NRCT-101-SR for ADHD

Recruiting in Palo Alto (17 mi)

+8 other locations

Overseen ByAnn Childress, M.D.

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: Neurocentria, Inc.

Prior Safety Data

Approved in 1 jurisdiction

Trial Summary

What is the purpose of this trial?This trial tests a new medication called NRCT-101SR to see if it helps adults with ADHD. Participants will take the medication regularly, and researchers will measure its effectiveness by looking at math test scores and symptom ratings before and after treatment.

Eligibility Criteria

Adults over 18 with ADHD diagnosed by DSM-5 criteria, who have not taken ADHD medication recently. They must be fluent in English, have completed at least 10 years of education, and weigh between 50 kg and 105 kg. Participants should be able to see and hear well enough for cognitive tests.

Inclusion Criteria

I am 18 years old or older.

I have been diagnosed with ADHD according to DSM-5.

I am fluent in English and can read, write, and communicate effectively.

My weight is between 50 and 105 kg, and my lean body mass is 75 kg or less.

Exclusion Criteria

My kidney function is poor, with an eGFR below 40 mL/min/m2.

I have a history of serious gut issues like chronic diarrhea or Crohn's disease.

I am not pregnant or breastfeeding.

I do not have a severe physical disability that affects my ability to complete tests.

I have a history of serious heart problems.

My family has a history of sudden heart-related deaths or irregular heartbeats.

I drink more than the specified weekly alcohol limit.

Participant Groups

The trial is testing NRCT-101SR's effectiveness and safety against a placebo in adults with ADHD. Patients will either receive the actual drug or a placebo to compare results.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: NRCT-101SRExperimental Treatment1 Intervention

Two-tiered fixed dose of 1,500 or 2,000 mg/day. Two NRCT-101SR tablets (375 mg or 500 mg based on lean body mass) by mouth twice daily

Group II: Matching PlaceboPlacebo Group1 Intervention

NRCT-101SR is already approved in United States for the following indications:

🇺🇸 Approved in United States as NRCT-101SR for: