Alzheimer Disease, Early OnsetPhase 1NCT03784300
A Safety Study of PTI-125 in Healthy Volunteers
A Phase 1 study testing 50 mg PTI-125, 100 mg PTI-125 and 200 mg PTI-125 in people with Alzheimer Disease, Early Onset and Alzheimer Disease, run by Pain Therapeutics at 1 site in United States.
Trial summary
A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose, Pharmacokinetic and Safety Study of PTl-125 in Healthy Volunteers Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Early Onset, Alzheimer Disease
- What is being tested?
- 50 mg PTI-125, 100 mg PTI-125 and 200 mg PTI-125
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2017to 27 Mar 2018
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female subjects between 18 and 45 years of age, inclusive.
- The subject has a body mass index (BMI) within 18-30 kg/m2 (inclusive).
- The subject is in good health as determined by medical history and physical examination and clinical laboratory parameters.
- The subject is willing and able to speak, read, and understand English and provide written informed consent.
- The subject is a non-smoker for at least 12 months. If a former smoker, the reason for stopping must be evaluated.
- Females who are physically incapable of childbearing defined as postmenopausal, or surgically sterile (hysterectomy, bilateral tubal ligation, bilateral oophorectomy or an Essure procedure). Appropriate documentation (ex; medical record) of the surgical sterilization procedure to be obtained and held within the subject's study file.
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- The subject must agree to comply with the drawing of blood samples for the PK assessments.
- The subject is willing and able to comply with all testing and requirements defined in the protocol.
- The subject is willing and able to remain at the study site unit for the duration of the confinement period and return for the outpatient visit.
Who cannot join
- The subject has any relevant deviations from normal in physical examination, electrocardiogram (ECG), or clinical laboratory tests, as evaluated by the investigator.
- The subject has had a clinically significant illness within 30 days of Check-in.
- The subject has a history of significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, or metabolic disease.
- The subject has used any prescription medication within 14 days of dosing or overthe- counter (OTC) medication within 48 h of dosing or intends to use any prescription medication or OTC medication during the study that may interfere with the evaluation of study medication.
- The subject has used alcohol, caffeine or xanthine-containing products 48 h before dosing or intends to use any of these products during the study.
- The subject has used grapefruit, grapefruit juice, or grapefruit-containing products days before dosing or intends to use any of these products during the study.
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- The subject has a history of substance abuse or a positive ethanol breath test, urine cotinine, or urine drug screen at screening or at check-in. The subject has a positive serum hepatitis B surface antigen or positive HCV antibody test at the Screening Visit.
- The subject has a positive HIV test at the Screening Visit.
- Female subject is pregnant or breastfeeding.
- The subject has received an investigational drug within 30 days of Check-in.
- The subject has donated or lost a significant volume of blood (>450 mL) within 4 weeks prior to the study.
- The subject is unwilling to reside in the study unit for the duration of the study or to cooperate fully with the investigator or site personnel.
- The subject has an AST/ALT or total bilirubin greater than the ULN. One repeat test will be allowed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose, Pharmacokinetic and Safety Study of PTl-125 in Healthy Volunteers
A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose, Pharmacokinetic and Safety Study of PTl-125 in Healthy Volunteers
Read the detailed description
This was a Phase I, single center, randomized, double-blind, placebo-controlled, single ascending dose (SAD) study in healthy volunteers, 18 to 45 years of age. A total of twenty-four (24) subjects were enrolled into the study in one of three dose cohorts. Each cohort contained eight subjects; six subjects received PTI-125 and two received placebo. Three doses of PTI-125 oral solution (50, 100, and 200 mg) or placebo solution were administered to respective cohorts.
The study included a screening period (Day -28 to Day -1), an inpatient treatment period (Day 0 through Day 4), and a follow-up visit (Day 7). Subjects reported to the clinic on the day before dosing and were randomized to receive either a single dose of orally administered PTI-125 or placebo. Each dose was administered following an overnight fast of at least 10 hours.
