Early Phase 1 N=28 Health Services Research

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

ADHD

Bottom Line

View on ClinicalTrials.gov: NCT04167189 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2021

Primary outcome: Primary: Observational Study: Number of Participants With Lidocaine Ineffectiveness by Taste Test in Hard-to-treat ADHD — 1; 27 Participants

Study Design & Population

Study type: Interventional
Phase: Early Phase 1
Interventions: Lidocaine gel (Drug)
Age: Pediatric, Adult · 7+ yrs
Sex: All
Sponsor: PhenoSolve, LLC
Primary completion: Mar 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Observational Study: Number of Participants With Lidocaine Ineffectiveness by Taste Test in Hard-to-treat ADHD	1; 27	—

Summary

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

Eligibility Criteria

Inclusion Criteria: ADHD

Exclusion Criteria for both arms:

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;
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);
mouth sores;
Ehlers Danlos syndrome, and
red hair.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04167189). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.