Phase
Condition
Attention Deficit/hyperactivity Disorder (Adhd - Adults)
Williams Syndrome
Treatment
NRCT-101-SR
Placebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female, ≥ 18 years of age at screening
Has a primary diagnosis of ADHD according to the Diagnostic and Statistical Manual,Fifth Edition (DSM-5) classification, confirmed with Mini InternationalNeuropsychiatric Interview (MINI) using DSM-5 probes
AISRS ≥ 26 at screening and baseline, and does not change by more than 25% fromscreening to baseline, except subjects who stop taking ADHD medication afterscreening may have an increase of more than 25%
Has a minimum score of 4 on the CGI-S at baseline
Must be fluent in English, and capable of reading, writing, and communicatingeffectively with others and willing to participate in laboratory classroom
Completion of at least 10 years of formal education
Hearing and Vision ability sufficient to complete cognitive testing, ininvestigator's opinion
Willing and able to give informed consent
Total Body weight (bw) must be ≥ 50 kg and ≤ 105 kg and lean body mass (LBM) must be ≤ 75 kg at screening
Naïve to stimulant or non-stimulant medications used for the treatment of ADHD orhave discontinued stimulants at least 2 weeks and non-stimulants at least 3 weeksprior to randomization
Exclusion
Exclusion Criteria:
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 of 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 (excluding stable nicotine use) in accordance with DSM-5 criteria. (Note:subject's average nicotine use should not be exceeded during each LC visit)
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.
Poor kidney function; corrected estimated glomerular filtration rate (eGFRcorr) < 40mL/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
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 Columbia-Suicide Severity Rating Scale (C-SSRS)assessment at screening (in the past 12 months).
Has history of severe drug allergy or hypersensitivity to the study medication orits excipients.
Hypermagnesemia; magnesium > 2.5 mg/dL
Reproduction: a. Females of childbearing potential (FOCP) must be either sexually inactiveabstinent) or, if sexually active, must agree to use one of the following acceptablebirth control methods beginning 30 days prior to the first dose of study drug andthroughout the study: i. Simultaneous use of male condom and intra-uterinecontraceptive device placed at least 4 weeks prior to first study drugadministration ii. Surgically sterile male partner iii. Simultaneous use of malecondom and diaphragm with spermicide iv. Established hormonal contraceptive b. Malesmust: i. Use 2 methods of contraception in combination if his female partner is ofchildbearing potential; this combination of contraceptive methods must be used fromthe Baseline Visit to ≥ 1 month after the last dose of study drug, or ii. Have beensurgically sterilized prior to the Screening Visit.
Is currently participating in another clinical trial or has participated in aclinical trial within 30 days prior to the Screening Visit.
Currently living in an institutional facility such as a nursing home
Severe physical disability not associated with cognitive function that limitsability to complete testing (e.g., severe tremor, debilitating arthritis, etc.)
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 cognitive assessment, deteriorate,or affect the subject's safety or ability to complete the study, including hepatic (e.g., Child-Pugh grade C), renal, gastroenterologic, respiratory, cardiovascular,endocrinologic, immunologic, infectious, or hematologic disorders
Has previously participated in a NRCT-101SR investigational study or a study thatincludes the active ingredient of NRCT-101SR
Investigators and their immediate family members are not permitted to participate inthe study.
Consumes more than a weekly average of: 2 drinks / day or more than 3 drinks in anyday for males; 1 drink / day or more than 2 drinks in any day for females
Changes in medications or doses of medication as follows:
All allowed concomitant medications, supplements, or other substances must beat stable doses for at least 30 days prior to screening and must be kept asstable as medically possible during the trial. For allowed concomitantmedications, any dosing change within 30 days of Screening may be allowed if,in the opinion of the investigator, it will not affect or influence studyresults.
Study Design
Study Description
Connect with a study center
Collaborative Neuroscience Network
Garden Grove, California 92845
United StatesSite Not Available
Accel Research Sites
Lakeland, Florida 33803
United StatesSite Not Available
Accel Research Sites
Maitland, Florida 32751
United StatesSite Not Available
Miami Dade Medical Research Institute
Miami, Florida 33176
United StatesSite Not Available
Velocity Clinical Research - Meridian
Meridian, Idaho 82642
United StatesSite Not Available
Alcanza Clinical Research Company
Boston, Massachusetts 02131
United StatesSite Not Available
Center for Psychiatry and Behavioral Medicine
Las Vegas, Nevada 89128
United StatesSite Not Available
Hassman Research Institute
Berlin, New Jersey 08009
United StatesSite Not Available
Coastal Carolina Research Center - North Charleston
North Charleston, South Carolina 29405
United StatesSite Not Available
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