Prevalence of Lidocaine Ineffectiveness in Adults With and Without ADHD

NCT03676725 | Completed Early Phase 1 Results FDA Drug

• 1 other identifier: 2018-272
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

ADHD; PMS

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

All subjects

EXPERIMENTAL

All subjects get the lidocaine taste test

Drug: Lidocaine gel

Interventions

Lidocaine gel DRUG

Lidocaine gel (0.75 g premeasured dose of Septodont 5% oral gel NDC 0362-0221-10)

Also known as: Intervention

All subjects

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• PhenoSolve, LLC: lead
• Jacobi Medical Center: collaborator
• Boston Clinical Trials: collaborator

Study Sites (2)

Boston Clinical Trials

Boston, Massachusetts, 02131, United States

Location

Jacobi Medical Center

The Bronx, New York, 10461, United States

Location

Related Publications (7)

• 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.

  PMID: 25447751 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.

  PMID: 18426576 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.

  PMID: 11143733 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.

  PMID: 24938135 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.

  PMID: 18174562 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.

  PMID: 9212254 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.

  PMID: 23134619 BACKGROUND

Related Links

• Saul R (2014) "ADHD Does Not Exist". HarperCollins
• Rozanski RJ, Primosch RE, Courts FJ (1988). Clinical efficacy of 1 and 2% solutions of lidocaine. Pediatr Dent.10:287-90
• Segal MM, Jurkat-Rott K, Levitt J, Lehmann-Horn F (2014) Hypokalemic periodic paralysis - an owner's manual
• Segal MM (2015) Devices, Kits, and Methods for Determining Sensitivity to Anesthetics. US Patent Filing 62/210,747, Filed 09/14/2015
• Companion study

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methods

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Results Point of Contact

• Title: Lynn Feldman
• Organization: AlkaliDx

lynn@alkalidx.com

16178791670

Study Officials

• Michael Segal, MD PhD

  PhenoSolve, LLC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A group of 100 subjects will be assessed.

Study Record Dates

• First Submitted: September 17, 2018
• First Posted: September 19, 2018
• Study Start: August 14, 2019
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: October 6, 2022
• Results First Posted: July 14, 2021

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 9-12 months
• Access Criteria: Researchers

Locations

US (2)