Multiple SclerosisPhase 1ARN-6039NCT03237832
A Phase 1 Study of ARN-6039
A Phase 1 study testing ARN-6039 in people with Multiple Sclerosis, run by Arrien Pharmaceuticals.
Trial summary
This Phase 1 study intends to determine the safety and tolerability of ARN-6039 in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- ARN-6039
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 16 May 2016to Feb 2017
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Only volunteers who met all of the following criteria were included as study subjects:
- Male or female between 18 and 50 years of age, inclusive.
- Female subjects were not pregnant or lactating.
- Female subjects were postmenopausal (at least 2 years prior to dosing) or surgically sterile. Subjects who claimed postmenopausal status had their status confirmed with a follicle-stimulating hormone (FSH) test. Surgically sterile was defined as: Bilateral tubal ligation, hysterectomy, or bilateral oophorectomy at least 6 months prior to dosing; or Permanent sterilization (e.g., ESSURE procedure) at least 3 months prior to dosing.
- Subjects had a body mass index (BMI) between 19 and 30 kg/m2 (inclusive) and weighed a minimum of 50 kg (110 lbs).
- Subjects voluntarily consented to participate in this study and provided their written informed consent prior to start of any study-specific procedures.
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- Subject was willing and able to comply with all trial requirements.
- Subject was willing and able to remain in the study unit for the entire duration of the confinement period and return for an outpatient visit 7 days after study treatment administration.
- Subject's vital signs (measured sitting after 5 minutes rest) at screening were within the following ranges: heart rate: 40-100 beats per minute [bpm]; systolic blood pressure (BP): 90-145 mmHg; diastolic BP: 50-95 mmHg. Out-of-range vital signs could be repeated once. Predose vital signs were assessed by the Principal Investigator or designee (e.g., a medically qualified Sub-Investigator) prior to study drug administration. The Principal Investigator or designee verified the eligibility of each subject with out-of-range vital signs and documented approval prior to dosing.
- Subjects had results within normal range on the following hematology tests performed at screening: hemoglobin, hematocrit, total and differential leukocyte count, and platelet count.
- Subject had results that did not exceed the upper limit of normal range on the following liver function tests performed at screening: aspartate transaminase (AST), alanine transaminase (ALT), and total bilirubin.
- If enrolled in Cohort 5 (the food-effect cohort), subject was willing and able to consume the entire high-calorie, high-fat breakfast meal in the designated timeframe required during the fed period.
Who cannot join
- Volunteers who presented any of the following criteria were excluded as study subjects:
- History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal (including cholecystectomy), endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease or any other condition that, in the opinion of the Investigator, would likely have interfered with the absorption, disposition, metabolism, or excretion of the investigational product, or would have jeopardized the safety of the subject or the validity of the study results.
- History of cancer with the exception of basal cell carcinoma or squamous cell (skin) carcinoma.
- History of seizure (including febrile seizure) or loss of consciousness.
- History of drug or alcohol abuse or dependence (based on the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition criteria) within the past 2 years.
- Donated blood or plasma or experienced significant loss of blood within 8 weeks prior to admission to the clinic, or planned to donate blood within 1 month after study participation.
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- Had a clinically significant abnormal finding on the physical exam, medical history, ECG, or clinical laboratory results at screening.
- Had smoked or used tobacco or nicotine-containing products (e.g., cigarettes, cigars, chewing tobacco, snuff, etc.) within 30 days prior to the first dose of study medication.
- History or presence of allergic or adverse response to ARN-6039 or related drugs or its excipients.
- Had been on a significantly abnormal diet during the 4 weeks preceding the first dose of study medication.
- Had participated in another clinical trial (randomized subjects only) within 30 days (or 5 half-lives of the investigational product) prior to the first dose of study medication.
- Had used any over-the-counter (OTC) medication, nutritional or dietary supplements, or herbal preparations, (other than acetaminophen and/or multivitamins [acetaminophen 2 grams/day and multivitamins were allowed up to 48 hours prior to dosing]), within 7 days prior to the first dose of medication.
- Had used any prescription medication, except hormonal replacement therapy, within 14 days prior to the first dose of study medication.
- Consumed the following beverages or products within the specified time frame prior to admission to the clinic: Alcohol, grapefruit, Seville oranges (marmalade), xanthine, or quinine within 72 hours; or Caffeine or poppy seeds within 48 hours.
- Had been treated with any known drugs that are moderate or strong inhibitors/inducers of cytochrome P450 (CYP) enzymes such as barbiturates, phenothiazines, cimetidine, carbamazepine, etc., within 30 days prior to the first dose of study medication and that in the Investigator's judgment may have impacted subject safety or the validity of the study results.
