Status:
COMPLETED
A Trial Evaluating the Efficacy and Safety of HLD200 in Children With ADHD
Lead Sponsor:
Ironshore Pharmaceuticals and Development, Inc
Conditions:
Attention Deficit Hyperactivity Disorder
Eligibility:
All Genders
6-12 years
Phase:
PHASE3
Brief Summary
This study will examine the efficacy and safety of HLD200 in patients age 6-12 years with ADHD using a classroom study design.
Detailed Description
The study consists of two distinct treatment phases. The first is the 6-week open-label, treatment optimization phase during which subjects are titrated to an optimal daily dose of HLD200. Subjects ar...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
May 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT02255513
Start Date
May 1 2014
End Date
October 1 2014
Last Update
June 30 2021
Active Locations (4)
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1
AVIDA, Inc.
Newport Beach, California, United States, 92660
2
South Shore Psychiatric Services, PC
Marshfield, Massachusetts, United States, 02050
3
Center for Psychiatry and Behavioral Medicine, Inc.
Las Vegas, Nevada, United States, 89128
4
Duke University Medical Center
Durham, North Carolina, United States, 27705