NCT04008355

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2020

Typical duration for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2019

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 5, 2019

Completed
12 months until next milestone

Study Start

First participant enrolled

June 22, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 18, 2022

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

March 17, 2025

Status Verified

March 1, 2025

Enrollment Period

2.1 years

First QC Date

June 18, 2019

Last Update Submit

March 13, 2025

Conditions

Progressive Supranuclear Palsy

Outcome Measures

Primary Outcomes (14)

  • 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

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

Study Arms (3)

60mg/day/84 days

EXPERIMENTAL

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

Drug: AZP2006 oral solution

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

EXPERIMENTAL

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.

Drug: AZP2006 oral solution

Placebo/84 days

PLACEBO COMPARATOR

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

Drug: Placebo oral solution

Interventions

AZP2006 oral solutionDRUG

Once daily intake in the morning

60mg/day/84 days80mg/day/10 days followed by 50mg/day/74 days
Placebo oral solutionDRUG

Once daily intake in the morning

Placebo/84 days

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female patients with probable or possible PSP

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hôpital Salengro

Lille, Hauts-de-France, 59037, France

Location

Hôpital de la Fondation Adolphe de Rothschild

Paris, 75019, France

Location

Hôpitaux Universitaires Pitié Salpêtrière - Charles Foix

Paris, Île-de-France Region, 75013, France

Location

MeSH Terms

Conditions

Supranuclear Palsy, Progressive

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersOphthalmoplegiaOcular Motility DisordersCranial Nerve DiseasesTauopathiesNeurodegenerative DiseasesParalysisNeurologic ManifestationsEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Philippe Verwaerde, PhD

    AlzProtect SAS

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2019

First Posted

July 5, 2019

Study Start

June 22, 2020

Primary Completion

July 18, 2022

Study Completion

September 30, 2024

Last Updated

March 17, 2025

Record last verified: 2025-03

Locations

FR(3)