A Phase 1 interventional study of PRX002 and Placebo in Parkinson's Disease, sponsored by Prothena Biosciences Limited. Completed at 8 sites in United States. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-10-21.
Sponsored by Prothena Biosciences Limited · Phase 1, Interventional, and Treatment
This multiple ascending dose study is to determine safety, tolerability, pharmacokinetics and immunogenicity of PRX002 in approximately 60 patients with Parkinson's disease.
4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
This study's planned enrollment of 64 is above the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Prothena Biosciences Limited is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PRX002
Drug: PRX002
Placebo
Other: Placebo
Safety and tolerability as determined by number of subjects with adverse events
Time frame: up to 6 months
Determination of pharmacokinetics parameters
maximum concentration (Cmax)
Time frame: up to 6 months
Determination of pharmacokinetics parameters
time of the maximum measured concentration (Tmax)
Time frame: 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)
Time frame: up to 6 months
Determination of pharmacokinetics parameters
area under the concentration-time curve from time zero extrapolated to infinity (AUCinf)
Time frame: up to 6 months
Determination of pharmacokinetics parameters
elimination rate constant
Time frame: up to 6 months
Determination of pharmacokinetics parameters
terminal elimination half life (t½)
Time frame: up to 6 months
Determination of pharmacokinetics parameters
clearance (CL)
Time frame: up to 6 months
Determination of pharmacokinetics parameters
apparent volume of distribution (Vd)
Time frame: up to 6 months
Determination of pharmacokinetics parameters
average concentration over a dosing interval (Cav)
Time frame: up to 6 months
Determination of pharmacokinetics parameters
area under the plasma concentration-time curve for a dosing interval (AUCtau)
Time frame: up to 6 months
Determination of pharmacokinetics parameters
minimum observed concentration (Cmin)
Time frame: up to 6 months
Immunogenicity as determined by measurement of anti-PRX002 antibodies
Multiple clinical and exploratory biomarkers will be assessed
Time frame: up to 3 months
This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Prasinezumab
Prothena Biosciences Limited