ADHDEarly Phase 1NCT03680885
Validating a New Non-invasive Approach to Testing Lidocaine Effectiveness
A Early Phase 1 study testing Lidocaine gel and Injected lidocaine in people with ADHD and Controls, run by PhenoSolve, LLC at 1 site in United States.
Trial summary
This work will assess the reliability of a simple painless test for the effectiveness of the commonly used local anesthetic lidocaine Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- What is being tested?
- Lidocaine gel and Injected lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2019to 30 Mar 2020
- Phase
- Early 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 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Report "get numb at dentist"
- Report "trouble getting numb at dentist"
Who cannot join
- ADHD, ADD, and other inattention disorders
- Known adverse reactions to lidocaine;
- Epilepsy
- IQ <80
- Severe head trauma
- Birth weight <2270 grams
Show all 109Show fewer
- Severe autism
- Generalized anxiety disorders (but dental-specific anxiety will not be an exclusion because many of these individuals may be ones with anxiety because of painful dental experiences with lidocaine ineffectiveness)
- Mouth sores
- Ehlers Danlos syndrome
- Red hair
- Current pregnancy
- Treatment currently with potassium or potassium-elevating drugs such as renin-angiotensin-aldosterone blockers
- Angiotensin Converting Enzyme Inhibitors
- Alacepril (not available in US)
- Benazepril (Lotensin)
- Captopril (trade name Capoten)
- Cilazapril (Inhibace)
- Delapril (not available in US)
- Enalapril (Vasotec/Renitec)
- Fosinopril (Fositen/Monopril)
- Imidapril (Tanatril)
- Lisinopril (Listril/Lopril/Novatec/Prinivil/Zestril)
- Moexipril (Univasc)
- Perindopril (Coversyl/Aceon/Perindo)
- Quinapril (Accupril)
- Ramipril (Altace/Prilace/Ramace/Ramiwin/Triatec/Tritace)
- Spirapril (Renormax)
- Temocapril (not available in US)
- Teprotide (but not active by oral administration and not used in US)
- Trandolapril (Mavik/Odrik/Gopten)
- Zofenopril
- Angiotensin receptor blockers
- Azilsartan (Edarbi)
- Candesartan (Atacand)
- Eprosartan (Teveten)
- Fimasartan (Kanarb)
- Irbesartan (Avapro)
- Losartan (Cozaar)
- Olmesartan (Benicar/Olmetec)
- Telmisartan (Micardis)
- Valsartan (Diovan)
- Aldosterone antagonists
- Spironolactone (Aldactone)
- Eplerenone (Inspra)
- Renin inhibitors - Aliskiren (Tekturna, Rasilez)
- Other potassium elevating agents
- Antibiotics, including penicillin G and trimethoprim
- Azole antifungals
- Beta-blockers
- Herbal supplements, including milkweed, lily of the valley, Siberian ginseng, Hawthorn berries
- Heparin
- Nonsteroidal anti-inflammatory medications (NSAIDs)
- Oral contraceptives containing drospirenone
- Arm 2 Eligibility
- Known adverse reactions to lidocaine;
- Epilepsy
- IQ <80
- Severe head trauma
- Birth weight <2270 grams
- Severe autism
- Generalized anxiety disorders (but dental-specific anxiety will not be an exclusion because many of these individuals may be ones with anxiety because of painful dental experiences with lidocaine ineffectiveness)
- Mouth sores
- Ehlers Danlos syndrome
- Red hair
- Current pregnancy
- Treatment currently with potassium or potassium-elevating drugs such as renin-angiotensin-aldosterone blockers
- Angiotensin Converting Enzyme Inhibitors
- Alacepril (not available in US)
- Benazepril (Lotensin)
- Captopril (trade name Capoten)
- Cilazapril (Inhibace)
- Delapril (not available in US)
- Enalapril (Vasotec/Renitec)
- Fosinopril (Fositen/Monopril)
- Imidapril (Tanatril)
- Lisinopril (Listril/Lopril/Novatec/Prinivil/Zestril)
- Moexipril (Univasc)
- Perindopril (Coversyl/Aceon/Perindo)
- Quinapril (Accupril)
- Ramipril (Altace/Prilace/Ramace/Ramiwin/Triatec/Tritace)
- Spirapril (Renormax)
- Temocapril (not available in US)
- Teprotide (but not active by oral administration and not used in US)
- Trandolapril (Mavik/Odrik/Gopten)
- Zofenopril
- Angiotensin receptor blockers
- Azilsartan (Edarbi)
- Candesartan (Atacand)
- Eprosartan (Teveten)
- Fimasartan (Kanarb)
- Irbesartan (Avapro)
- Losartan (Cozaar)
- Olmesartan (Benicar/Olmetec)
- Telmisartan (Micardis)
- Valsartan (Diovan)
- Aldosterone antagonists
