A Study to Assess Tolerability, Safety, Pharmacokinetics and Effect of AZP2006 in Patients With PSP

Progressive Supranuclear Palsy Clinical Trial

Official title:

A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess Tolerability, Safety, Pharmacokinetics and Effect of AZP2006 on Cerebrospinal Fluid Biomarkers in 36 Patients With Progressive Supranuclear Palsy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04008355
• Other study ID #: AZP2006C04
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: June 22, 2020
• Est. completion date: July 1, 2024

Study information

• Verified date: August 2023
• Source: AlzProtect SAS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 36
• Est. completion date: July 1, 2024
• Est. primary completion date: July 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Progressive Supranuclear Palsy
• Supranuclear Palsy, Progressive

Intervention

Drug:
• AZP2006 oral solution
Once daily intake in the morning
• Placebo oral solution
Once daily intake in the morning

Locations

Country	Name	City	State
France	Hôpital Salengro	Lille	Hauts De France
France	Hôpital de la Fondation Adolphe de Rothschild	Paris
France	Hôpitaux Universitaires Pitié Salpêtrière - Charles Foix	Paris	Ile-de-France

Sponsors (1)

Lead Sponsor	Collaborator
AlzProtect SAS

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	From Day 1 to Day 180
Primary	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	From Day 1 of Day 84 (12 weeks)
Primary	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	From Day 1 of Day 84 (12 weeks)
Primary	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	From Day 1 of Day 84 (12 weeks)
Primary	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	From Day 1 of Day 84 (12 weeks)
Primary	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	From Day 1 of Day 84 (12 weeks)
Primary	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	From Day 1 of Day 84 (12 weeks)
Primary	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	From Day 1 of Day 84 (12 weeks)
Primary	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	From Day 1 of Day 84 (12 weeks)
Primary	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	From Day 1 of Day 84 (12 weeks)
Primary	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	From Day 1 of Day 84 (12 weeks)
Primary	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	From Day 1 of Day 84 (12 weeks)
Primary	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	From Day 1 of Day 84 (12 weeks)
Primary	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	From Day 1 of Day 84 (12 weeks)