soto, Study director, Clinical Trials Prothena Biosciences Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02157714
- Sponsor's protocol ID
- PRX002-CL002
- Status last verified
- Oct 2016
- First submitted
- 4 Jun 2014
- Last updated
- 21 Oct 2016
- Results posted
- No
Publications
Jankovic J, Goodman I, Safirstein B, Marmon TK, Schenk DB, Koller M, Zago W, Ness DK, Griffith SG, Grundman M, Soto J, Ostrowitzki S, Boess FG, Martin-Facklam M, Quinn JF, Isaacson SH, Omidvar O, Ellenbogen A, Kinney GG. Safety and Tolerability of Multiple Ascending Doses of PRX002/RG7935, an Anti-alpha-Synuclein Monoclonal Antibody, in Patients With Parkinson Disease: A Randomized Clinical Trial. JAMA Neurol. 2018 Oct 1;75(10):1206-1214. doi: 10.1001/jamaneurol.2018.1487.
PubMed 29913017Schenk DB, Koller M, Ness DK, Griffith SG, Grundman M, Zago W, Soto J, Atiee G, Ostrowitzki S, Kinney GG. First-in-human assessment of PRX002, an anti-alpha-synuclein monoclonal antibody, in healthy volunteers. Mov Disord. 2017 Feb;32(2):211-218. doi: 10.1002/mds.26878. Epub 2016 Nov 25.
PubMed 27886407
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of PRX002 Administered By Intravenous Infusion in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02157714
- Acronym / sponsor ID
- PRX002-CL002
- Conditions
- Parkinson's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Prothena Biosciences LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Hoffmann-La Roche
- Study start
- Jun 2014
- Primary completion
- Sep 2016 (actual)
- First posted
- 6 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multiple ascending dose study is to determine safety, tolerability, pharmacokinetics and immunogenicity of PRX002 in approximately 60 patients with Parkinson's disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRX002 | Experimental | Drug: PRX002PRX002 |
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Idiopathic Parkinson's disease, Hoehn and Yahr 1-3
- Body weight range of ≥ 45kg/99 lbs to ≤ 110 kg/242 lbs
- Female subjects must be surgically sterile or post-menopausal or if of child-bearing potential must use contraception
- Male subjects and their partners of childbearing potential must use contraception
Key exclusion criteria (3 listed)
- Significant cardiac history
- Abnormal MRI
- Significant laboratory abnormalities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRX002 | Drug | PRX002 |
| Placebo | Other | Placebo |
Primary outcome
Safety and tolerability as determined by number of subjects with adverse events
Time frame: up to 6 months
Determination of pharmacokinetics parameters
Time frame: up to 6 months
maximum concentration (Cmax)
Determination of pharmacokinetics parameters
Time frame: up to 6 months
time of the maximum measured concentration (Tmax)
Determination of pharmacokinetics parameters
Time frame: up to 6 months
area under the concentration-time curve from time zero to the last quantifiable concentration time-point (AUClast)
Determination of pharmacokinetics parameters
Time frame: up to 6 months
area under the concentration-time curve from time zero extrapolated to infinity (AUCinf)
Determination of pharmacokinetics parameters
Time frame: up to 6 months
elimination rate constant
Determination of pharmacokinetics parameters
Time frame: up to 6 months
terminal elimination half life (t½)
Determination of pharmacokinetics parameters
Time frame: up to 6 months
clearance (CL)
Determination of pharmacokinetics parameters
Time frame: up to 6 months
apparent volume of distribution (Vd)
Determination of pharmacokinetics parameters
Time frame: up to 6 months
average concentration over a dosing interval (Cav)
Determination of pharmacokinetics parameters
Time frame: up to 6 months
area under the plasma concentration-time curve for a dosing interval (AUCtau)
Determination of pharmacokinetics parameters
Time frame: up to 6 months
minimum observed concentration (Cmin)
1 secondary outcome
Immunogenicity as determined by measurement of anti-PRX002 antibodies
Time frame: up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2016.
- Derived from this study: PubMed 29913017Jankovic J, Goodman I, Safirstein B, Marmon TK, Schenk DB, Koller M, Zago W, Ness DK, Griffith SG, Grundman M, Soto J, Ostrowitzki S, Boess FG, Martin-Facklam M, Quinn JF, Isaacson SH, Omidvar O, Ellenbogen A, Kinney GG. Safety and Tolerability of Multiple Ascending Doses of PRX002/RG7935, an Anti-alpha-Synuclein Monoclonal Antibody, in Patients With Parkinson Disease: A Randomized Clinical Trial. JAMA Neurol. 2018 Oct 1;75(10):1206-1214. doi: 10.1001/jamaneurol.2018.1487.
- Derived from this study: PubMed 27886407Schenk DB, Koller M, Ness DK, Griffith SG, Grundman M, Zago W, Soto J, Atiee G, Ostrowitzki S, Kinney GG. First-in-human assessment of PRX002, an anti-alpha-synuclein monoclonal antibody, in healthy volunteers. Mov Disord. 2017 Feb;32(2):211-218. doi: 10.1002/mds.26878. Epub 2016 Nov 25.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jay Soto study director
Clinical Trials Prothena Biosciences Inc
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PRX002 in people with Parkinson's Disease, run by Prothena Biosciences Limited at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability as determined by number of subjects with adverse events (time frame: up to 6 months). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02157714, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2016.