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

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ironshore Pharmaceuticals and Development, Inc
• Treatments: Methylphenidate

Criteria

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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).