Parkinson DiseasePhase 1NCT03093389
Tolerability and Steady-state Pharmacokinetics of BIA 6-512
A Phase 1 study testing BIA 6-512 in people with Parkinson Disease, run by Bial - Portela C S.A. at 1 site in Portugal.
Trial summary
To investigate the tolerability and safety of four multiple-dose regimens of BIA 6-512 (25 mg, 50 mg, 100 mg, and 150 mg 6 times daily) in healthy volunteers and to characterise the steady-state pharmacokinetic profiles of BIA 6-512 (25 mg, 50 mg, 100 mg, and 150 mg 6 times daily) 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
- Parkinson Disease
- What is being tested?
- BIA 6-512
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 sitePortugal
- Study dates
- 11 May 2005to 29 Jul 2005
- Phase
- Phase 1
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female subjects aged between 18 and 45 years, inclusive.
- Subjects of body mass index (BMI) between 19 and 30 kg/m2, inclusive.
- Subjects who were healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG.
- Subjects who had clinical laboratory test results clinically acceptable at screening and admission.
- Subjects who had negative tests for HBsAg, anti-HCVAb and HIV-1 and HIV-2 Ab at screening.
- Subjects who had a negative screen for alcohol and drugs of abuse at screening and admission.
Show all 10Show fewer
- Subjects who were non-smokers or who smoke ≤ 10 cigarettes or equivalent per day.
- Subjects who were able and willing to give written informed consent.
- (If female) She was not of childbearing potential by reason of surgery or, if of childbearing potential, she used one of the following methods of contraception: double barrier, intrauterine device or abstinence.
- (If female) She had a negative urine pregnancy test at screening and admission.
Who cannot join
- Subjects who did not conform to the above inclusion criteria, or
- Subjects who had a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders.
- Subjects who had a clinically relevant surgical history.
- Subjects who had a clinically relevant family history.
- Subjects who had a history of relevant drug or food hypersensitivity.
- Subjects who had a history of alcoholism or drug abuse.
Show all 18Show fewer
- Subjects who consumed more than 21 units of alcohol a week.
- Subjects who had a significant infection or known inflammatory process on screening or admission.
- Subjects who had acute gastrointestinal symptoms at the time of screening or admission (e.g., nausea, vomiting, diarrhoea, heartburn).
- Subjects who had used medicines within 2 weeks of first admission that, in the opinion of the investigator, may affect the safety or other study assessments.
- Subjects who had used any investigational drug or participated in any clinical trial within 2 months of their admission.
- Subjects who had donated or received any blood or blood products within the previous 2 months prior to screening.
- Subjects who were vegetarians, vegans or have medical dietary restrictions.
- Subjects who cannot communicate reliably with the investigator.
- Subjects who were unlikely to co-operate with the requirements of the study.
- Subjects who were unwilling or unable to give written informed consent.
- (If female) She was pregnant or breast-feeding.
- (If female) She was of childbearing potential and she did not use an approved effective contraceptive method (double-barrier, intra-uterine device or abstinence) or she used oral contraceptives.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Human Pharmacology Unit (UFH) - BIAL - Portela & Cª, SA
S. Mamede Do Coronado, 4745-457
About this study
Official title: A Double-blind, Randomised, Placebo-controlled, Rising Multiple-dose Study to Investigate the Tolerability and Steady-state Pharmacokinetics of BIA 6-512 (Trans-resveratrol) in Healthy Volunteers
To investigate the tolerability and safety of four multiple-dose regimens of BIA 6-512 (25 mg, 50 mg, 100 mg, and 150 mg 6 times daily) in healthy volunteers and to characterise the steady-state pharmacokinetic profiles of BIA 6-512 (25 mg, 50 mg, 100 mg, and 150 mg 6 times daily) in healthy volunteers.
Read the detailed description
Single-centre, double-blind, randomised, placebo-controlled study of four multiple-rising doses in four sequential groups of 10 healthy volunteers each. Eligible subjects were admitted to the UFH on the day (Day 0) prior to receiving the first dose of study medication. On the morning of the next day (Day 1), subjects started receiving BIA 6-512/Placebo at 4 h intervals (6 times/day) for 48 h (13 investigational product administrations, in total). Subjects remained confined in the UFH from admission (Day 0) until at least 24 h post last dose (Day 4); then, they were discharged and were requested to return for the follow-up visit. At given time-points, subjects were submitted to vital signs recording, brief neurological examination, and 12-lead ECG. Blood samples for plasma drug assays were taken at the following times: Dose 1: pre-dose and ¼, ½, ¾, 1, 1½, 2, and 3 hours post-dose; Doses 2, 3, 4, 5, 7, 8, 9, 10, 11: pre-dose; Dose 13: pre-dose and ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose.
