A Study to Assess Tolerability, Safety, Pharmacokinetics and Effect of AZP2006 in Patients With PSP
- Conditions
- Progressive Supranuclear Palsy
- Interventions
- Drug: Placebo oral solutionDrug: AZP2006 oral solution
- Registration Number
- NCT04008355
- Lead Sponsor
- AlzProtect SAS
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
- Male and female patients with probable or possible PSP
- Patients must be stable with their medication for at least 30 days prior to the inclusion visit.
- Any history of clinically significant head trauma or cerebrovascular disease or recent history of substance abuse or alcohol abuse and deemed to be clinically significant by the Investigator.
- History of deep brain stimulator (DBS) surgery other than sham surgery for DBS clinical study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo/84 days Placebo oral solution Patients randomized in this arm will receive placebo solution once daily during 84 days. 60mg/day/84 days AZP2006 oral solution Patients randomized in this arm will receive 60 mg of study investigational drug AZP2006 once daily during 84 days. 80mg/day/10 days followed by 50mg/day/74 days AZP2006 oral solution Patients randomized in this arm will receive 80 mg of study investigational drug AZP2006 once daily during 10 days followed by 50 mg of study investigational drug AZP2006 once daily during the next 74 days.
- Primary Outcome Measures
Name Time Method The pharmacokinetics of AZP2006 (12-week treatment period) in plasma, blood, and CSF From Day 1 of Day 84 (12 weeks) To determine the Ctrough of AZP2006 in plasma, blood, and CSF after single and multiple dose administration, once daily for 12 weeks
Number and percentage of patients who prematurely discontinue from the study due to adverse events (AEs) From Day 1 to Day 180 Incidence in pourcentage of treatment-emergent adverse events observed directly by investigator and adverse event spontaneously reported by the patient using concise medical terminology
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Hôpital Salengro
🇫🇷Lille, Hauts De France, France
Hôpitaux Universitaires Pitié Salpêtrière - Charles Foix
🇫🇷Paris, Ile-de-France, France
Hôpital de la Fondation Adolphe de Rothschild
🇫🇷Paris, France