Phase
Condition
Attention Deficit/hyperactivity Disorder (Adhd - Adults)
Williams Syndrome
Treatment
NRCT-101SR
Clinical Study ID
Ages 13-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female, 13-17 years of age at screening.
Has a primary diagnosis of ADHD according to the DSM-5 classification, confirmedwith MINI using DSM-5 probes.
ADHD-related symptoms - ADHD-RS-5 ≥ 26 in screening and baseline.
- Baseline score must not change by more than 25% from screening to baseline, exceptsubjects who stop taking ADHD medication after screening may have an increase ofmore than 25%.
- Has a minimum score of 4 on the CGI-S at baseline.
Exclusion
Exclusion Criteria:
PERMP-C score > 200 in Moderate difficulty level in orientation.
PERMP-C score > 180 in Easy difficulty level AND < 80 in Moderate difficulty levelin orientation.
Subject is functioning below an age-appropriate level intellectually, as judged bythe Investigator.
Lifetime history of severe psychiatric symptoms of major depression requiringhospitalization, bipolar disorder, schizophrenia or schizoaffective disorder,hallucinations, or delusions. Severe comorbid disorders such as PTSD, severeobsessive-compulsive disorder, or other symptomatic presentation that, in theopinion of the examining physician, will contraindicate NRCT-101SR treatment orconfound efficacy or safety assessments. Subjects with mild to moderate forms ofsocial phobia or dysthymia, for instance, may be included.
History of seizures (other than infantile febrile seizures), any tic disorder (except transient tic disorder and subject has no episodes for at least 1 year), ora current diagnosis of Tourette's Disorder.
Recent history (within the past 1 year) of suspected substance abuse or dependencedisorder in accordance with DSM-5 criteria.
Current abnormal thyroid function as defined as abnormal screening thyroidstimulating hormone. Treatment for at least 3 months with a stable dose of thyroidmedication is permitted.
History of poor kidney function; corrected estimated glomerular filtration rate (eGFR) < 90 mL/min/m2
History of significant gastrointestinal disorders, such as chronic diarrhea,irritable bowel syndrome, ulcerative colitis, Crohn's disease, etc.
Female subjects who are pregnant and/or lactating and/or sexually active women ofchildbearing potential (WOCBP) not agreeing to use birth control methods outlined ininclusion criterion.
*A woman is considered fertile following menarche unless permanently sterile; apremenarchal female is not considered a WOBCP).
A "yes" answer to "suicidal ideation" item 4 (active suicidal ideation with someintent to act, without specific plan) or item 5 (active suicidal ideation withspecific plan and intent) on the C-SSRS assessment at screening (in the past 12months).
Has history of severe drug allergy or hypersensitivity to the study medication orits excipients.
Hypermagnesemia; serum magnesium > 2.5 mg/dL.
Hepatic impairment as defined by serum AST, ALT and/or ALP > 1.25 ULN, and/or serumbilirubin > 1.5 ULN.
Known history of hepatitis B and/or C.:
Is currently participating in another clinical trial or has participated in aclinical trial within 30 days or 5 half-lives of the investigational drug, whicheveris longer, prior
to the Screening Visit.
Currently living in an institutional facility.
Severe physical disability not associated with cognitive function that limitsability to complete testing.
Known history of symptomatic cardiac disease, advanced atherosclerosis, structuralcardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronaryheart disease, transient ischemic attack or stroke or other serious cardiacproblems.
Known family history of sudden cardiac death or ventricular arrhythmia.
Serious or unstable clinically important systemic illness or disease that, in thejudgment of the Investigator, is likely to affect the study assessments,deteriorate, or affect the subject's safety or ability to complete the study,including hepatic (e.g., Child-Pugh grade C), renal, gastroenterological,respiratory, cardiovascular, endocrinologic, immunologic, infectious, or hematologicdisorders.
Has previously participated in a NRCT-101SR / L-TAMS investigational study.
Investigators and their immediate family members are not permitted to participate inthe study.
Changes in medications or doses of medication as follows:
All allowed concomitant medications, supplements, or other substances must be atstable doses for at least 30 days prior to screening and must be kept as stable asmedically possible during the trial. For allowed concomitant medications, any dosingchange within 30 days of Screening may be allowed if, in the opinion of theInvestigator, it will not affect or influence study results.
Study Design
Study Description
Connect with a study center
Advanced Research Center, Inc
Anaheim, California 92805
United StatesActive - Recruiting
Accel Research Sites - Lakeland Clinical Research Unit
Lakeland, Florida 33803
United StatesActive - Recruiting
Accel Research Sites
Maitland, Florida 32751
United StatesActive - Recruiting
Accel Research Sites Network - Maitland
Maitland, Florida 32751
United StatesActive - Recruiting
Bio-Medical Research LLC
Miami, Florida 33144
United StatesActive - Recruiting
CenExel ACMR Atlanta Center for Medical Research
Atlanta, Georgia 30331
United StatesActive - Recruiting
iResearch Atlanta
Decatur, Georgia 30030
United StatesActive - Recruiting
iRresearch Atlanta
Decatur, Georgia 30030
United StatesActive - Recruiting
CenExel iRS - iResearch Savannah
Savannah, Georgia 31405
United StatesActive - Recruiting
DelRicht Research
New Orleans, Louisiana 70155
United StatesSite Not Available
DelRicht Research
Prairieville, Louisiana 70769
United StatesActive - Recruiting
Boston Clinical Trials Llc
Boston, Massachusetts 02131
United StatesActive - Recruiting
Center for Psychiatry and Behavioral Medicine
Las Vegas, Nevada 89128
United StatesSite Not Available
Vector Clinical Trials
Las Vegas, Nevada 89128
United StatesActive - Recruiting
Coastal Carolina Research Center - North Charleston
North Charleston, South Carolina 29405
United StatesActive - Recruiting
Epic Medical Research - DeSoto
DeSoto, Texas 75115
United StatesActive - Recruiting
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