- Conditions
- Parkinson Disease
- Being tested
- BIA 6-512, Placebo
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIA 6-512Drug
Also called Trans-resveratrol
The investigational products consisted of capsules containing BIA 6-512 25 mg, 50 mg, 100 mg and 150 mg. Products were administered orally, with approximately 240 mL of water in case of Doses 1 and 13, and at least 150 mL of water in case of Doses 2 to 12. First dose (Dose 1) and last dose (Dose 13) were administered in fasting of at least 8 hours and subject remained fasted until to 2.5 h post-dose. Meals were not served within 1 hour prior and 1 hour after investigational product administration in Doses 2 to 12
PlaceboDrug
Matching placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| BIA 6-512 25 mg or Placebo | Experimental | 1 capsule of BIA 6-512 25 mg or 1 capsule of placebo. Receives: Drug: BIA 6-512; Drug: Placebo |
| BIA 6-512 50 mg or Placebo | Experimental | 1 capsule of BIA 6-512 50 mg or 1 capsule of placebo. Receives: Drug: BIA 6-512; Drug: Placebo |
| BIA 6-512 100 mg or Placebo | Experimental | 1 capsule of BIA 6-512 100 mg or 1 capsule of placebo. Receives: Drug: BIA 6-512; Drug: Placebo |
| BIA 6-512 150 mg or Placebo | Experimental | 1 capsule of BIA 6-512 150 mg or 1 capsule of placebo. Receives: Drug: BIA 6-512; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax - the maximum plasma concentration - first dose (dose 1)
BIA 6-512 pharmacokinetic parameters following the first dose (Dose 1)
Measured: Dose 1: pre-dose and ¼, ½, ¾, 1, 1½, 2, and 3 hours post-dose
tmax - the time of occurrence of Cmax - first dose (dose 1)
BIA 6-512 pharmacokinetic parameters following the first dose (Dose 1)
Measured: Dose 1: pre-dose and ¼, ½, ¾, 1, 1½, 2, and 3 hours post-dose
AUC0-t - the area under the plasma concentration-time curve from time zero to the last sampling time at which concentrations are at or above the limit of quantification, calculated by the linear trapezoidal rule - first dose (dose 1)
BIA 6-512 pharmacokinetic parameters following the first dose (Dose 1)
Measured: Dose 1: pre-dose and ¼, ½, ¾, 1, 1½, 2, and 3 hours post-dose
AUC0-τ - the area under the plasma concentration versus time curve over the dosing interval (4 h), calculated by the linear trapezoidal rule - first dose (dose 1)
BIA 6-512 pharmacokinetic parameters following the first dose (Dose 1)
Measured: Dose 1: pre-dose and ¼, ½, ¾, 1, 1½, 2, and 3 hours post-dose
AUC0-¥ - the area under the plasma concentration versus time curve from time zero to infinity, calculated from AUC0-t + (Clast/lz), where Clast is the last quantifiable concentration and lz the apparent terminal rate constant - first dose (dose 1)
BIA 6-512 pharmacokinetic parameters following the first dose (Dose 1)
Measured: Dose 1: pre-dose and ¼, ½, ¾, 1, 1½, 2, and 3 hours post-dose
t½ - the apparent elimination half-life, calculated from ln 2/lz - first dose (dose 1)
BIA 6-512 pharmacokinetic parameters following the first dose (Dose 1)
Measured: Dose 1: pre-dose and ¼, ½, ¾, 1, 1½, 2, and 3 hours post-dose
Cmax - the maximum plasma concentration - last dose (dose 13)
BIA 6-512 pharmacokinetic parameters following the last dose (Dose 13)
Measured: Dose 13: pre-dose and ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose
tmax - the time of occurrence of Cmax - last dose (dose 13)
BIA 6-512 pharmacokinetic parameters following the last dose (Dose 13)
Measured: Dose 13: pre-dose and ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose
AUC0-t - the area under the plasma concentration-time curve from time zero to the last sampling time at which concentrations are at or above the limit of quantification, calculated by the linear trapezoidal rule - last dose (dose 13)
BIA 6-512 pharmacokinetic parameters following the last dose (Dose 13)
Measured: Dose 13: pre-dose and ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose
AUC0-τ - the area under the plasma concentration versus time curve over the dosing interval (4 h), calculated by the linear trapezoidal rule - last dose (dose 13)
BIA 6-512 pharmacokinetic parameters following the last dose (Dose 13)
Measured: Dose 13: pre-dose and ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose
