ADHDPhase 1/2NCT03563573
Single-dose Potassium Supplementation in Patients With ADHD for Whom the Anesthetic Lidocaine is Ineffective
A Phase 1/2 study testing Potassium Gluconate Oral Capsule in people with ADHD, run by AlkaliDx, Inc. at 1 site in United States.
Trial summary
Randomized, controlled, double-blind trial of the effect of a single dose of potassium on ADHD symptoms as measured by changes in measures of symptoms of ADHD correlated with the results of their Lidocaine Effectiveness Test. Read more about this study
- Who is it for?
- Ages 13 to 49 years
- Conditions the study is for
- ADHD
- What is being tested?
- Potassium Gluconate Oral Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2018to 31 Dec 2018
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 49 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Previously documented ADHD diagnosis
- Untreated or taking existing ADHD drugs, but symptoms poorly controlled (e.g., symptoms not well managed by amphetamines, including ongoing inattention and impulsivity)
Who cannot join
- Well treated with existing ADHD medication
- Epilepsy
- IQ less than 80
- Severe head trauma that led to loss of consciousness for more than an hour or required surgery
- Birth weight below 5 pounds or 2270 grams
- Severe autism (milder conditions described as Asperger syndrome or "high-functioning autism" are not excluded)
Show all 55Show fewer
- Comorbid psychiatric disorders, such as generalized anxiety disorder, major depressive disorder, schizophrenia and schizoaffective disorder, bipolar disorder, and any co-morbid condition at the discretion of the PI that would interfere with a patient's ability to participate
- Mouth lesions, known to temporarily interfere with lidocaine effectiveness
- Renal disease or abnormal kidney function or receiving dialysis
- An individual has a factor likely to reduce penetrance, including excessive salt loss, such as caked salt on the body after exercise and Cystic fibrosis in a relative suggestive of the individual being a carrier.
- Heart arrhythmia, known or evident on ECG
- Known intolerance or allergy to lidocaine
- Already taking supplemental potassium or renin angiotensin aldosterone inhibitors or other potassium elevating agents (see list below)
- 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.
United States1 site
Clinical Research Center of New Jersey (CRCNJ)
Voorhees Township, New Jersey, 08043
About this study
Official title: Single-dose Potassium Supplementation in ADHD Patients With Lidocaine Ineffectiveness
Randomized, controlled, double-blind trial of the effect of a single dose of potassium on ADHD symptoms as measured by changes in measures of symptoms of ADHD correlated with the results of their Lidocaine Effectiveness Test.
Read the detailed description
Subjects with a confirmed diagnosis of Attention Deficit Hyperactivity Disorder (ADHD), who are either untreated or poorly controlled with existing ADHD therapy, will be recruited for a single, four-hour session.
Each subject will be tested for lidocaine effectiveness using the application of lidocaine gel to the tongue and assessment by taste.
The subjects will then be assigned to two arms, (1) lidocaine sensitive (effective) or (2) lidocaine insensitive (ineffective), and then randomized as to an intervention of potassium supplementation or a placebo.
Each subject will:
- Complete questionnaires about their history of certain symptoms and a food diary.
- Get an ECG to exclude those with arrhythmias.
- Have their baseline serum potassium tested
- Have measures of ADHD symptoms performed.
Then each subject will receive the intervention of a single dose of the potassium or placebo.
After the wait of one hour, a repeat serum potassium and measurement of symptoms will be performed.
Note; The FDA also requires a Columbia Suicide Severity Rating Scale (C-SSRS) for all ADHD trials
- Conditions
- ADHD
- Being tested
- Potassium Gluconate Oral Capsule, Placebo oral capsule
- Keywords
- Conditions in which lidocaine is ineffective
- 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.
Potassium Gluconate Oral CapsuleDrug
Each subject will receive a dose of ~8 mg/kg of potassium. We will be giving a maximum of 14 mEq in a single dose.
Placebo oral capsuleDrug
Each subject will receive a dose of ~8 mg/kg of a placebo capsule
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine-effective ADHD: Intervention | Active comparator | Single-dose potassium gluconate oral capsule intervention for ADHD subjects for whom lidocaine is effective Receives: Drug: Potassium Gluconate Oral Capsule |
| Lidocaine-effective ADHD: Placebo | Placebo comparator | Single-dose placebo oral capsule intervention for ADHD subjects for whom lidocaine is effective Receives: Drug: Placebo oral capsule |
| Lidocaine-ineffective ADHD: Intervention | Active comparator | Single-dose potassium gluconate oral capsule intervention for ADHD subjects for whom lidocaine is ineffective Receives: Drug: Potassium Gluconate Oral Capsule |
| Lidocaine-ineffective ADHD: placebo | Placebo comparator | Single-dose placebo oral capsule intervention for ADHD subjects for whom lidocaine is ineffective Receives: Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of lidocaine ineffectiveness in those with ADHD
Investigator assesses identification and intensity of tastes (such as sweet) before and after application of oral lidocaine gel to the tongue.
