Observational Study to Assess the Frequency of Lidocaine Ineffectiveness in Hard-to-treat ADHD

NCT04167189 | Completed Early Phase 1 Results FDA Drug

• 1 other identifier: 2019-01A
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

This work will assess the prevalence in hard-to-treat ADHD of the ineffectiveness of the anesthetic Lidocaine.

Conditions

ADHD

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Observational study of prevalence in hard-to-treat ADHD

OTHER

Subjects will be tested with lidocaine gel.

Drug: Lidocaine gel

Interventions

Lidocaine gel DRUG

Septodont 5% oral lidocaine gel (NDC 0362-0221-10), 75 mg

Also known as: Intervention

Observational study of prevalence in hard-to-treat ADHD

Eligibility Criteria

• Age: 7 Years - 49 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may not qualify if:

• known adverse reactions to lidocaine
• epilepsy, IQ \<80, severe head trauma, birth weight \<2270 grams, and severe autism;
• treatment currently with potassium or potassium-elevating drugs such as renin-angiotensin-aldosterone blockers;
• mouth sores;
• Ehlers Danlos syndrome, and
• red hair.

Sponsors & Collaborators

• PhenoSolve, LLC: lead
• NeurAbilities (formerly CRCNJ): collaborator

Study Sites (1)

NeurAbilitis

Voorhees Township, New Jersey, 08043, 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

Limitations and Caveats

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.

Results Point of Contact

• Title: Lynn Feldman
• Organization: PhenoSolve

lynn@phenosolve.com

617-879-1670

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. 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
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: November 12, 2019
• First Posted: November 18, 2019
• Study Start: January 20, 2018
• Primary Completion: March 30, 2020
• Study Completion: March 30, 2020
• Last Updated: July 2, 2021
• Results First Posted: July 2, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 3 months

Locations

US (1)