AUC0-¥ - the area under the plasma concentration versus time curve from time zero to infinity, calculated from AUC0-t + (Clast/lz), where Clast is the last quantifiable concentration and lz the apparent terminal rate constant - last dose (dose 13)
BIA 6-512 pharmacokinetic parameters following the last dose (Dose 13)
Measured: Dose 13: pre-dose and ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose
t½ - the apparent elimination half-life, calculated from ln 2/lz - last dose (dose 13)
BIA 6-512 pharmacokinetic parameters following the last dose (Dose 13)
Measured: Dose 13: pre-dose and ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2017
- Study start11 May 2005
- Primary completion29 Jul 2005
- Study completion29 Jul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bial - Portela C S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03093389
- Sponsor's protocol ID
- BIA-6512-103
- Status last verified
- Mar 2017
- First submitted
- 22 Mar 2017
- Last updated
- 28 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomised, Placebo-controlled, Rising Multiple-dose Study to Investigate the Tolerability and Steady-state Pharmacokinetics of BIA 6-512 (Trans-resveratrol) in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03093389
- Acronym / sponsor ID
- BIA-6512-103
- Conditions
- Parkinson Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Bial - Portela C S.A.Industry (pharma, biotech, devices)
- Study start
- 11 May 2005 (actual)
- Primary completion
- 29 Jul 2005 (actual)
- Study completion
- 29 Jul 2005 (actual)
- First posted
- 28 Mar 2017 (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.
To investigate the tolerability and safety of four multiple-dose regimens of BIA 6-512 (25 mg, 50 mg, 100 mg, and 150 mg 6 times daily) in healthy volunteers and to characterise the steady-state pharmacokinetic profiles of BIA 6-512 (25 mg, 50 mg, 100 mg, and 150 mg 6 times daily) in healthy volunteers.
Detailed description
Single-centre, double-blind, randomised, placebo-controlled study of four multiple-rising doses in four sequential groups of 10 healthy volunteers each. Eligible subjects were admitted to the UFH on the day (Day 0) prior to receiving the first dose of study medication. On the morning of the next day (Day 1), subjects started receiving BIA 6-512/Placebo at 4 h intervals (6 times/day) for 48 h (13 investigational product administrations, in total). Subjects remained confined in the UFH from admission (Day 0) until at least 24 h post last dose (Day 4); then, they were discharged and were requested to return for the follow-up visit. At given time-points, subjects were submitted to vital signs recording, brief neurological examination, and 12-lead ECG. Blood samples for plasma drug assays were taken at the following times: Dose 1: pre-dose and ¼, ½, ¾, 1, 1½, 2, and 3 hours post-dose; Doses 2, 3, 4, 5, 7, 8, 9, 10, 11: pre-dose; Dose 13: pre-dose and ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BIA 6-512 25 mg or Placebo | Experimental | Drug: BIA 6-512, Drug: Placebo1 capsule of BIA 6-512 25 mg or 1 capsule of placebo. |
| BIA 6-512 50 mg or Placebo | Experimental | Drug: BIA 6-512, Drug: Placebo1 capsule of BIA 6-512 50 mg or 1 capsule of placebo. |
| BIA 6-512 100 mg or Placebo | Experimental | Drug: BIA 6-512, Drug: Placebo1 capsule of BIA 6-512 100 mg or 1 capsule of placebo. |
| BIA 6-512 150 mg or Placebo | Experimental | Drug: BIA 6-512, Drug: Placebo1 capsule of BIA 6-512 150 mg or 1 capsule of placebo. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Male or female subjects aged between 18 and 45 years, inclusive.
- Subjects of body mass index (BMI) between 19 and 30 kg/m2, inclusive.
- Subjects who were healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG.
- Subjects who had clinical laboratory test results clinically acceptable at screening and admission.
- Subjects who had negative tests for HBsAg, anti-HCVAb and HIV-1 and HIV-2 Ab at screening.
Key exclusion criteria (18 listed)
- Subjects who did not conform to the above inclusion criteria, or
- Subjects who had a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders.
- Subjects who had a clinically relevant surgical history.
- Subjects who had a clinically relevant family history.
- Subjects who had a history of relevant drug or food hypersensitivity.
