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

NCT ID: NCT04008355

Last Updated: 2025-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-22
• Study Completion Date: 2024-09-30

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.

Conditions

Progressive Supranuclear Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

60mg/day/84 days

Patients randomized in this arm will receive 60 mg of study investigational drug AZP2006 once daily during 84 days.

Group Type: EXPERIMENTAL

AZP2006 oral solution

Intervention Type: DRUG

Once daily intake in the morning

80mg/day/10 days followed by 50mg/day/74 days

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.

Group Type: EXPERIMENTAL

AZP2006 oral solution

Intervention Type: DRUG

Once daily intake in the morning

Placebo/84 days

Patients randomized in this arm will receive placebo solution once daily during 84 days.

Group Type: PLACEBO_COMPARATOR

Placebo oral solution

Intervention Type: DRUG

Once daily intake in the morning

Interventions

AZP2006 oral solution

Once daily intake in the morning

Intervention Type: DRUG

Placebo oral solution

Once daily intake in the morning

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AlzProtect SAS

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philippe Verwaerde, PhD

Role: STUDY_DIRECTOR

AlzProtect SAS

Locations

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

Countries

France

Other Identifiers

AZP2006C04

Identifier Type: -

Identifier Source: org_study_id