- Spironolactone (Aldactone)
- Eplerenone (Inspra)
- Renin inhibitors
- Aliskiren (Tekturna, Rasilez)
- Other potassium elevating agents
- Antibiotics, including penicillin G and trimethoprim
- Azole antifungals
- Beta-blockers
- Herbal supplements, including milkweed, lily of the valley, Siberian ginseng, Hawthorn berries
- Heparin
- Nonsteroidal anti-inflammatory medications (NSAIDs)
- Oral contraceptives containing drospirenone
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reliability Testing of a Non-invasive, Pain-free, Taste-based Assessment Approach to Lidocaine Effectiveness
This work will assess the reliability of a simple painless test for the effectiveness of the commonly used local anesthetic lidocaine
Read the detailed description
In prior tests with a convenience sample, subjects who reported that they had no trouble getting numb at the dentist, also got numb with lidocaine gel on the surface of the tongue. That numbness prevented them from being able to taste any flavor until the numbness had worn off. Subjects who reported having trouble getting numb at the dentist, could still taste flavors after the application of lidocaine.
This work will assess the reliability of a taste-based approach for creating a non-invasive way to test lidocaine effectiveness. The controlled trial will assess the ability of lidocaine oral gel to block taste (e.g., sweet) in 20 adults (ages 18-49) half with history of trouble getting numb at the dentist (Arm 2) and half with no trouble (Arm 1). To determine reproducibility, the taste-based test will be done 4 times on different days, twice with lidocaine and twice with a placebo, with randomization and double-blinding. These repeated results will be compared to a fifth assessment, against the "gold standard" of injection of lidocaine, assessed using a dental probe.
On each of four separate visits, in randomized order, the subject will be tested with tastants to the tongue twice after application of a lidocaine gel to the tongue and twice with a placebo gel. After a wait of two-minutes, the three tastants will be tested. The subject is blinded to the taste and the identity of the gel, which have been compounded to look the same.
On the fifth (last) visit, the subject will get an oral injection of lidocaine and the numbness assessed.
The results across the five tests will then be analyzed.
We are testing in separate studies NCT 03563573 and NCT 03676725 the prevalence of lidocaine ineffectiveness in those with Attention Deficit Hyperactivity Disorder (ADHD) and in the general population without ADHD. We believe the prevalence will be higher in ADHD. As a result, in this evaluation we have one Arm "gets numb at the dentist" where exclusion criteria includes ADHD and a second Arm "has trouble getting numb at the dentist" that does not have that exclusion.
- Being tested
- Lidocaine gel, Placebo, Injected lidocaine
- Keywords
- Lidocaine ineffectiveness, ADHD, ADD
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine gelDrug
Also called Intervention
Lidocaine gel 5%, PEG with FD\&C Blue No.1 (Brilliant Blue FCF)
PlaceboDrug
Also called Control gel
PEG with FD\&C Blue No.1 (Brilliant Blue FCF)
Injected lidocaineDrug
Also called Current practice
Standard FDA-approved dental injectable lidocaine
| Study group | Role | What they receive |
|---|---|---|
| Reports getting numb at dentist | Active comparator | Subjects will be tested twice with lidocaine gel, twice with a Placebo and once with Injected Lidocaine to assess effectiveness of lidocaine. Each assessment will be on a different day. Receives: Drug: Lidocaine gel; Drug: Placebo; Drug: Injected lidocaine |
| Reports trouble getting numb at dentist | Active comparator | Subjects will be tested twice with lidocaine gel, twice with a Placebo and once with Injected Lidocaine to assess effectiveness of lidocaine. Each assessment will be on a different day. Receives: Drug: Lidocaine gel; Drug: Placebo; Drug: Injected lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Taste sensation after lidocaine or placebo
The subject is blinded to the tastant and gel identities. The 3 tastants are tested in randomized order.
