Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-25 @ 2:04 AM
NCT ID:
NCT01907360
Eligibility Criteria:
Inclusion Criteria:
* Male and female adolescents (13-17 years) and children (6-12 years).
* Previous diagnosis of ADHD and confirmation using the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID).
* ADHD symptoms controlled on a stable dose of ADHD medication. Subjects should be on MPH or have previous history of symptom control during treatment with MPH.
* Physical examination free of clinically significant findings, unless deemed NCS by the Investigator and Medical Monitor;
* Able to swallow treatment capsules;
* Available for entire study period;
* Provision of informed consent (from the parent\[s\] and/or legal representative\[s\]) and assent (from the subject); and
* Female subjects of childbearing potential (i.e., post-menarche) required to have a negative result on urine pregnancy testing (and will be given specific instructions on avoiding pregnancy during trial)
Exclusion Criteria:
* Any known history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, ophthalmologic disease, unless deemed NCS by the Investigator and the Medical Monitor;
* Presence of any significant physical or organ abnormality;
* Any illness during the 4 weeks before this study, unless deemed NCS by the Investigator and the Clinical and/or Medical Monitor;
* Severe comorbid psychiatric diagnosis that may affect subject safety or confound results (e.g., psychosis, bipolar disorder);
* Known history of moderate to severe asthma;
* Known history of severe allergic reaction (including drugs, food, insect bites, environmental allergens);
* Known history of seizures (except febrile seizures prior to age 5), anorexia nervosa, bulimia or current diagnosis or family history of Tourette's disorder;
* Subject who are severely underweight or overweight.
* Clinical value outside of the acceptable ranges, unless deemed NCS significant per the Investigator;
* Positive history for hepatitis B, hepatitis C and Human Immunodeficiency Virus (HIV);
* Positive screening for illicit drug use, and/or current health conditions or use of medications that might confound the results of the study or increase risk to the subject;
* Use of prescription medications (except ADHD medications) within 7 days and over-the counter medications (except birth control) within the 3 days preceding study enrollment, unless deemed acceptable by the Investigator and Clinical and/or Medical Monitor;
* Blood draws of 50 ml to 249 ml within the 30 days, 250 ml to 449 ml within the 45 days and ≥ 450 ml within the 60 days preceding study enrollment;
* Participation in clinical trial with an investigational drug within the 30 days preceding study enrollment;
* Intolerance to venipuncture; and
* Current suicidal ideation or history of suicidality determined as a significant finding on the Columbia-Suicide Severity Rating Scale (C-SSRS) by the investigator (Baseline C-SSRS for adolescents; Pediatric Baseline C-SSRS for children).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
17 Years
Study:
NCT01907360
Study Brief:
Protocol Section:
NCT01907360