Measured: Baseline
Secondary outcomes (5)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Investigator documentation of adverse reactions to either lidocaine or potassium
Measured: 1-2 hours after intervention
Other discomforts
Investigator documentation of complaints or minor discomforts
Measured: 1-2 hours after intervention
Change in ADHD-RS questionnaires
The questionnaire is a standard assessment tool for measuring the level of ADHD symptoms. The ADHD-RS-IV is for adults and the ADHD-RSM-5 is for teenagers. This test has been validated for measuring the impact of drugs in ADHD, typically multi-dose, multi-week changes.
Since this study is a single-dose, several-hour study, the Investigators will complete only the portions designed to done with the patient and by the clinician; sections designed to be completed by parents and teachers. The results will establish expectations for future multi-dose studies.
All scores on a range of None, Mild, Moderate, Severe.
- Carelessness
- Difficulty sustaining attention in activities
- No follow through
- Can't organize
- Avoids/dislikes tasks requiring sustained mental effort
- Loses Important items
- Easily distractible
- Forgetful in daily activities
Measured: Baseline and ~1-2 hours later, 1 hour after intervention
Change in Clinical Global Impression Physician Completed Questionnaire
Clinician-assessed improvement in overall symptoms, using CGI S (severity) as baseline and CGI I (improvement) to track any change.
Investigator assesses "Compared to his or her condition at baseline, how much has he or she changed?"
Very much improved Much improved Minimally improved No change Minimally worse Much worse Very much worse
Measured: Baseline and ~1-2 hours later, 1 hour after intervention
Change in scores using Quotient ADHD System
The Quotient device (http://www.quotient-adhd.com) tracks scores on 6 factors of motion analysis; 6 factors of attention response; and 8 factors of attention state. The subject plays a diagnostic "video game" and the machine tracks movement of the head, and speed and accuracy of the mouse clicks.
The first assessment will serve as a baseline and the assessment post-intervention will measure any changes. (all scores from 0-100)
Motion Analysis (including Immobility Duration, Number of movements, displacement, area, spacial complexity, temporal scaling)
Attention Response Analysis (including adjusted Accuracy, Omission Errors, Commission Errors, Latency, Variability, Coefficient of Variation for response latency)
Attention State Analysis (including number of shifts, Attentive, Impulsive, Distracted, Disengaged, Random, Minimal, Contrary, Overall Results)
Measured: Baseline and ~1 hour after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2018
- Study start1 Jul 2018 (estimated)
- Primary completion4 Nov 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
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
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The trial will have 2 arms, lidocaine sensitive (effective) and lidocaine insensitive (ineffective). The sample will be enriched to have 50% in each arm. Within each arm, subjects will be randomized on a 1-to-1 allocation to the treatment or control groups. The investigators will adopt an iterative approach of testing of batches of subjects because (1) the frequency of lidocaine-insensitivity is only known approximately, (2) the frequency may be unevenly distributed across ethnic groups, and (3) the exact effect size of the potassium is not known, though reported to be high in off-label use in clinical settings with more chronic administration. At the end of testing 40 patients, the results will be analyzed for statistical significance. (1) If the results are statistically significant with a 95% confidence, the testing may stop with the first batch of 40 subjects. (2) If not, sequential, iterative batches of 20 subjects will be tested, and the results reanalyzed.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AlkaliDx, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael M Segal, MD PhD, Principal investigator, PhenoSolve, LLCMark Mintz, MD, Principal investigator, CNNH & CRCNJ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03563573
- Sponsor's protocol ID
- 2017-01A
- Status last verified
- Jun 2018
- First submitted
- 15 May 2018
- Last updated
- 20 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to submit for publication descriptions of what was accomplished, and the evaluations as described in the study, including the incidence of lidocaine ineffectiveness in those with ADHD.
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 20 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-dose Potassium Supplementation in ADHD Patients With Lidocaine Ineffectiveness
- ClinicalTrials.gov ID
- NCT03563573
- Acronym / sponsor ID
- 2017-01A
- Conditions
- ADHD
- Keywords
- Conditions in which lidocaine is ineffective
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- AlkaliDx, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2018 (estimated)
- Primary completion
- 4 Nov 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 20 Jun 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.
Randomized, controlled, double-blind trial of the effect of a single dose of potassium on ADHD symptoms as measured by changes in measures of symptoms of ADHD correlated with the results of their Lidocaine Effectiveness Test.
Detailed description
Subjects with a confirmed diagnosis of Attention Deficit Hyperactivity Disorder (ADHD), who are either untreated or poorly controlled with existing ADHD therapy, will be recruited for a single, four-hour session.
Each subject will be tested for lidocaine effectiveness using the application of lidocaine gel to the tongue and assessment by taste.