For each dose level, dosing was staggered such that two subjects (one active and one placebo) were dosed prior to the rest of the group. After a minimum of 24 hours and review of all 24-hour safety assessments (electrocardiogram [ECG], a brief physical examination, vital signs, and laboratory assessments) an independent Data Safety Monitoring Board/Data Monitoring Committee (DSMB/DMC) determined whether the remaining 6 subjects were to be dosed.
Pharmacokinetic blood samples were obtained prior to dosing and at specified intervals during the study (0-72 hours post-dose). Blood draws for laboratory testing were performed prior to dosing and at 24 hours post dose. After safety assessments of ECG, vital signs, and a brief physical exam at 72 hours, subjects were discharged from the clinic and returned 7 days post-dose for a final safety assessment.
- Conditions
- Alzheimer Disease, Early Onset, Alzheimer Disease
- Being tested
- 50 mg PTI-125, 100 mg PTI-125, 200 mg PTI-125
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
50 mg PTI-125Drug
PTI-125 50 mg Oral Solution
100 mg PTI-125Drug
PTI-125 100 mg Oral Solution
200 mg PTI-125Drug
PTI-125 200 mg Oral Solution
| Study group | Role | What they receive |
|---|---|---|
| 50 mg PTI-125 | Active comparator | Six (6) subjects will receive a single orally administered dose of 50 mg PTI-125 in this cohort. Receives: Drug: 50 mg PTI-125 |
| 50 mg PTI-125 Placebo | Placebo comparator | Two (2) subjects will receive a single orally administered dose of 50 mg Placebo PTI-125 in this cohort. Receives: Drug: 50 mg PTI-125 |
| 100 mg PTI-125 | Active comparator | Six (6) subjects will receive a single orally administered dose of 100 mg PTI-125 in this cohort. Receives: Drug: 100 mg PTI-125 |
| 100 mg PTI-125 Placebo | Placebo comparator | Two (2) subjects will receive a single orally administered dose of 100 mg Placebo PTI-125 in this cohort. Receives: Drug: 100 mg PTI-125 |
| 200 mg PTI-125 | Active comparator | Six (6) subjects will receive a single orally administered dose of 200 mg PTI-125 in this cohort. Receives: Drug: 200 mg PTI-125 |
| 200 mg PTI-125 Placebo | Placebo comparator | Two (2) subjects will receive a single orally administered dose of 200 mg Placebo PTI-125 in this cohort. Receives: Drug: 200 mg PTI-125 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax)
The peak drug concentration will be obtained directly from the data without interpolation.
Measured: Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours.
Time to Maximum Plasma Concentration (Tmax) (Tmax)
The time to peak drug concentration will be obtained directly from the data without interpolation
Measured: Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours.
Time to Last Quantifiable Plasma Concentration (Tlast)
The time to the last quantifiable drug concentration will be obtained directly from the data without interpolation.
Measured: Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours.
Last Quantifiable Plasma Concentration (Clast)
The concentration of the last quantifiable drug will be obtained directly from the data without interpolation concentration
Measured: Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours.
Elimination Rate Constant (λz)
The elimination rate constant (λz) will be calculated.
Measured: Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours.
Termination Elimination Half-Life (T1/2)
The terminal elimination half-life (T1/2) will be calculated.
Measured: Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours.
Area Under the Curve (AUC)
The AUC from time zero to the time of the last quantifiable concentration (AUClast) will be calculated.
Measured: Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours.
Area Under the Curve to Infinity (AUCinf)
The AUC from time zero extrapolated to infinity (AUCinf) will be calculate.
Measured: Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours.
Percent Extrapolated of Area Under the Curve to Infinity (AUCextrap[%]).
The percentage of AUCinf based on extrapolation (AUCextrap[%]).
Measured: Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours.
Oral Clearance (Cl/F)
The apparent oral clearance will be calculated.
Measured: Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours.
Volume of Distribution (Vz/F)
Vz/F, apparent volume of distribution will be calculated.
