Brief Title
A Study to Assess Tolerability, Safety, Pharmacokinetics and Effect of AZP2006 in Patients With PSP
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
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Number and percentage of patients who prematurely discontinue from the study due to adverse events (AEs)
Condition
Progressive Supranuclear Palsy
Intervention
AZP2006 oral solution
Study Arms / Comparison Groups
60mg/day/84 days
Description: Patients randomized in this arm will receive 60 mg of study investigational drug AZP2006 once daily during 84 days.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
36
Start Date
June 22, 2020
Completion Date
July 18, 2022
Primary Completion Date
July 18, 2022
Eligibility 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.
Gender
All
Ages
40 Years - 80 Years
Accepts Healthy Volunteers
No
Contacts
Philippe Verwaerde, PhD, ,
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT04008355
Organization ID
AZP2006C04
Responsible Party
Sponsor
Study Sponsor
AlzProtect SAS
Study Sponsor
Philippe Verwaerde, PhD, Study Director, AlzProtect SAS
Verification Date
February 2023