The subjects will then be assigned to two arms, (1) lidocaine sensitive (effective) or (2) lidocaine insensitive (ineffective), and then randomized as to an intervention of potassium supplementation or a placebo.
Each subject will:
- Complete questionnaires about their history of certain symptoms and a food diary.
- Get an ECG to exclude those with arrhythmias.
- Have their baseline serum potassium tested
- Have measures of ADHD symptoms performed.
Then each subject will receive the intervention of a single dose of the potassium or placebo.
After the wait of one hour, a repeat serum potassium and measurement of symptoms will be performed.
Note; The FDA also requires a Columbia Suicide Severity Rating Scale (C-SSRS) for all ADHD trials
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- The trial will have 2 arms, lidocaine sensitive (effective) and lidocaine insensitive (ineffective). The sample will be enriched to have 50% in each arm. Within each arm, subjects will be randomized on a 1-to-1 allocation to the treatment or control groups. The investigators will adopt an iterative approach of testing of batches of subjects because (1) the frequency of lidocaine-insensitivity is only known approximately, (2) the frequency may be unevenly distributed across ethnic groups, and (3) the exact effect size of the potassium is not known, though reported to be high in off-label use in clinical settings with more chronic administration. At the end of testing 40 patients, the results will be analyzed for statistical significance. (1) If the results are statistically significant with a 95% confidence, the testing may stop with the first batch of 40 subjects. (2) If not, sequential, iterative batches of 20 subjects will be tested, and the results reanalyzed.
| Arm | Type | Receives |
|---|---|---|
| Lidocaine-effective ADHD: Intervention | Active comparator | Drug: Potassium Gluconate Oral CapsuleSingle-dose potassium gluconate oral capsule intervention for ADHD subjects for whom lidocaine is effective |
| Lidocaine-effective ADHD: Placebo | Placebo comparator | Drug: Placebo oral capsuleSingle-dose placebo oral capsule intervention for ADHD subjects for whom lidocaine is effective |
| Lidocaine-ineffective ADHD: Intervention | Active comparator | Drug: Potassium Gluconate Oral CapsuleSingle-dose potassium gluconate oral capsule intervention for ADHD subjects for whom lidocaine is ineffective |
| Lidocaine-ineffective ADHD: placebo | Placebo comparator | Drug: Placebo oral capsuleSingle-dose placebo oral capsule intervention for ADHD subjects for whom lidocaine is ineffective |
Who may qualify
- Ages
- 13 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Previously documented ADHD diagnosis
- Untreated or taking existing ADHD drugs, but symptoms poorly controlled (e.g., symptoms not well managed by amphetamines, including ongoing inattention and impulsivity)
Key exclusion criteria (55 listed)
- Well treated with existing ADHD medication
- Epilepsy
- IQ less than 80
- Severe head trauma that led to loss of consciousness for more than an hour or required surgery
- Birth weight below 5 pounds or 2270 grams
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 |
|---|---|---|
| Potassium Gluconate Oral CapsuleEach subject will receive a dose of ~8 mg/kg of potassium. We will be giving a maximum of 14 mEq in a single dose. | Drug | Lidocaine-effective ADHD: Intervention, Lidocaine-ineffective ADHD: Intervention |
| Placebo oral capsuleEach subject will receive a dose of ~8 mg/kg of a placebo capsule | Drug | Lidocaine-effective ADHD: Placebo, Lidocaine-ineffective ADHD: placebo |
Primary outcome
Prevalence of lidocaine ineffectiveness in those with ADHD
Time frame: Baseline
Investigator assesses identification and intensity of tastes (such as sweet) before and after application of oral lidocaine gel to the tongue.
5 secondary outcomes
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 1-2 hours after intervention
Other discomforts
Time frame: 1-2 hours after intervention
Change in ADHD-RS questionnaires
Time frame: Baseline and ~1-2 hours later, 1 hour after intervention
Change in Clinical Global Impression Physician Completed Questionnaire
Time frame: Baseline and ~1-2 hours later, 1 hour after intervention
Change in scores using Quotient ADHD System
Time frame: Baseline and ~1 hour after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2018.
- Background: 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.
- Background: 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.
- Background: 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.
- Background: 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.
- Background: 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.
- Background: 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.
- Background: 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.
- 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.
- Saul R (2014) "ADHD Does Not Exist". HarperCollins.Link 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 submit for publication descriptions of what was accomplished, and the evaluations as described in the study, including the incidence of lidocaine ineffectiveness in those with ADHD.
Related trials for ADHD
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD
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 M Segal, MD PhD principal investigator
PhenoSolve, LLC
Mark Mintz, MD principal investigator
CNNH & CRCNJ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Potassium Gluconate Oral Capsule in people with ADHD, run by AlkaliDx, Inc. 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 55 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: status not confirmed, as of the sponsor's last update on 20 Jun 2018. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Prevalence of lidocaine ineffectiveness in those with ADHD (time frame: Baseline). 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 NCT03563573, 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 20 Jun 2018.