A Phase 2 Randomized Double-Blind, Parallel, Adaptive-Design, Clinical Trial to Evaluate the Safety and Efficacy of NRCT-101SR with NRCT-202XR Compared to NRCT-202XR Alone in Subjects with Attention-Deficit/Hyperactivity Disorder

Launched by NEUROCENTRIA, INC. · Nov 1, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new combination treatment for Attention-Deficit/Hyperactivity Disorder (ADHD) using two medications called NRCT-101SR and NRCT-202XR. Researchers want to find out if this combination is safe and effective compared to using NRCT-202XR alone. The trial is currently recruiting participants, and it is open to both boys and girls aged 13 to 17 who have been diagnosed with ADHD and are already taking ADHD medication regularly.

To participate, individuals will need to meet certain criteria, such as having a confirmed ADHD diagnosis and experiencing side effects from their current medication. Participants can expect to undergo assessments and possibly receive the new treatment or continue with their current medication. This trial aims to improve ADHD treatment options, and both the young participants and their parents or guardians will need to give their consent to join. If you or a family member are interested and meet the eligibility requirements, this could be an opportunity to help advance ADHD research.

Gender

ALL

Eligibility criteria

• • 1. Male or female, 13-17 years of age at screening.
• • 2. Has a prior primary diagnosis of ADHD according to the DSM-5 classification evident by a medical record and confirmed with MINI using DSM-5 probes.
• • 3. Is taking ADHD medication 4-7 days/week, for at least 4 weeks at Screening and at least 6 weeks at Baseline.
• • 4. Has side effects identified using SDSE-RS at Screening and Baseline.
• • 5. CGI-S ≥ X (blinded) at Screening and Baseline.
• • 6. Must be fluent in English and communicate effectively with others.
• • 7. Both subject and parent/guardian willing and able to give informed assent/consent.
• • 8. Parent/guardian willing to serve as informant.