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

AlzProtect

Status and phase: Completed; Phase 2

Conditions: Progressive Supranuclear Palsy

Treatments: Drug: AZP2006 oral solution; Drug: Placebo oral solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT04008355

AZP2006C04

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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36 participants in 3 patient groups, including a placebo group

60mg/day/84 days

Experimental group

Description:

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

Treatment:

Drug: AZP2006 oral solution

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

Experimental group

Description:

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.

Treatment:

Drug: AZP2006 oral solution

Placebo/84 days

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo oral solution