Measured: Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2018
- Study start18 Aug 2017
- Primary completion9 Oct 2017
- Study completion27 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alzheimer Disease, Early OnsetStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single center, randomized, double-blind, placebo controlled, SAD study of three escalating doses of PTI-125. A total of 24 healthy subjects enrolled in one of three dose cohorts. Each cohort will contain 8 subjects; six receive PTI-125 and two receive placebo. Three SAD does of PTI-125 oral solution (50, 100 or 200 mg) or placebo solution will be administered.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pain Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- George J Atiee, MD, Principal investigator, Worldwide Clinical Trials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03784300
- Sponsor's protocol ID
- PTI-125-01
- Other IDs
- 1R44AG056166
- Status last verified
- May 2021
- First submitted
- 18 Dec 2018
- Last updated
- 10 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose, Pharmacokinetic and Safety Study of PTl-125 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03784300
- Acronym / sponsor ID
- PTI-125-01
- Conditions
- Alzheimer Disease, Early Onset, Alzheimer Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Pain TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 18 Aug 2017 (actual)
- Primary completion
- 9 Oct 2017 (actual)
- Study completion
- 27 Mar 2018 (actual)
- First posted
- 21 Dec 2018 (actual)
- Results
- Posted 10 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose, Pharmacokinetic and Safety Study of PTl-125 in Healthy Volunteers
Detailed description
This was a Phase I, single center, randomized, double-blind, placebo-controlled, single ascending dose (SAD) study in healthy volunteers, 18 to 45 years of age. A total of twenty-four (24) subjects were enrolled into the study in one of three dose cohorts. Each cohort contained eight subjects; six subjects received PTI-125 and two received placebo. Three doses of PTI-125 oral solution (50, 100, and 200 mg) or placebo solution were administered to respective cohorts.
The study included a screening period (Day -28 to Day -1), an inpatient treatment period (Day 0 through Day 4), and a follow-up visit (Day 7). Subjects reported to the clinic on the day before dosing and were randomized to receive either a single dose of orally administered PTI-125 or placebo. Each dose was administered following an overnight fast of at least 10 hours.
For each dose level, dosing was staggered such that two subjects (one active and one placebo) were dosed prior to the rest of the group. After a minimum of 24 hours and review of all 24-hour safety assessments (electrocardiogram [ECG], a brief physical examination, vital signs, and laboratory assessments) an independent Data Safety Monitoring Board/Data Monitoring Committee (DSMB/DMC) determined whether the remaining 6 subjects were to be dosed.
Pharmacokinetic blood samples were obtained prior to dosing and at specified intervals during the study (0-72 hours post-dose). Blood draws for laboratory testing were performed prior to dosing and at 24 hours post dose. After safety assessments of ECG, vital signs, and a brief physical exam at 72 hours, subjects were discharged from the clinic and returned 7 days post-dose for a final safety assessment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- Single center, randomized, double-blind, placebo controlled, SAD study of three escalating doses of PTI-125. A total of 24 healthy subjects enrolled in one of three dose cohorts. Each cohort will contain 8 subjects; six receive PTI-125 and two receive placebo. Three SAD does of PTI-125 oral solution (50, 100 or 200 mg) or placebo solution will be administered.
| Arm | Type | Receives |
|---|---|---|
| 50 mg PTI-125 | Active comparator | Drug: 50 mg PTI-125Six (6) subjects will receive a single orally administered dose of 50 mg PTI-125 in this cohort. |
| 50 mg PTI-125 Placebo | Placebo comparator | Drug: 50 mg PTI-125Two (2) subjects will receive a single orally administered dose of 50 mg Placebo PTI-125 in this cohort. |
| 100 mg PTI-125 | Active comparator | Drug: 100 mg PTI-125Six (6) subjects will receive a single orally administered dose of 100 mg PTI-125 in this cohort. |
| 100 mg PTI-125 Placebo | Placebo comparator | Drug: 100 mg PTI-125Two (2) subjects will receive a single orally administered dose of 100 mg Placebo PTI-125 in this cohort. |
| 200 mg PTI-125 | Active comparator | Drug: 200 mg PTI-125Six (6) subjects will receive a single orally administered dose of 200 mg PTI-125 in this cohort. |
| 200 mg PTI-125 Placebo | Placebo comparator | Drug: 200 mg PTI-125Two (2) subjects will receive a single orally administered dose of 200 mg Placebo PTI-125 in this cohort. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Male or female subjects between 18 and 45 years of age, inclusive.
