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| Name | Class |
|---|---|
| Jacobi Medical Center | OTHER |
| Boston Clinical Trials | OTHER |
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This work will assess the prevalence in the general population of the ineffectiveness of the anesthetic Lidocaine compared to males with ADHD and females with ADHD with or without PMS.
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. We will use an identical protocol at two sites: Jacobi hospital and Boston Clinical Trials.
The controlled trial will assess the ability of lidocaine oral gel to block taste (e.g., sweet) in 100 teens and adults, half with a history of ADHD, and for females, we will compare the sub-groups with and without premenstrual syndrome (PMS).
This study will also be compared with a similar assessment among a specialized ADHD population (NCT03563573), that does not respond to existing medication..
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All subjects | Experimental | All subjects get the lidocaine taste test |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine gel | Drug | Lidocaine gel (0.75 g premeasured dose of Septodont 5% oral gel NDC 0362-0221-10) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Lidocaine Ineffectiveness | Subjects will be asked to identify each taste and its intensity on a 0 (no taste) to 10 (very intense) scale before and after application of Lidocaine. Lidocaine effectiveness was quantitated as the reduction or elimination of taste by lidocaine compared to taste scores reported before lidocaine. For each of the four before/after pairs, the change in taste intensity was calculated, a weighted average score was computed. Incorrectly identified tastes were excluded. Scores of a reduction in taste ≥50% were considered to be lidocaine effective. | 30 minute visit, added on to a regular clinic visit |
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Inclusion Criteria:
Exclusion Criteria for both arms:
(1) known adverse reactions to lidocaine; (2) ADHD, ADD, and other inattention disorders; (3) epilepsy, IQ <80, severe head trauma, birth weight <2270 grams, and severe autism; (4) treatment currently with potassium or potassium-elevating drugs such as renin-angiotensin-aldosterone blockers; (5) 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); (6) mouth sores; (7) Ehlers Danlos syndrome, (8) red hair, and (9) current pregnancy.
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| Name | Affiliation | Role |
|---|---|---|
| Michael Segal, MD PhD | PhenoSolve, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Clinical Trials | Boston | Massachusetts | 02131 | United States | ||
| Jacobi Medical Center |
| 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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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 and in the general population.
9-12 months
Researchers
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| ID | Title | Description |
|---|---|---|
| FG000 | Males Without ADHD | Arm 1 Lidocaine gel: Lidocaine gel 5% |
| FG001 | Males With ADHD | Arm 2 Lidocaine gel: Lidocaine gel 5% |
| FG002 | Females Without ADHD and Without PMS | Arm 3 Lidocaine gel: Lidocaine gel 5% |
| FG003 | Females Without ADHD, But With PMS | Arm 4 Lidocaine gel: Lidocaine gel 5% |
| FG004 | Females With ADHD and Without PMS | Arm 5 Lidocaine gel: Lidocaine gel 5% |
| FG005 | Females With ADHD and With PMS | Arm 6 Lidocaine gel: Lidocaine gel 5% |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Males Without ADHD | ADHD-RS <18 |
| BG001 | Males With ADHD | ADHD-RS ≥18 |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Number of Subjects With Lidocaine Ineffectiveness | Subjects will be asked to identify each taste and its intensity on a 0 (no taste) to 10 (very intense) scale before and after application of Lidocaine. Lidocaine effectiveness was quantitated as the reduction or elimination of taste by lidocaine compared to taste scores reported before lidocaine. For each of the four before/after pairs, the change in taste intensity was calculated, a weighted average score was computed. Incorrectly identified tastes were excluded. Scores of a reduction in taste ≥50% were considered to be lidocaine effective. | Posted | Count of Participants | Participants | 30 minute visit, added on to a regular clinic visit |
|
1 day
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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 | All Subjects | All subjects were monitored as a single group for adverse reactions |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lynn Feldman | AlkaliDx | 16178791670 | lynn@alkalidx.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 19, 2019 | Jun 11, 2021 | Prot_SAP_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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A group of 100 subjects will be assessed.
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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.
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| The Bronx |
| New York |
| 10461 |
| United States |
| 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 |
| Females Without ADHD and Without PMS |
ADHD-RS <18 and Custom PMS <12 |
| BG003 | Females Without ADHD, But With PMS | ADHD-RS <18 and Custom PMS ≥12 |
| BG004 | Females With ADHD and Without PMS | ADHD-RS ≥18 and Custom PMS <12 |
| BG005 | Females With ADHD and With PMS | ADHD-RS ≥18 and Custom PMS ≥12 |
| BG006 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
ADHD-RS ≥18 |
| OG002 | Females Without ADHD and Without PMS | ADHD-RS <18 and Custom PMS <12 |
| OG003 | Females Without ADHD, But With PMS | ADHD-RS <18 and Custom PMS ≥12 |
| OG004 | Females With ADHD and Without PMS | ADHD-RS ≥18 and Custom PMS <12 |
| OG005 | Females With ADHD and With PMS | ADHD-RS ≥18 and Custom PMS ≥12 |
|
|
|
| 0 |
| 90 |
| 0 |
| 90 |
| 0 |
| 90 |
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