Recent Updates
Recently added Catalysts

PRX002

Phase 1

Parkinson's Disease | Small molecule | Neurology |Prothena Corporation plc|Last Updated: Oct 21, 2016

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment104

FDA Designations

No designations recorded

Clinical trial landscape

PRX002 · 2 trials · 1 indication

Phase 1 2
NCT02157714Multiple Ascending Dose Study of PRX002 in Patients With Parkinson's DiseaseParkinson's Disease
COMPLETED64 Analytics
NCT02095171Single Ascending Dose Study of PRX002 in Healthy SubjectsParkinson's Disease
COMPLETED40 Analytics
PHASE1COMPLETED
Multiple Ascending Dose Study of PRX002 in Patients With Parkinson's Disease
Parkinson's DiseaseUnlock trial analytics
PHASE1COMPLETED
Single Ascending Dose Study of PRX002 in Healthy Subjects
Parkinson's DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and tolerability as determined by number of subjects with adverse events
up to 6 months
Determination of pharmacokinetics parameters
up to 6 months

maximum concentration (Cmax)

Secondary Endpoints

Immunogenicity as determined by measurement of anti-PRX002 antibodies
up to 3 months
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PRX002EXPERIMENTALPRX002
PlaceboPLACEBO_COMPARATORPlacebo

Interventions

NameTypeDescription
PRX002DRUG -
PlaceboOTHER -
Unlock Study Design Details

Eligibility Criteria

Age Range40 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * 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 childbearin...

Countries:United States
Unlock Eligibility Criteria

Frequently asked questions about PRX002

What is PRX002 used for in Parkinson's Disease?

PRX002 is an investigational small molecule being developed for the treatment of Parkinson's Disease. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. Two Phase 1 trials have been completed, one in healthy subjects and one in patients with Parkinson's Disease.

Who makes PRX002?

PRX002 is being developed by Prothena Corporation plc, a biopharmaceutical company traded on the NASDAQ under the ticker symbol PRTA. The company is conducting clinical trials for this investigational drug in the United States.

What phase is PRX002 in?

PRX002 is in Phase 1 clinical development. Two Phase 1 trials have been completed, including a single ascending dose study in healthy subjects and a multiple ascending dose study in patients with Parkinson's Disease. The drug is investigational and has not received FDA approval.

What clinical trials is PRX002 in?

PRX002 has completed two Phase 1 clinical trials. The first, NCT02095171, was a single ascending dose study in 40 healthy subjects. The second, NCT02157714, was a multiple ascending dose study in 64 patients with Parkinson's Disease. Both trials were conducted in the United States.

Is PRX002 FDA approved?

PRX002 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. Two Phase 1 trials have been completed, but the drug has not yet progressed to later-stage trials or received regulatory approval for the treatment of Parkinson's Disease.