A Trial Evaluating the Efficacy and Safety of HLD200 in Children With ADHD

Completed · Phase 3 · Has a placebo group

Conditions studied: Attention Deficit Hyperactivity Disorder

In brief

This study will examine the efficacy and safety of HLD200 in patients age 6-12 years with ADHD using a classroom study design.

Key facts

Study ID

NCT02255513

Run by

Ironshore Pharmaceuticals and Development, Inc

People needed

43

Starts

2014-05-01

Expected to finish

2014-10-01

Last updated by the study team

2021-06-30

Who can join

Age: 6 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female children (6-12 years at study entry)
• Previous diagnosis of ADHD and confirmation using the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID)
• 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)
• Female subjects of childbearing potential (i.e., post-menarche) required to have a negative result on urine pregnancy test (and will be given specific instructions for avoiding pregnancy during trial).

You may not qualify if…

• Any known history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, ophthalmologic disease
• Presence of any significant physical or organ abnormality
• Any illness during the 4 weeks before this study
• Comorbid psychiatric diagnosis that may affect subject safety or confound results (e.g., psychosis, bipolar disorder)
• Known history of severe asthma (in the opinion of the investigator) unless deemed currently controlled
• Known history of severe allergic reaction to MPH
• 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 (in the opinion of the Investigator)
• Any clinical laboratory value outside of the acceptable ranges, unless deemed NCS significant per the Investigator
• Positive history for hepatitis B, hepatitis C or 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 or Medical Monitor
• Participation in clinical trial with an investigational drug within the 30 days preceding study enrollment
• Current suicidal ideation or history of suicidality determined as a significant finding on the C-SSRS by the investigator (Baseline C-SSRS for adolescents; Pediatric Baseline C-SSRS for children).

Where it is running

• AVIDA, Inc. — Newport Beach, California, United States
• South Shore Psychiatric Services, PC — Marshfield, Massachusetts, United States
• Center for Psychiatry and Behavioral Medicine, Inc. — Las Vegas, Nevada, United States
• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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