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 |
|---|---|---|
| BIA 6-512Also: Trans-resveratrolThe investigational products consisted of capsules containing BIA 6-512 25 mg, 50 mg, 100 mg and 150 mg. Products were administered orally, with approximately 240 mL of water in case of Doses 1 and 13, and at least 150 mL of water in case of Doses 2 to 12. First dose (Dose 1) and last dose (Dose 13) were administered in fasting of at least 8 hours and subject remained fasted until to 2.5 h post-dose. Meals were not served within 1 hour prior and 1 hour after investigational product administration in Doses 2 to 12 | Drug | BIA 6-512 100 mg or Placebo, BIA 6-512 150 mg or Placebo, BIA 6-512 25 mg or Placebo, BIA 6-512 50 mg or Placebo |
| PlaceboMatching placebo capsules | Drug | BIA 6-512 100 mg or Placebo, BIA 6-512 150 mg or Placebo, BIA 6-512 25 mg or Placebo, BIA 6-512 50 mg or Placebo |
Primary outcome
Cmax - the maximum plasma concentration - first dose (dose 1)
Time frame: Dose 1: pre-dose and ¼, ½, ¾, 1, 1½, 2, and 3 hours post-dose
BIA 6-512 pharmacokinetic parameters following the first dose (Dose 1)
tmax - the time of occurrence of Cmax - first dose (dose 1)
Time frame: Dose 1: pre-dose and ¼, ½, ¾, 1, 1½, 2, and 3 hours post-dose
BIA 6-512 pharmacokinetic parameters following the first dose (Dose 1)
AUC0-t - the area under the plasma concentration-time curve from time zero to the last sampling time at which concentrations are at or above the limit of quantification, calculated by the linear trapezoidal rule - first dose (dose 1)
Time frame: Dose 1: pre-dose and ¼, ½, ¾, 1, 1½, 2, and 3 hours post-dose
BIA 6-512 pharmacokinetic parameters following the first dose (Dose 1)
AUC0-τ - the area under the plasma concentration versus time curve over the dosing interval (4 h), calculated by the linear trapezoidal rule - first dose (dose 1)
Time frame: Dose 1: pre-dose and ¼, ½, ¾, 1, 1½, 2, and 3 hours post-dose
BIA 6-512 pharmacokinetic parameters following the first dose (Dose 1)
AUC0-¥ - the area under the plasma concentration versus time curve from time zero to infinity, calculated from AUC0-t + (Clast/lz), where Clast is the last quantifiable concentration and lz the apparent terminal rate constant - first dose (dose 1)
Time frame: Dose 1: pre-dose and ¼, ½, ¾, 1, 1½, 2, and 3 hours post-dose
BIA 6-512 pharmacokinetic parameters following the first dose (Dose 1)
t½ - the apparent elimination half-life, calculated from ln 2/lz - first dose (dose 1)
Time frame: Dose 1: pre-dose and ¼, ½, ¾, 1, 1½, 2, and 3 hours post-dose
BIA 6-512 pharmacokinetic parameters following the first dose (Dose 1)
Cmax - the maximum plasma concentration - last dose (dose 13)
Time frame: Dose 13: pre-dose and ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose
BIA 6-512 pharmacokinetic parameters following the last dose (Dose 13)
tmax - the time of occurrence of Cmax - last dose (dose 13)
Time frame: Dose 13: pre-dose and ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose
BIA 6-512 pharmacokinetic parameters following the last dose (Dose 13)
AUC0-t - the area under the plasma concentration-time curve from time zero to the last sampling time at which concentrations are at or above the limit of quantification, calculated by the linear trapezoidal rule - last dose (dose 13)
Time frame: Dose 13: pre-dose and ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose
BIA 6-512 pharmacokinetic parameters following the last dose (Dose 13)
AUC0-τ - the area under the plasma concentration versus time curve over the dosing interval (4 h), calculated by the linear trapezoidal rule - last dose (dose 13)
Time frame: Dose 13: pre-dose and ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose
BIA 6-512 pharmacokinetic parameters following the last dose (Dose 13)
AUC0-¥ - the area under the plasma concentration versus time curve from time zero to infinity, calculated from AUC0-t + (Clast/lz), where Clast is the last quantifiable concentration and lz the apparent terminal rate constant - last dose (dose 13)
Time frame: Dose 13: pre-dose and ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose
BIA 6-512 pharmacokinetic parameters following the last dose (Dose 13)
t½ - the apparent elimination half-life, calculated from ln 2/lz - last dose (dose 13)
Time frame: Dose 13: pre-dose and ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose
BIA 6-512 pharmacokinetic parameters following the last dose (Dose 13)
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 28 Mar 2017.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 BIA 6-512 in people with Parkinson Disease, run by Bial - Portela C S.A. at 1 site in Portugal.
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 10 inclusion and 18 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 28 Mar 2017. 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 Portugal. 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. 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?
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?
Cmax - the maximum plasma concentration - first dose (dose 1) (time frame: Dose 1: pre-dose and ¼, ½, ¾, 1, 1½, 2, and 3 hours post-dose). The study lists 12 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 28 Mar 2017.