NCT03563573

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

Single-dose Potassium Supplementation in ADHD Patients With Lidocaine Ineffectiveness

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: AlkaliDx, Inc. · Industry
• Sex: All
• Age: 13 Years – 49 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Subjects with a confirmed diagnosis of Attention Deficit Hyperactivity Disorder (ADHD), who are either untreated or poorly controlled with existing ADHD therapy, will be recruited for a single, four-hour session. Each subject will be tested for lidocaine effectiveness using the application of lidocaine gel to the tongue and assessment by taste. The subjects will then be assigned to two arms, (1) lidocaine sensitive (effective) or (2) lidocaine insensitive (ineffective), and then randomized as to an intervention of potassium supplementation or a placebo. Each subject will: * Complete questionnaires about their history of certain symptoms and a food diary. * Get an ECG to exclude those with arrhythmias. * Have their baseline serum potassium tested * Have measures of ADHD symptoms performed. Then each subject will receive the intervention of a single dose of the potassium or placebo. After the wait of one hour, a repeat serum potassium and measurement of symptoms will be performed. Note; The FDA also requires a Columbia Suicide Severity Rating Scale (C-SSRS) for all ADHD trials

Conditions

• ADHD

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-07-01
• Primary completion: 2018-11-04
• Completion: 2018-12-31
• First posted: 2018-06-20
• Last updated: 2018-06-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study