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NRCT-101SR for ADHD (ADHD Trial)
Phase 2 & 3
Recruiting
Research Sponsored by Neurocentria, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has a primary diagnosis of ADHD according to the DSM-5 classification, confirmed with MINI using DSM-5 probes
Male or female, 13-17 years of age at screening
Must not have
History of poor kidney function; corrected estimated glomerular filtration rate (eGFR) < 90 mL/min/m2
Female subjects who are pregnant and/or lactating and/or sexually active women of childbearing potential (WOCBP) not agreeing to use birth control methods outlined in inclusion criterion
Timeline
Screening 3 weeks
Treatment Varies
Follow Up over 6 weeks
Summary
This trial aims to determine if NRCT-101SR is effective and safe in treating teenagers with ADHD.
Who is the study for?
This trial is for young people aged 13-17 who have been diagnosed with ADHD. The specific eligibility criteria to join the study are not provided, but typically participants must meet certain health standards and cannot be taking conflicting medications.
What is being tested?
The trial is testing NRCT-101SR, a medication intended to treat ADHD in adolescents. Participants will either receive NRCT-101SR or a placebo (a substance with no therapeutic effect) to compare effectiveness and safety.
What are the potential side effects?
While the exact side effects of NRCT-101SR are not listed, common side effects for ADHD medications can include sleep problems, decreased appetite, mood swings, and increased blood pressure or heart rate.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with ADHD according to DSM-5.
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I am between 13 and 17 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My kidney function is below normal levels.
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I am not pregnant, breastfeeding, or if capable of becoming pregnant, I agree to use birth control as required.
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My liver tests are higher than normal.
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I have never been hospitalized for severe depression, bipolar, schizophrenia, or similar conditions.
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I have a history of serious gut issues like chronic diarrhea or Crohn's disease.
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I have a history of hepatitis B or C.
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I have a severe physical disability that does not affect my thinking but limits my ability to complete tests.
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My family has a history of sudden heart-related deaths or irregular heartbeats.
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I have a history of serious heart problems.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ over 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~over 6 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Objective performance/Permanent Product Measure of Performance (PERMP-C) Math Tests
Secondary study objectives
Core Symptoms/ADHD Rating Scale (ADHD-RS-5)
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental ArmExperimental Treatment1 Intervention
Up to 2,000 mg/day
Group II: Control ArmPlacebo Group1 Intervention
Matching placebo
Find a Location
Who is running the clinical trial?
Neurocentria, Inc.Lead Sponsor
6 Previous Clinical Trials
382 Total Patients Enrolled
3 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
303 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Guy Bar-Klein, PhDStudy DirectorNuerocentria