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Single-dose Potassium Supplementation in Patients With ADHD for Whom the Anesthetic Lidocaine is Ineffective

NCT03563573 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2018-06-20

No results posted yet for this study

Summary

Randomized, controlled, double-blind trial of the effect of a single dose of potassium on ADHD symptoms as measured by changes in measures of symptoms of ADHD correlated with the results of their Lidocaine Effectiveness Test.

Conditions

  • ADHD

Interventions

DRUG

Potassium Gluconate Oral Capsule

Each subject will receive a dose of \~8 mg/kg of potassium. We will be giving a maximum of 14 mEq in a single dose.

DRUG

Placebo oral capsule

Each subject will receive a dose of \~8 mg/kg of a placebo capsule

Sponsors & Collaborators

  • AlkaliDx, Inc.

    lead INDUSTRY

Principal Investigators

  • Michael M Segal, MD PhD · PhenoSolve, LLC

  • Mark Mintz, MD · CNNH & CRCNJ

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-01
Primary Completion
2018-11-04
Completion
2018-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03563573 on ClinicalTrials.gov