After application of lidocaine gel or placebo to the tongue, and a wait of 2 minutes, the subject's tongue is rubbed with a swab that has been wet with the tastant on the subject's tongue.
The subject is asked to identify the taste (e.g., sweet).
Then, on a 5-point scale (0-4, ranging from none to very intense) they are asked to rate the intensity of the taste.
The process is repeated for each of the three tastants.
The consistency of the subject responses over the 4 sessions will be analyzed.
Measured: 4 visits each of 30 minutes within weeks of one another, average ~1 month total
Ability to feel pressure and discomfort after injection of lidocaine into the cheek
Inject lidocaine as would be done in a dental visit, assess numbness to pressure and discomfort using the Baker Wong FACES scale (0-10) scale of discomfort, ranging from none to intense pain.
The effectiveness of lidocaine will be assessed, and then the results compared to Outcome 1.
Measured: 1 visit of 30 minutes after other 4 visits, average ~1 month total
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2018
- Study start1 Aug 2019
- Primary completion30 Mar 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for ADHDStudies 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
- Early Phase 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Half the subjects will have a self-reported history of lidocaine working for them (effective) and half will have a history of difficulty getting numb (ineffective).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- PhenoSolve, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Jacobi Medical Center
- Responsible party
- Sponsor
- Investigators
- Michael Segal, MD PhD, Principal investigator, PhenoSolve, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03680885
- Sponsor's protocol ID
- 2018-271
- Status last verified
- Jul 2020
- First submitted
- 17 Sep 2018
- Last updated
- 15 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share with the FDA the validation of the taste approach to testing lidocaine effectiveness, as part of an IDE application.
Publications
Infante MA, Moore EM, Nguyen TT, Fourligas N, Mattson SN, Riley EP. Objective assessment of ADHD core symptoms in children with heavy prenatal alcohol exposure. Physiol Behav. 2015 Sep 1;148:45-50. doi: 10.1016/j.physbeh.2014.10.014. Epub 2014 Oct 23.
PubMed 25447751Levitt JO. Practical aspects in the management of hypokalemic periodic paralysis. J Transl Med. 2008 Apr 21;6:18. doi: 10.1186/1479-5876-6-18.
PubMed 18426576Nakai Y, Milgrom P, Mancl L, Coldwell SE, Domoto PK, Ramsay DS. Effectiveness of local anesthesia in pediatric dental practice. J Am Dent Assoc. 2000 Dec;131(12):1699-705. doi: 10.14219/jada.archive.2000.0115.
PubMed 11143733Segal MM. We cannot say whether attention deficit hyperactivity disorder exists, but we can find its molecular mechanisms. Pediatr Neurol. 2014 Jul;51(1):15-6. doi: 10.1016/j.pediatrneurol.2014.04.014. Epub 2014 Apr 18. No abstract available.
PubMed 24938135Segal MM, Rogers GF, Needleman HL, Chapman CA. Hypokalemic sensory overstimulation. J Child Neurol. 2007 Dec;22(12):1408-10. doi: 10.1177/0883073807307095.
PubMed 18174562Segal MM, Douglas AF. Late sodium channel openings underlying epileptiform activity are preferentially diminished by the anticonvulsant phenytoin. J Neurophysiol. 1997 Jun;77(6):3021-34. doi: 10.1152/jn.1997.77.6.3021.
PubMed 9212254Teicher MH, Polcari A, Fourligas N, Vitaliano G, Navalta CP. Hyperactivity persists in male and female adults with ADHD and remains a highly discriminative feature of the disorder: a case-control study. BMC Psychiatry. 2012 Nov 7;12:190. doi: 10.1186/1471-244X-12-190.
