Progressive Supranuclear PalsyPhase 2NCT04008355
A Study to Assess Tolerability, Safety, Pharmacokinetics and Effect of AZP2006 in Patients With PSP
A Phase 2 study testing AZP2006 oral solution in people with Progressive Supranuclear Palsy, run by AlzProtect SAS at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Progressive Supranuclear Palsy
- What is being tested?
- AZP2006 oral solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 3 sitesFrance
- Study dates
- 22 Jun 2020to 30 Sep 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
France3 sites
Hôpital Salengro
Lille, Hauts-de-France, 59037
Hôpital de la Fondation Adolphe de Rothschild
Paris, 75019
Hôpitaux Universitaires Pitié Salpêtrière - Charles Foix
Paris, Île-de-France Region, 75013
About this study
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
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.
Read the detailed description
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.
- Conditions
- Progressive Supranuclear Palsy
- Being tested
- AZP2006 oral solution, Placebo oral solution
- Medical subject headings
- Supranuclear Palsy, Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZP2006 oral solutionDrug
Once daily intake in the morning
Placebo oral solutionDrug
Once daily intake in the morning
| Study group | Role | What they receive |
|---|---|---|
| 60mg/day/84 days | Experimental | Patients randomized in this arm will receive 60 mg of study investigational drug AZP2006 once daily during 84 days. Receives: 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. Receives: Drug: AZP2006 oral solution |
| Placebo/84 days | Placebo comparator | Patients randomized in this arm will receive placebo solution once daily during 84 days. Receives: Drug: Placebo oral solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From Day 1 of Day 84 (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start22 Jun 2020
- Primary completion18 Jul 2022
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progressive Supranuclear PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- AlzProtect SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philippe Verwaerde, PhD, Study director, AlzProtect SAS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04008355
- Sponsor's protocol ID
- AZP2006C04
- Status last verified
- Mar 2025
- First submitted
- 18 Jun 2019
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04008355
- Acronym / sponsor ID
- AZP2006C04
- Conditions
- Progressive Supranuclear Palsy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- AlzProtect SASIndustry (pharma, biotech, devices)
- Study start
- 22 Jun 2020 (actual)
- Primary completion
- 18 Jul 2022 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 60mg/day/84 days | Experimental | Drug: AZP2006 oral solutionPatients randomized in this arm will receive 60 mg of study investigational drug AZP2006 once daily during 84 days. |
| 80mg/day/10 days followed by 50mg/day/74 days | Experimental | Drug: AZP2006 oral solutionPatients 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. |
| Placebo/84 days | Placebo comparator | Drug: Placebo oral solutionPatients randomized in this arm will receive placebo solution once daily during 84 days. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZP2006 oral solutionOnce daily intake in the morning | Drug | 60mg/day/84 days, 80mg/day/10 days followed by 50mg/day/74 days |
| Placebo oral solutionOnce daily intake in the morning | Drug | Placebo/84 days |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Verwaerde, PhD study director
AlzProtect SAS
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AZP2006 oral solution in people with Progressive Supranuclear Palsy, run by AlzProtect SAS at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and percentage of patients who prematurely discontinue from the study due to adverse events (AEs) (time frame: From Day 1 to Day 180). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.