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Electrolyte Supplement
Single-dose Potassium Supplementation in Patients With ADHD for Whom the Anesthetic Lidocaine is Ineffective
Phase 1 & 2
Waitlist Available
Led By Michael M Segal, MD PhD
Research Sponsored by AlkaliDx, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and ~1-2 hours later, 1 hour after intervention
Awards & highlights
All Individual Drugs Already Approved
Summary
This trial is testing if a single dose of potassium can help reduce symptoms in people with ADHD who haven't been treated or whose current treatments aren't working well. Potassium is a mineral that helps with nerve function and muscle control. The study will measure changes in ADHD symptoms after taking potassium.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and ~1 hour after intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and ~1 hour after intervention
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Prevalence of lidocaine ineffectiveness in those with ADHD
Secondary study objectives
Change in ADHD-RS questionnaires
Change in Clinical Global Impression Physician Completed Questionnaire
Change in scores using Quotient ADHD System
+2 moreAwards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
4Treatment groups
Active Control
Placebo Group
Group I: Lidocaine-ineffective ADHD: InterventionActive Control1 Intervention
Single-dose potassium gluconate oral capsule intervention for ADHD subjects for whom lidocaine is ineffective
Group II: Lidocaine-effective ADHD: InterventionActive Control1 Intervention
Single-dose potassium gluconate oral capsule intervention for ADHD subjects for whom lidocaine is effective
Group III: Lidocaine-effective ADHD: PlaceboPlacebo Group1 Intervention
Single-dose placebo oral capsule intervention for ADHD subjects for whom lidocaine is effective
Group IV: Lidocaine-ineffective ADHD: placeboPlacebo Group1 Intervention
Single-dose placebo oral capsule intervention for ADHD subjects for whom lidocaine is ineffective
Find a Location
Who is running the clinical trial?
AlkaliDx, Inc.Lead Sponsor
Michael M Segal, MD PhDPrincipal InvestigatorPhenoSolve, LLC
2 Previous Clinical Trials
45 Total Patients Enrolled
Mark Mintz, MDPrincipal InvestigatorCNNH & CRCNJ