- The subject has a body mass index (BMI) within 18-30 kg/m2 (inclusive).
- The subject is in good health as determined by medical history and physical examination and clinical laboratory parameters.
- The subject is willing and able to speak, read, and understand English and provide written informed consent.
- The subject is a non-smoker for at least 12 months. If a former smoker, the reason for stopping must be evaluated.
Key exclusion criteria (13 listed)
- The subject has any relevant deviations from normal in physical examination, electrocardiogram (ECG), or clinical laboratory tests, as evaluated by the investigator.
- The subject has had a clinically significant illness within 30 days of Check-in.
- The subject has a history of significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, or metabolic disease.
- The subject has used any prescription medication within 14 days of dosing or overthe- counter (OTC) medication within 48 h of dosing or intends to use any prescription medication or OTC medication during the study that may interfere with the evaluation of study medication.
- The subject has used alcohol, caffeine or xanthine-containing products 48 h before dosing or intends to use any of these products during the 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 |
|---|---|---|
| 50 mg PTI-125PTI-125 50 mg Oral Solution | Drug | 50 mg PTI-125, 50 mg PTI-125 Placebo |
| 100 mg PTI-125PTI-125 100 mg Oral Solution | Drug | 100 mg PTI-125, 100 mg PTI-125 Placebo |
| 200 mg PTI-125PTI-125 200 mg Oral Solution | Drug | 200 mg PTI-125, 200 mg PTI-125 Placebo |
Primary outcome
Maximum Plasma Concentration (Cmax)
Time frame: Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours.
The peak drug concentration will be obtained directly from the data without interpolation.
Time to Maximum Plasma Concentration (Tmax) (Tmax)
Time frame: Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours.
The time to peak drug concentration will be obtained directly from the data without interpolation
Time to Last Quantifiable Plasma Concentration (Tlast)
Time frame: Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours.
The time to the last quantifiable drug concentration will be obtained directly from the data without interpolation.
Last Quantifiable Plasma Concentration (Clast)
Time frame: Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours.
The concentration of the last quantifiable drug will be obtained directly from the data without interpolation concentration
Elimination Rate Constant (λz)
Time frame: Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours.
The elimination rate constant (λz) will be calculated.
Termination Elimination Half-Life (T1/2)
Time frame: Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours.
The terminal elimination half-life (T1/2) will be calculated.
Area Under the Curve (AUC)
Time frame: Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours.
The AUC from time zero to the time of the last quantifiable concentration (AUClast) will be calculated.
Area Under the Curve to Infinity (AUCinf)
Time frame: Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours.
The AUC from time zero extrapolated to infinity (AUCinf) will be calculate.
Percent Extrapolated of Area Under the Curve to Infinity (AUCextrap[%]).
Time frame: Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours.
The percentage of AUCinf based on extrapolation (AUCextrap[%]).
Oral Clearance (Cl/F)
Time frame: Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours.
The apparent oral clearance will be calculated.
Volume of Distribution (Vz/F)
Time frame: Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours.
Vz/F, apparent volume of distribution will be calculated.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
George J Atiee, MD principal investigator
Worldwide Clinical Trials
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 50 mg PTI-125, 100 mg PTI-125 and 200 mg PTI-125 in people with Alzheimer Disease, Early Onset and Alzheimer Disease, run by Pain Therapeutics at 1 site in United States.
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 9 inclusion and 13 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 10 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Maximum Plasma Concentration (Cmax) (time frame: Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours.). The study lists 11 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 10 May 2021.