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

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ClinicalTrials.gov Identifier: NCT04008355
Recruitment Status : Recruiting
First Posted : July 5, 2019
Last Update Posted : September 28, 2021
Sponsor:
Information provided by (Responsible Party):
AlzProtect SAS

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.

Condition or disease Intervention/treatment Phase
Progressive Supranuclear Palsy Drug: AZP2006 oral solution Drug: Placebo oral solution Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : June 22, 2020
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022


Arm Intervention/treatment
Experimental: 60mg/day/84 days
Patients randomized in this arm will receive 60 mg of study investigational drug AZP2006 once daily during 84 days.
Drug: AZP2006 oral solution
Once daily intake in the morning

Experimental: 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.
Drug: AZP2006 oral solution
Once daily intake in the morning

Placebo Comparator: Placebo/84 days
Patients randomized in this arm will receive placebo solution once daily during 84 days.
Drug: Placebo oral solution
Once daily intake in the morning




Primary Outcome Measures :
  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



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04008355


Contacts
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Contact: Philippe Verwaerde, PhD +33 9 72 64 97 57 p.verwaerde@alzprotect.com

Locations
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France
Hôpital Salengro Recruiting
Lille, Hauts De France, France
Contact: Morgane Foulon       morgane.foulon@chru-lille.fr   
Contact: Julie Moutarde       julie.moutarde@chru-lille.fr   
Hôpitaux Universitaires Pitié Salpêtrière - Charles Foix Recruiting
Paris, Ile-de-France, France, 75013
Contact: Florence Beauzor       florence.beauzor@icm-institute.org   
Hôpital de la Fondation Adolphe de Rothschild Recruiting
Paris, France, 75019
Contact: Mickael Alexandre Obadia, MD       aobadia@for.paris   
Sponsors and Collaborators
AlzProtect SAS
Investigators
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Study Director: Philippe Verwaerde, PhD AlzProtect SAS
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Responsible Party: AlzProtect SAS
ClinicalTrials.gov Identifier: NCT04008355    
Other Study ID Numbers: AZP2006C04
First Posted: July 5, 2019    Key Record Dates
Last Update Posted: September 28, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Supranuclear Palsy, Progressive
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Ophthalmoplegia
Ocular Motility Disorders
Cranial Nerve Diseases
Tauopathies
Neurodegenerative Diseases
Paralysis
Neurologic Manifestations
Eye Diseases
Pharmaceutical Solutions