Efficacy and Safety of NFC-1 in Adolescents With Genetic Disorders Impacting mGluR and ADHD
Status: | Completed |
---|---|
Conditions: | Psychiatric, Women's Studies |
Therapuetic Areas: | Psychiatry / Psychology, Reproductive |
Healthy: | No |
Age Range: | 12 - 17 |
Updated: | 4/27/2018 |
Start Date: | June 2016 |
End Date: | February 17, 2017 |
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
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.
placebo in adolescents with ADHD who have genetic disorders impacting mGluRs.
This is a randomized, double-blind, placebo-controlled, parallel-group study of adolescents
with ADHD who have genetic disorders impacting mGluRs. Approximately 90 subjects will receive
randomized treatment with NFC-1 or placebo. Dosing will be optimized during the first 4 weeks
of treatment, based on clinical response and tolerability, and maintained for an additional 2
weeks.
with ADHD who have genetic disorders impacting mGluRs. Approximately 90 subjects will receive
randomized treatment with NFC-1 or placebo. Dosing will be optimized during the first 4 weeks
of treatment, based on clinical response and tolerability, and maintained for an additional 2
weeks.
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 intelligence quotient (IQ) > 79, based on the Wechsler Abbreviated
Scale of Intelligence, second edition (WASI-II).
- Subject has been genotyped previously and determined to have disruptive mutations in
genes within the glutamate receptor metabotropic (GRM)-network as determined by the
presence of copy number variations (CNVs) (GRM biomarker-positive subjects). The
confirmation of a subject's positive status will be provided by the sponsor.
- Subject is judged to be in general good health, other than having ADHD, based on
medical history, physical examination, vital signs measurements, laboratory safety
tests, and the Columbia Suicide Severity Rating Scale (C-SSRS) performed at the
Screening Visit and/or prior to administration of investigational product (IP).
- Subject has no clinically significant abnormality on electrocardiogram (ECG) performed
at the Screening Visit and/or prior to administration of IP such as serious
arrhythmia, bradycardia, tachycardia, cardiac conduction problems, or other
abnormalities deemed to be a potential safety issue.
- Parent/legal guardian and subject understand the study procedures and agree to the
subject's participation in the study as indicated by parental/legal guardian signature
on the subject informed consent form and subject signature on the assent form.
Exclusion Criteria:
- Subjects with prior diagnosis of comorbid major psychiatric disorders (ie, aside from
ADHD), including major depression, bipolar disease, schizophrenia, pervasive
development disorder, and intellectual disability.
- Subject is currently taking a prohibited medication and/or is unwilling to wean off
current ADHD medication to participate in the study
- Subject has a history of any illness that in the opinion of the study investigator
might confound the results of the study or poses an additional risk to the subject by
his or her participation in the study.
- Subject has a known history or presence of syncope, cardiac conduction problems (eg,
clinically significant heart block), exercise-related cardiac events including syncope
and pre-syncope, or clinically significant bradycardia.
- Subject has a history of stroke, chronic seizures, or major neurological disorder
which, in the opinion of the investigator, would interfere with the subject's ability
to participate and/or be evaluated in the study.
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