- Had a positive urine screen for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cocaine, cannabinoids, opiates) or cotinine.
- Had a positive test for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV) at screening or had been previously treated for hepatitis B, hepatitis C, or HIV infection.
- Was, for any reason, deemed by the investigator to be inappropriate for this study, including subjects who were unable to communicate or cooperate with the investigator or designee.
- Female with a positive pregnancy test result.
About this study
Official title: A Phase 1, Single-Center, Randomized, Double-Blind, Placebo-Controlled Safety, Tolerability, and Pharmacokinetic Study of Single Ascending Oral Doses of ARN-6039 in Healthy Adult Subjects.
This Phase 1 study intends to determine the safety and tolerability of ARN-6039 in healthy subjects.
Read the detailed description
To determine the safety and tolerability in healthy subjects, ARN-6039 will be dosed in a single-center, randomized, double-blind, placebo-controlled, ascending dose study. Five cohorts of 10 subjects will be dosed in ascending order, beginning with a single dose of 50 mg of ARN-6039. Subsequent cohorts will be administered single doses of 100 mg, 150 mg, 200 mg, or 300 mg. Safety, tolerability, and pharmacokinetics will be evaluated prior to each dose escalation using the assessment of all available safety and pharmacokinetic data.
In Cohorts 1 through 4, subjects will receive a single dose of ARN-6039 or matching placebo under fasted conditions. In Cohort 5, subjects will be administered a single dose of ARN-6039 or a single dose of matching placebo under fasted conditions in Period 1 and under fed conditions in Period 2 with a minimum 5-day washout period between each dose.
To support the administration of ARN-6039 in humans, preclinical toxicology studies performed in rats and dogs demonstrated tolerability exceeding the intended therapeutic dose. In addition, the safety and efficacy of ARN-6039 has been demonstrated in model systems and is anticipated to be well tolerated in humans. This study will be the first administration of ARN-6039 in human subjects.
- Conditions
- Multiple Sclerosis
- Being tested
- ARN-6039, Placebo
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARN-6039Drug
Ascending doses per Cohort
PlaceboOther
Placebo to match ARN-6039
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Placebo comparator | Cohort 1 (sentinel group): 1 subject received 50 mg ARN-6039 and 1 subject placebo Cohort 1: 7 subjects received 50 mg ARN-6039 and 1 subject placebo Receives: Drug: ARN-6039; Other: Placebo |
| Cohort 2 | Placebo comparator | Cohort 2 (sentinel group): 1 subject received 100 mg ARN-6039 and 1 subject placebo Cohort 2: 7 subjects received 100 mg ARN-6039 and 1 subject placebo Receives: Drug: ARN-6039; Other: Placebo |
| Cohort 3 | Placebo comparator | Cohort 3 (sentinel group): 1 subject received 150 mg ARN-6039 and 1 subject placebo Cohort 3: 7 subjects received 150 mg ARN-6039 and 1 subject placebo Receives: Drug: ARN-6039; Other: Placebo |
| Cohort 4 | Placebo comparator | Cohort 4 (sentinel group): 1 subject received 200 mg ARN-6039 and 1 subject placebo Cohort : 7 subjects received 200 mg ARN-6039 and 1 subject placebo Receives: Drug: ARN-6039; Other: Placebo |
| Cohort 5 | Placebo comparator | Cohort 5 Period 1, fasted (sentinel group): 1 subject received 300 mg ARN-6039 and 1 subject placebo Cohort 5 Period 1, fasted: 7 subjects received 300 mg ARN-6039 and 1 subject placebo Cohort 5 Period 2, fed (sentinel group): 1 subject received 300 mg ARN-6039 and 1 subject placebo Cohort 5 Period 2, fed: 7 subjects received 300 mg ARN-6039 and 1 subject placebo Receives: Drug: ARN-6039; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in clinical tests results over time
Assess the results of analytical hematology, serology, and urine tests compared to normal results from baseline to 7 days post administration
Measured: Days -1, 1, 2, 3, and 7
Change in vital signs over time
Assess subject vital signs compared to normal results from baseline to 7 days post administration
Measured: Days -1, 1, 2, 3, and 7
Change in physical assessment over time
Assess results of subject physical examination compared to normal results from baseline to 7 days post administration
Measured: Days -1, 1, 2, 3, and 7
Change in electrocardiograms (ECGs) over time
Assess results of subject electrocardiograms compared to normal from baseline to 7 days post administration
Measured: Days -1, 1, 2, 3, and 7
Determine the incidence of Treatment Adverse Events (AEs) over time
Assess any adverse events compared to normal from baseline to 7 days post administration
Measured: Days -1, 1, 2, 3, and 7
Secondary outcomes (6)
Assay maximum plasma concentration (Cmax) over time
Assess the results of the maximum plasma concentration (Cmax) over time in both the unfed and fed state
Measured: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36 and 48 hours after dosing
Assay the time to Cmax (tmax) over time
Assess the results of the assay time to Cmax (tmax) over time in both the unfed and fed state
Measured: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36 and 48 hours after dosing
Assay the area under the plasma concentration time curve from zero to the last measurable concentration (AUC0-t) over time
Assess the results of the assay of the area under the plasma concentration time curve from zero to the last measurable concentration (AUC0-t) over time in both the unfed and fed state
