A phase 2 study to assess tolerability, safety, pharmacokinetics and effect of AZP2006 at different doses versus placebo on cerebrospinal fluid biomarkers in 36 patients with progressive supranuclear palsy. The patient study duration is 29 weeks including a washout period.
This is a randomized, double blind, placebo controlled, parallel group study comparing 2 doses of AZP2006 (60 mg Once daily \[QD\] during the 12-week treatment period or 80 mg for 10 days followed by 50 mg QD) with placebo in 36 men and women aged ≥40 years and ≤80 years and diagnosed with probable or possible PSP according to Movement Disorder Society PSP (MDS-PSP) criteria. Patients were assessed for eligibility at baseline. Eligible patients were randomized on Day -1 in a 1:1:1 ratio into one of the following 3 study intervention groups based on a randomization scheme with blocks stratified by center using an interactive web response system (IWRS): 1. 60 mg AZP2006/day during the 12-week treatment period; 2. 80 mg AZP2006/day for 10 days followed by 50 mg AZP2006/day; 3. Placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
36
Once daily intake in the morning
Once daily intake in the morning
Hôpital Salengro
Lille, Hauts-de-France, France
Hôpital de la Fondation Adolphe de Rothschild
Paris, France
Hôpitaux Universitaires Pitié Salpêtrière - Charles Foix
Paris, Île-de-France Region, France
Number and percentage of patients who prematurely discontinue from the study due to adverse events (AEs)
Incidence in pourcentage of treatment-emergent adverse events observed directly by investigator and adverse event spontaneously reported by the patient using concise medical terminology
Time frame: From Day 1 to Day 180
The pharmacokinetics of AZP2006 (12-week treatment period) in plasma, blood, and CSF
To determine the Cmax of AZP2006 in plasma, blood, and CSF after single and multiple dose administration, once daily for 12 weeks
Time frame: From Day 1 of Day 84 (12 weeks)
The pharmacokinetics of AZP2006 (12-week treatment period) in plasma, blood, and CSF
To determine the tmax of AZP2006 in plasma, blood, and CSF after single and multiple dose administration, once daily for 12 weeks
Time frame: From Day 1 of Day 84 (12 weeks)
The pharmacokinetics of AZP2006 (12-week treatment period) in plasma, blood, and CSF
To determine the kel of AZP2006 in plasma, blood, and CSF after single and multiple dose administration, once daily for 12 weeks
Time frame: From Day 1 of Day 84 (12 weeks)
The pharmacokinetics of AZP2006 (12-week treatment period) in plasma, blood, and CSF
To determine the Clast of AZP2006 in plasma, blood, and CSF after single and multiple dose administration, once daily for 12 weeks
Time frame: From Day 1 of Day 84 (12 weeks)
The pharmacokinetics of AZP2006 (12-week treatment period) in plasma, blood, and CSF
To determine the AUC 0-10 of AZP2006 in plasma, blood, and CSF after single and multiple dose administration, once daily for 12 weeks
Time frame: From Day 1 of Day 84 (12 weeks)
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The pharmacokinetics of AZP2006 (12-week treatment period) in plasma, blood, and CSF
To determine the AUC 0-24 of AZP2006 in plasma, blood, and CSF after single and multiple dose administration, once daily for 12 weeks
Time frame: From Day 1 of Day 84 (12 weeks)
The pharmacokinetics of AZP2006 (12-week treatment period) in plasma, blood, and CSF
To determine the AUC 0-t of AZP2006 in plasma, blood, and CSF after single and multiple dose administration, once daily for 12 weeks
Time frame: From Day 1 of Day 84 (12 weeks)
The pharmacokinetics of AZP2006 (12-week treatment period) in plasma, blood, and CSF
To determine the t1/2 of AZP2006 in plasma, blood, and CSF after single and multiple dose administration, once daily for 12 weeks
Time frame: From Day 1 of Day 84 (12 weeks)
The pharmacokinetics of AZP2006 (12-week treatment period) in plasma, blood, and CSF
To determine the tlast of AZP2006 in plasma, blood, and CSF after single and multiple dose administration, once daily for 12 weeks
Time frame: From Day 1 of Day 84 (12 weeks)
The pharmacokinetics of AZP2006 (12-week treatment period) in plasma, blood, and CSF
To determine the %AUCextra of AZP2006 in plasma, blood, and CSF after single and multiple dose administration, once daily for 12 weeks
Time frame: From Day 1 of Day 84 (12 weeks)
The pharmacokinetics of AZP2006 (12-week treatment period) in plasma, blood, and CSF
To determine the CL/F of AZP2006 in plasma, blood, and CSF after single and multiple dose administration, once daily for 12 weeks
Time frame: From Day 1 of Day 84 (12 weeks)
The pharmacokinetics of AZP2006 (12-week treatment period) in plasma, blood, and CSF
To determine the Vd/F of AZP2006 in plasma, blood, and CSF after single and multiple dose administration, once daily for 12 weeks
Time frame: From Day 1 of Day 84 (12 weeks)
The pharmacokinetics of AZP2006 (12-week treatment period) in plasma, blood, and CSF
To determine the Ctrough of AZP2006 in plasma, blood, and CSF after single and multiple dose administration, once daily for 12 weeks
Time frame: From Day 1 of Day 84 (12 weeks)