PubMed 23134619
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability Testing of a Non-invasive, Pain-free, Taste-based Assessment Approach to Lidocaine Effectiveness
- ClinicalTrials.gov ID
- NCT03680885
- Acronym / sponsor ID
- 2018-271
- Keywords
- Lidocaine ineffectiveness, ADHD, ADD
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- PhenoSolve, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Jacobi Medical Center
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 21 Sep 2018 (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 work will assess the reliability of a simple painless test for the effectiveness of the commonly used local anesthetic lidocaine
Detailed description
In prior tests with a convenience sample, subjects who reported that they had no trouble getting numb at the dentist, also got numb with lidocaine gel on the surface of the tongue. That numbness prevented them from being able to taste any flavor until the numbness had worn off. Subjects who reported having trouble getting numb at the dentist, could still taste flavors after the application of lidocaine.
This work will assess the reliability of a taste-based approach for creating a non-invasive way to test lidocaine effectiveness. The controlled trial will assess the ability of lidocaine oral gel to block taste (e.g., sweet) in 20 adults (ages 18-49) half with history of trouble getting numb at the dentist (Arm 2) and half with no trouble (Arm 1). To determine reproducibility, the taste-based test will be done 4 times on different days, twice with lidocaine and twice with a placebo, with randomization and double-blinding. These repeated results will be compared to a fifth assessment, against the "gold standard" of injection of lidocaine, assessed using a dental probe.
On each of four separate visits, in randomized order, the subject will be tested with tastants to the tongue twice after application of a lidocaine gel to the tongue and twice with a placebo gel. After a wait of two-minutes, the three tastants will be tested. The subject is blinded to the taste and the identity of the gel, which have been compounded to look the same.
On the fifth (last) visit, the subject will get an oral injection of lidocaine and the numbness assessed.
The results across the five tests will then be analyzed.
We are testing in separate studies NCT 03563573 and NCT 03676725 the prevalence of lidocaine ineffectiveness in those with Attention Deficit Hyperactivity Disorder (ADHD) and in the general population without ADHD. We believe the prevalence will be higher in ADHD. As a result, in this evaluation we have one Arm "gets numb at the dentist" where exclusion criteria includes ADHD and a second Arm "has trouble getting numb at the dentist" that does not have that exclusion.
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
- 2
- Model description
- Half the subjects will have a self-reported history of lidocaine working for them (effective) and half will have a history of difficulty getting numb (ineffective).
| Arm | Type | Receives |
|---|---|---|
| Reports getting numb at dentist | Active comparator | Drug: Lidocaine gel, Drug: Placebo, Drug: Injected lidocaineSubjects will be tested twice with lidocaine gel, twice with a Placebo and once with Injected Lidocaine to assess effectiveness of lidocaine. Each assessment will be on a different day. |
| Reports trouble getting numb at dentist | Active comparator | Drug: Lidocaine gel, Drug: Placebo, Drug: Injected lidocaineSubjects will be tested twice with lidocaine gel, twice with a Placebo and once with Injected Lidocaine to assess effectiveness of lidocaine. Each assessment will be on a different day. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Report "get numb at dentist"
- Report "trouble getting numb at dentist"
Key exclusion criteria (109 listed)
- ADHD, ADD, and other inattention disorders
- Known adverse reactions to lidocaine;
- Epilepsy
- IQ <80
- Severe head trauma
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 |
|---|---|---|
| Lidocaine gelAlso: InterventionLidocaine gel 5%, PEG with FD\&C Blue No.1 (Brilliant Blue FCF) | Drug | Reports getting numb at dentist, Reports trouble getting numb at dentist |
| PlaceboAlso: Control gelPEG with FD\&C Blue No.1 (Brilliant Blue FCF) | Drug | Reports getting numb at dentist, Reports trouble getting numb at dentist |
| Injected lidocaineAlso: Current practiceStandard FDA-approved dental injectable lidocaine | Drug | Reports getting numb at dentist, Reports trouble getting numb at dentist |
Primary outcome
Taste sensation after lidocaine or placebo
Time frame: 4 visits each of 30 minutes within weeks of one another, average ~1 month total
The subject is blinded to the tastant and gel identities. The 3 tastants are tested in randomized order. After application of lidocaine gel or placebo to the tongue, and a wait of 2 minutes, the subject's tongue is rubbed with a swab that has been wet with the tastant on the subject's tongue. The subject is asked to identify the taste (e.g., sweet). Then, on a 5-point scale (0-4, ranging from none to very intense) they are asked to rate the intensity of the taste. The process is repeated for each of the three tastants. The consistency of the subject responses over the 4 sessions will be analyzed.
