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| Name | Class |
|---|---|
| NeurAbilities (formerly CRCNJ) | OTHER |
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This work will assess the prevalence in hard-to-treat ADHD of the ineffectiveness of the anesthetic Lidocaine.
Using a non-invasive, pain-free, taste-based approach to assess lidocaine effectiveness, the study will assess the frequency of ineffectiveness in the target population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational study of prevalence in hard-to-treat ADHD | Other | Subjects will be tested with lidocaine gel. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine gel | Drug | Septodont 5% oral lidocaine gel (NDC 0362-0221-10), 75 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Observational Study: Number of Participants With Lidocaine Ineffectiveness by Taste Test in Hard-to-treat ADHD | Subjects will be asked to identify each taste and its intensity. | on day of testing, approximately 30 minutes for clinic visit |
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Inclusion Criteria: ADHD
Exclusion Criteria for both arms:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Segal, MD PhD | PhenoSolve, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NeurAbilitis | Voorhees Township | New Jersey | 08043 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25447751 | Background | 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. | |
| 18426576 | Background | Levitt 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. |
| Label | URL |
|---|---|
| Saul R (2014) "ADHD Does Not Exist". HarperCollins | View source |
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The investigators 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 and in the general population.
3 months
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| ID | Title | Description |
|---|---|---|
| FG000 | Hard-to-treat ADHD | Subjects will be tested with Septodont 5% oral lidocaine gel (NDC 0362-0221-10), 75 mg pre-measured by compounding pharmacy and dispensed into blister pack |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Subjects who completed the study
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| ID | Title | Description |
|---|---|---|
| BG000 | Hard-to-treat ADHD | Subjects will be tested with Septodont 5% oral lidocaine gel (NDC 0362-0221-10), 75 mg pre-measured by compounding pharmacy and dispensed into blister pack |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Observational Study: Number of Participants With Lidocaine Ineffectiveness by Taste Test in Hard-to-treat ADHD | Subjects will be asked to identify each taste and its intensity. | Study population vs. previously published studies in pediatric populations (Nakai et al, 2000) | Posted | Count of Participants | Participants | on day of testing, approximately 30 minutes for clinic visit |
|
|
on day of testing, approximately 60 minutes for clinic visit
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hard-to-treat ADHD | Subjects will be tested with Septodont 5% oral lidocaine gel (NDC 0362-0221-10), 75 mg pre-measured by compounding pharmacy and dispensed into blister pack |
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This was an observational study without controls, as there were no controls available at the site. NeurAbilities is a clinic dedicated to treating patients with neurological diagnoses. To do statistics, the study will need to be repeated at a site that can provide controls.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lynn Feldman | PhenoSolve | 617-879-1670 | lynn@phenosolve.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 19, 2019 | Jun 11, 2021 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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Using a taste-based test before and after the application of lidocaine gel to the tongue, we will assess the degree to which lidocaine is effective at blocking taste in those with hard-to-treat ADHD
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The scoring of the lidocaine test is masked, using the coded identity of the tastes. The tastes will be assessed in random order. The subjects and other study personnel will be told not to discuss what the subject could or couldn't taste. Scoring will not be shared with the testing site until all testing is complete.
This is one of the last studies with an IRB for each arm and site. Hence it appears to be a single arm, but the other arms are separately registered with ClinicalTrials.gov
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| 11143733 | Background | Nakai 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. |
| 24938135 | Background | Segal 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. |
| 18174562 | Background | Segal MM, Rogers GF, Needleman HL, Chapman CA. Hypokalemic sensory overstimulation. J Child Neurol. 2007 Dec;22(12):1408-10. doi: 10.1177/0883073807307095. |
| 9212254 | Background | Segal 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. |
| 23134619 | Background | Teicher 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.10:287-90 | View source |
| Segal MM, Jurkat-Rott K, Levitt J, Lehmann-Horn F (2014) Hypokalemic periodic paralysis - an owner's manual | View source |
| Segal MM (2015) Devices, Kits, and Methods for Determining Sensitivity to Anesthetics. US Patent Filing 62/210,747, Filed 09/14/2015 | View source |
| Companion study | View source |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Hard-to-treat ADHD (does not respond to available ADHD drugs) | Count of Participants | Participants |
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| Participants |
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|
| 0 |
| 28 |
| 0 |
| 28 |
| 0 |
| 28 |
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