Measured: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36 and 48 hours after dosing
Assay the terminal half-life (t1/2) over time
Assess the results of the assay the terminal half-life (t1/2) over time in both the unfed and fed state
Measured: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36 and 48 hours after dosing
Assay the area under the plasma concentration time curve from zero to infinity (AUC0-inf) over time
Assess the results of the area under the plasma concentration time curve from zero to infinity (AUC0-inf) over time in both the unfed and fed state
Measured: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36 and 48 hours after dosing
Assay the apparent oral clearance (CL/F) over time
Assess the results of the apparent oral clearance (CL/F) over time in both the unfed and fed state
Measured: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36 and 48 hours after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2017
- Study start16 May 2016
- Primary completion6 Oct 2016
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Determine safety and tolerability of ARN-6039 ascending doses compared to placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arrien Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Worldwide Clinical Trials
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03237832
- Sponsor's protocol ID
- ARN-CLN-0001
- Acronym
- ARN-6039
- Status last verified
- Aug 2017
- First submitted
- 21 Jul 2017
- Last updated
- 3 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: This is a single-center, randomized, ascending dose study in which 5 cohorts of healthy male and female subjects will be administered single doses of ARN 6039 or matching placebo; subjects will be blinded to treatment (ARN-6039 vs. placebo). The ARN 6039 dose will be escalated in each cohort. Each individual participant data is available from sponsor company for review.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-Center, Randomized, Double-Blind, Placebo-Controlled Safety, Tolerability, and Pharmacokinetic Study of Single Ascending Oral Doses of ARN-6039 in Healthy Adult Subjects.
- ClinicalTrials.gov ID
- NCT03237832
- Acronym / sponsor ID
- ARN-6039 / ARN-CLN-0001
- Conditions
- Multiple Sclerosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Arrien PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Worldwide Clinical Trials
- Study start
- 16 May 2016 (actual)
- Primary completion
- 6 Oct 2016 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 3 Aug 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.
This Phase 1 study intends to determine the safety and tolerability of ARN-6039 in healthy subjects.
Detailed description
To determine the safety and tolerability in healthy subjects, ARN-6039 will be dosed in a single-center, randomized, double-blind, placebo-controlled, ascending dose study. Five cohorts of 10 subjects will be dosed in ascending order, beginning with a single dose of 50 mg of ARN-6039. Subsequent cohorts will be administered single doses of 100 mg, 150 mg, 200 mg, or 300 mg. Safety, tolerability, and pharmacokinetics will be evaluated prior to each dose escalation using the assessment of all available safety and pharmacokinetic data.
In Cohorts 1 through 4, subjects will receive a single dose of ARN-6039 or matching placebo under fasted conditions. In Cohort 5, subjects will be administered a single dose of ARN-6039 or a single dose of matching placebo under fasted conditions in Period 1 and under fed conditions in Period 2 with a minimum 5-day washout period between each dose.
To support the administration of ARN-6039 in humans, preclinical toxicology studies performed in rats and dogs demonstrated tolerability exceeding the intended therapeutic dose. In addition, the safety and efficacy of ARN-6039 has been demonstrated in model systems and is anticipated to be well tolerated in humans. This study will be the first administration of ARN-6039 in human subjects.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- Determine safety and tolerability of ARN-6039 ascending doses compared to placebo
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Placebo comparator | Drug: ARN-6039, Other: PlaceboCohort 1 (sentinel group): 1 subject received 50 mg ARN-6039 and 1 subject placebo Cohort 1: 7 subjects received 50 mg ARN-6039 and 1 subject placebo |
| Cohort 2 | Placebo comparator | Drug: ARN-6039, Other: PlaceboCohort 2 (sentinel group): 1 subject received 100 mg ARN-6039 and 1 subject placebo Cohort 2: 7 subjects received 100 mg ARN-6039 and 1 subject placebo |
| Cohort 3 | Placebo comparator | Drug: ARN-6039, Other: PlaceboCohort 3 (sentinel group): 1 subject received 150 mg ARN-6039 and 1 subject placebo Cohort 3: 7 subjects received 150 mg ARN-6039 and 1 subject placebo |
| Cohort 4 | Placebo comparator | Drug: ARN-6039, Other: PlaceboCohort 4 (sentinel group): 1 subject received 200 mg ARN-6039 and 1 subject placebo Cohort : 7 subjects received 200 mg ARN-6039 and 1 subject placebo |
| Cohort 5 | Placebo comparator | Drug: ARN-6039, Other: PlaceboCohort 5 Period 1, fasted (sentinel group): 1 subject received 300 mg ARN-6039 and 1 subject placebo Cohort 5 Period 1, fasted: 7 subjects received 300 mg ARN-6039 and 1 subject placebo Cohort 5 Period 2, fed (sentinel group): 1 subject received 300 mg ARN-6039 and 1 subject placebo Cohort 5 Period 2, fed: 7 subjects received 300 mg ARN-6039 and 1 subject placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Male or female between 18 and 50 years of age, inclusive.