Ability to feel pressure and discomfort after injection of lidocaine into the cheek
Time frame: 1 visit of 30 minutes after other 4 visits, average ~1 month total
Inject lidocaine as would be done in a dental visit, assess numbness to pressure and discomfort using the Baker Wong FACES scale (0-10) scale of discomfort, ranging from none to intense pain. The effectiveness of lidocaine will be assessed, and then the results compared to Outcome 1.
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 15 Jul 2020.
- Results publication: PubMed 25447751Infante MA, Moore EM, Nguyen TT, Fourligas N, Mattson SN, Riley EP. Objective assessment of ADHD core symptoms in children with heavy prenatal alcohol exposure. Physiol Behav. 2015 Sep 1;148:45-50. doi: 10.1016/j.physbeh.2014.10.014. Epub 2014 Oct 23.
- Results publication: PubMed 18426576Levitt JO. Practical aspects in the management of hypokalemic periodic paralysis. J Transl Med. 2008 Apr 21;6:18. doi: 10.1186/1479-5876-6-18.
- Results publication: PubMed 11143733Nakai Y, Milgrom P, Mancl L, Coldwell SE, Domoto PK, Ramsay DS. Effectiveness of local anesthesia in pediatric dental practice. J Am Dent Assoc. 2000 Dec;131(12):1699-705. doi: 10.14219/jada.archive.2000.0115.
- Results publication: PubMed 24938135Segal MM. We cannot say whether attention deficit hyperactivity disorder exists, but we can find its molecular mechanisms. Pediatr Neurol. 2014 Jul;51(1):15-6. doi: 10.1016/j.pediatrneurol.2014.04.014. Epub 2014 Apr 18. No abstract available.
- Results publication: PubMed 18174562Segal MM, Rogers GF, Needleman HL, Chapman CA. Hypokalemic sensory overstimulation. J Child Neurol. 2007 Dec;22(12):1408-10. doi: 10.1177/0883073807307095.
- Results publication: PubMed 9212254Segal MM, Douglas AF. Late sodium channel openings underlying epileptiform activity are preferentially diminished by the anticonvulsant phenytoin. J Neurophysiol. 1997 Jun;77(6):3021-34. doi: 10.1152/jn.1997.77.6.3021.
- Results publication: PubMed 23134619Teicher MH, Polcari A, Fourligas N, Vitaliano G, Navalta CP. Hyperactivity persists in male and female adults with ADHD and remains a highly discriminative feature of the disorder: a case-control study. BMC Psychiatry. 2012 Nov 7;12:190. doi: 10.1186/1471-244X-12-190.
- Saul R (2014) "ADHD Does Not Exist". HarperCollinsLink provided by the sponsor.
- Rozanski RJ, Primosch RE, Courts FJ (1988). Clinical efficacy of 1 and 2% solutions of lidocaine. Pediatr Dent.10:287-90Link provided by the sponsor.
- Segal MM, Jurkat-Rott K, Levitt J, Lehmann-Horn F (2014) Hypokalemic periodic paralysis - an owner's manualLink provided by the sponsor.
- Segal MM (2015) Devices, Kits, and Methods for Determining Sensitivity to Anesthetics. US Patent Filing 62/210,747, Filed 09/14/2015Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. We plan to share with the FDA the validation of the taste approach to testing lidocaine effectiveness, as part of an IDE application.
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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.
Michael Segal, MD PhD principal investigator
PhenoSolve, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Lidocaine gel and Injected lidocaine in people with ADHD and Controls, run by PhenoSolve, LLC 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 2 inclusion and 109 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 15 Jul 2020. 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Taste sensation after lidocaine or placebo (time frame: 4 visits each of 30 minutes within weeks of one another, average ~1 month total). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03680885, which also lists 7 linked publications.
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 15 Jul 2020.