ADHD
Conditions
Brief summary
A combination therapy of NRCT-101 with NRCT-202 is being developed for patients with ADHD.
Detailed description
A multi-center, randomized, double-blind, parallel, adaptive-design clinical trial to evaluate the safety and efficacy of co-administration of NRCT-101SR and low dose NRCT- 202XR compared to low or high dose of NRCT-202XR and placebo NRCT-101SR over a 6-week period in approximately 60 pediatric subjects (13-17 years of age) with ADHD. Subjects' enrollment will be conducted in two stages. In stage 1, subjects are planned to be randomized to one of the following two arms (1:1 ratio): Arm 1: NRCT-101SR and low dose NRCT-202XR Arm 2: NRCT-101SR placebo and high dose NRCT-202XR In stage 2, a third study arm will be added (Arm 3 - NRCT-101SR placebo and low dose NRCT-202XR. The study population will include male and female subjects (sex assigned at birth) of all races/ethnicities with ADHD.
Interventions
DRUGNRCT-101SR, NRCT-202XR
NRCT-101SR in combination with NRCT-202XR or NRCT-202XR alone
Sponsors
Neurocentria, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
A multi-center, randomized, double-blind, parallel, adaptive-design clinical trial
Eligibility
Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CGI-S | 6 weeks |
| SDSE-RS | 6 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CBRS-P | 6 weeks | and academic problems in children between the ages of 6 and 18 years and are reported by parents. |
| DPREMB-R | 6 weeks | — |
| ADHD-RS-5 | 6 weeks | — |
Countries
United States
Outcome results
None listed