- Female subjects were not pregnant or lactating.
- Female subjects were postmenopausal (at least 2 years prior to dosing) or surgically sterile. Subjects who claimed postmenopausal status had their status confirmed with a follicle-stimulating hormone (FSH) test. Surgically sterile was defined as: Bilateral tubal ligation, hysterectomy, or bilateral oophorectomy at least 6 months prior to dosing; or Permanent sterilization (e.g., ESSURE procedure) at least 3 months prior to dosing.
- Subjects had a body mass index (BMI) between 19 and 30 kg/m2 (inclusive) and weighed a minimum of 50 kg (110 lbs).
- Subjects voluntarily consented to participate in this study and provided their written informed consent prior to start of any study-specific procedures.
Key exclusion criteria (19 listed)
- History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal (including cholecystectomy), endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease or any other condition that, in the opinion of the Investigator, would likely have interfered with the absorption, disposition, metabolism, or excretion of the investigational product, or would have jeopardized the safety of the subject or the validity of the study results.
- History of cancer with the exception of basal cell carcinoma or squamous cell (skin) carcinoma.
- History of seizure (including febrile seizure) or loss of consciousness.
- History of drug or alcohol abuse or dependence (based on the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition criteria) within the past 2 years.
- Donated blood or plasma or experienced significant loss of blood within 8 weeks prior to admission to the clinic, or planned to donate blood within 1 month after study participation.
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 |
|---|---|---|
| ARN-6039Ascending doses per Cohort | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5 |
| PlaceboPlacebo to match ARN-6039 | Other | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5 |
Primary outcome
Change in clinical tests results over time
Time frame: Days -1, 1, 2, 3, and 7
Assess the results of analytical hematology, serology, and urine tests compared to normal results from baseline to 7 days post administration
Change in vital signs over time
Time frame: Days -1, 1, 2, 3, and 7
Assess subject vital signs compared to normal results from baseline to 7 days post administration
Change in physical assessment over time
Time frame: Days -1, 1, 2, 3, and 7
Assess results of subject physical examination compared to normal results from baseline to 7 days post administration
Change in electrocardiograms (ECGs) over time
Time frame: Days -1, 1, 2, 3, and 7
Assess results of subject electrocardiograms compared to normal from baseline to 7 days post administration
Determine the incidence of Treatment Adverse Events (AEs) over time
Time frame: Days -1, 1, 2, 3, and 7
Assess any adverse events compared to normal from baseline to 7 days post administration
6 secondary outcomes
Assay maximum plasma concentration (Cmax) over time
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36 and 48 hours after dosing
Assay the time to Cmax (tmax) over time
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36 and 48 hours after dosing
Assay the area under the plasma concentration time curve from zero to the last measurable concentration (AUC0-t) over time
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36 and 48 hours after dosing
Assay the terminal half-life (t1/2) over time
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36 and 48 hours after dosing
Assay the area under the plasma concentration time curve from zero to infinity (AUC0-inf) over time
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36 and 48 hours after dosing
Assay the apparent oral clearance (CL/F) over time
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36 and 48 hours after dosing
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 3 Aug 2017.
- Individual participant dataSharing planned: Yes. This is a single-center, randomized, ascending dose study in which 5 cohorts of healthy male and female subjects will be administered single doses of ARN 6039 or matching placebo; subjects will be blinded to treatment (ARN-6039 vs. placebo). The ARN 6039 dose will be escalated in each cohort. Each individual participant data is available from sponsor company for review.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ARN-6039 in people with Multiple Sclerosis, run by Arrien Pharmaceuticals.
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 12 inclusion and 19 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 3 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Change in clinical tests results over time (time frame: Days -1, 1, 2, 3, and 7). The study lists 5 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 3 Aug 2017.