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NCT Number: NCT04008355

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

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.

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Key information

Conditions

Progressive Supranuclear Palsy Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Cranial Nerve Diseases Eye Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Ocular Motility Disorders Ophthalmoplegia Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Supranuclear Palsy, Progressive Tauopathies

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hôpital Salengro, Lille, Hauts-de-France, France

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About this study

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):

  • 60 mg AZP2006/day during the 12-week treatment period;
  • 80 mg AZP2006/day for 10 days followed by 50 mg AZP2006/day;
  • Placebo.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AZP2006 oral solution

Drug

Once daily intake in the morning

Placebo Oral Solution

Drug

Once daily intake in the morning

Primary outcomes

  1. Number and percentage of patients who prematurely discontinue from the study due to adverse events (AEs)

    Time frame: 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

  2. The pharmacokinetics of AZP2006 (12-week treatment period) in plasma, blood, and CSF

    Time frame: From Day 1 of Day 84 (12 weeks)

    To determine the Cmax of AZP2006 in plasma, blood, and CSF after single and multiple dose administration, once daily for 12 weeks

  3. The pharmacokinetics of AZP2006 (12-week treatment period) in plasma, blood, and CSF

    Time frame: From Day 1 of Day 84 (12 weeks)

    To determine the tmax of AZP2006 in plasma, blood, and CSF after single and multiple dose administration, once daily for 12 weeks

  4. The pharmacokinetics of AZP2006 (12-week treatment period) in plasma, blood, and CSF

    Time frame: From Day 1 of Day 84 (12 weeks)

    To determine the kel of AZP2006 in plasma, blood, and CSF after single and multiple dose administration, once daily for 12 weeks

  5. The pharmacokinetics of AZP2006 (12-week treatment period) in plasma, blood, and CSF

    Time frame: From Day 1 of Day 84 (12 weeks)

    To determine the Clast of AZP2006 in plasma, blood, and CSF after single and multiple dose administration, once daily for 12 weeks

  6. The pharmacokinetics of AZP2006 (12-week treatment period) in plasma, blood, and CSF

    Time frame: From Day 1 of Day 84 (12 weeks)

    To determine the AUC 0-10 of AZP2006 in plasma, blood, and CSF after single and multiple dose administration, once daily for 12 weeks

  7. The pharmacokinetics of AZP2006 (12-week treatment period) in plasma, blood, and CSF

    Time frame: From Day 1 of Day 84 (12 weeks)

    To determine the AUC 0-24 of AZP2006 in plasma, blood, and CSF after single and multiple dose administration, once daily for 12 weeks

  8. The pharmacokinetics of AZP2006 (12-week treatment period) in plasma, blood, and CSF

    Time frame: From Day 1 of Day 84 (12 weeks)

    To determine the AUC 0-t of AZP2006 in plasma, blood, and CSF after single and multiple dose administration, once daily for 12 weeks

  9. The pharmacokinetics of AZP2006 (12-week treatment period) in plasma, blood, and CSF

    Time frame: From Day 1 of Day 84 (12 weeks)

    To determine the t1/2 of AZP2006 in plasma, blood, and CSF after single and multiple dose administration, once daily for 12 weeks

  10. The pharmacokinetics of AZP2006 (12-week treatment period) in plasma, blood, and CSF

    Time frame: From Day 1 of Day 84 (12 weeks)

    To determine the tlast of AZP2006 in plasma, blood, and CSF after single and multiple dose administration, once daily for 12 weeks

  11. The pharmacokinetics of AZP2006 (12-week treatment period) in plasma, blood, and CSF

    Time frame: From Day 1 of Day 84 (12 weeks)

    To determine the %AUCextra of AZP2006 in plasma, blood, and CSF after single and multiple dose administration, once daily for 12 weeks

  12. The pharmacokinetics of AZP2006 (12-week treatment period) in plasma, blood, and CSF

    Time frame: From Day 1 of Day 84 (12 weeks)

    To determine the CL/F of AZP2006 in plasma, blood, and CSF after single and multiple dose administration, once daily for 12 weeks

  13. The pharmacokinetics of AZP2006 (12-week treatment period) in plasma, blood, and CSF

    Time frame: From Day 1 of Day 84 (12 weeks)

    To determine the Vd/F of AZP2006 in plasma, blood, and CSF after single and multiple dose administration, once daily for 12 weeks

  14. The pharmacokinetics of AZP2006 (12-week treatment period) in plasma, blood, and CSF

    Time frame: 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

Sponsors and collaborators

Lead sponsor

AlzProtect SAS

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2022
Study completion
2024
First posted
Jul 5, 2019
Registry last updated
Mar 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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