At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 101 enrolled
Drug / intervention
NFC-1 +1 moredrug
Likely dose
Not stated in record
Key inclusion· 5
- ✓Confirmed ADHD diagnosis by DSM-5 with ADHD-RS-5 score ≥ 28 at baseline
- ✓Intelligence quotient (IQ) > 79 on WASI-II
- ✓Genotyped with confirmed disruptive mutations in GRM-network genes (GRM biomarker-positive)
- ✓General good health aside from ADHD, based on medical history, physical exam, vital signs, labs, and C-SSRS
Key exclusion· 4
- ✕Prior diagnosis of comorbid major psychiatric disorders including major depression, bipolar disease, schizophrenia, pervasive developmental disorder, or intellectual disability
- ✕Currently taking prohibited medication or unwilling to discontinue ADHD medication for the study
- ✕History of syncope, cardiac conduction problems, exercise-related cardiac events, or clinically significant bradycardia
- ✕History of stroke, chronic seizures, or major neurological disorder that would interfere with study participation or evaluation
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, 6-week, Double-blind, Randomized, Placebo-controlled, Parallel-design Study to Assess the Efficacy and Safety of NFC-1 in Adolescents (Ages 12-17) With Genetic Disorders Impacting Metabotropic Glutamate Receptors and ADHD
Aevi Genomic Medicine, LLC, a Cerecor company·interventional·Posted May 19, 2016·Updated Aug 11, 2021
In Brief
A Phase 3 clinical trial evaluating NFC-1 and Placebo for Attention Deficit Disorder With Hyperactivity. Completed, enrolled 101 participants across 1 site.
Detailed Summary
This is a randomized, double-blind, placebo-controlled, parallel-group study of NFC-1 versus placebo in adolescents with ADHD who have genetic disorders impacting mGluRs.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedMay 2016
Enrollment StartJun 2016
Primary CompletionFeb 2017
Study CompletionFeb 2017
TodayJul 2026
First PostedMay 19, 2016
Enrollment StartJun 1, 2016
Primary CompletionFeb 10, 2017
Study CompletionFeb 17, 2017
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 10.1 years ago
Interventions
NFC-1drug
NFC-1 is supplied as size 2 hard gelatin capsules.
Placebodrug
Matching placebo capsules