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出境医 / 临床实验 / A Study to Assess Tolerability, Safety, Pharmacokinetics and Effect of AZP2006 in Patients With PSP

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

Study Description
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

Study Design
Layout table for study information
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 22, 2021
Estimated Study Completion Date : June 30, 2021
Arms and Interventions
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
Outcome Measures
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


Eligibility Criteria
Layout table for eligibility information
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.
Contacts and Locations

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

Locations
Layout table for location information
France
Hôpital Salengro Recruiting
Lille, Hauts De France, France
Contact: Valerie Santraine    +33 (0) 3 20 44 59 62    Valerie.SANTRAINE@CHRU-LILLE.FR   
Hôpitaux Universitaires Pitié Salpêtrière - Charles Foix Recruiting
Paris, Ile-de-France, France, 75013
Contact: Vanessa Brochard    +33 (0) 1 42 16 57 61    vanessa.brochard-ext@aphp.fr   
Sponsors and Collaborators
AlzProtect SAS
Investigators
Layout table for investigator information
Study Director: Philippe Verwaerde, PhD AlzProtect SAS
Tracking Information
First Submitted Date  ICMJE June 18, 2019
First Posted Date  ICMJE July 5, 2019
Last Update Posted Date July 16, 2020
Actual Study Start Date  ICMJE June 22, 2020
Estimated Primary Completion Date June 22, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2019)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess Tolerability, Safety, Pharmacokinetics and Effect of AZP2006 in Patients With PSP
Official Title  ICMJE 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
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Progressive Supranuclear Palsy
Intervention  ICMJE
  • Drug: AZP2006 oral solution
    Once daily intake in the morning
  • Drug: Placebo oral solution
    Once daily intake in the morning
Study Arms  ICMJE
  • Experimental: 60mg/day/84 days
    Patients randomized in this arm will receive 60 mg of study investigational drug AZP2006 once daily during 84 days.
    Intervention: Drug: AZP2006 oral solution
  • 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.
    Intervention: Drug: AZP2006 oral solution
  • Placebo Comparator: Placebo/84 days
    Patients randomized in this arm will receive placebo solution once daily during 84 days.
    Intervention: Drug: Placebo oral solution
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 1, 2019) 		36
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2021
Estimated Primary Completion Date June 22, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Philippe Verwaerde, PhD +33 9 72 64 97 57 p.verwaerde@alzprotect.com
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04008355
Other Study ID Numbers  ICMJE AZP2006C04
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AlzProtect SAS
Study Sponsor  ICMJE AlzProtect SAS
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Philippe Verwaerde, PhD AlzProtect SAS
PRS Account AlzProtect SAS
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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