Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02777931 | Efficacy and Safety of NFC-1 in Adolescents With Genetic Disorders Impacting mGluR and ADHD | PHASE2 | COMPLETED | 101 | — | — | Jun 1, 2016 | Feb 17, 2017 | Aug 11, 2021 | 1 | United States |
| NCT03006367 | Pharmacokinetic and Tolerability Study of NFC-1 in Subjects Aged 6-17 Years With ADHD | PHASE1 | COMPLETED | 32 | — | — | Jan 7, 2017 | Mar 6, 2017 | Jul 6, 2021 | 3 | United States |
The ADHD-RS-5 is comprised of 18 frequency items and 12 impairment items. Each frequency item was scored on a scale from 0 = "Never or rarely" to 3 = "Very often". The ADHD-RS-5 total score was calculated as the sum of the 18 frequency item scores. The total score ranges from 0 to 54. Higher scores indicate greater symptom severity. Change from baseline value were calculated as the assessment value minus the baseline value.
The CGI-I item is rated on a 7-point scale from 1 = "Very much improved", 2 = "Much improved", 3 = "Minimally improved", 4 = "No change", 5 = "Minimally worse", 6 = "Much worse", 7 = "Very much worse". Response is defined as achieving a CGI-I score of 1 or 2, scores of 3 to 7 or missing are defined as Non Response
| Arm | Type | Description |
|---|---|---|
| NFC-1 | EXPERIMENTAL | Doses of NFC-1 will be administered as 100, 200, or 400 mg twice daily as capsules for oral administration. |
| Placebo | PLACEBO_COMPARATOR | Matching placebo capsules. |
| NFC-1 100 mg | EXPERIMENTAL | Single Dose of NFC-1 100 mg |
| NFC-1 200 mg | EXPERIMENTAL | Single Dose of NFC-1 200 mg |
| NFC-1 400 mg | EXPERIMENTAL | Single Dose of NFC-1 400 mg |
| NFC-1 800 mg | EXPERIMENTAL | Single Dose of NFC-1 800 mg |
| Name | Type | Description |
|---|---|---|
| NFC-1 | DRUG | NFC-1 is supplied as size 2 hard gelatin capsules. |
| Placebo | DRUG | Matching placebo capsules |
| NFC-1 100 mg | DRUG | - |
| NFC-1 200 mg | DRUG | - |
| NFC-1 400 mg | DRUG | - |
| NFC-1 800 mg | DRUG | - |
Inclusion Criteria: * Subject has ADHD as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) and Version 5 of the Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-5) ≥ 28 at Baseline with or without conventional ADHD therapy. * Subject has an int...