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

NCT02255513 | Completed Phase 3 Results

• 1 other identifier: HLD200-106
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 4

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.

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

• SKAMP

  Swanson, Kotkin, Agler, M-Flynn and Pelham (SKAMP) Combined Scores - Average of 8:00 am to 4:00 pm assessments from the laboratory school day. The SKAMP is a validated, 13-item, observer-rated scale designed to assess the level of impairment of classroom-observed behaviors (Wigal and Wigal, 2006). Items 1 through 4 assess subject attention; items 5 through 8 assess deportment; items 9 through 11 assess quality of work; while items 12 and 13 assess subject compliance with teacher/classroom rules. Each individual item is rated on a 7-point scale from 0 (normal, no impairment) to 6 (maximal impairment). When all individual item scores are summed together, they produce a 13-item combined score that ranges from 0 to 78, with higher scores signifying greater impairment. In the present study, the SKAMP rating scale was utilized across 6 sessions occurring at 8:00 am, 9:00 am, 10:00 am, 12:00 pm, 2:00 pm, 4:00 pm of the laboratory school day.

  8-hours from 8:00 am to 4:00 pm

Study Arms (2)

HLD200

EXPERIMENTAL

HLD200 (methylphenidate hydrochloride) 20, 40, 60, 80, or 100 mg capsules Subjects were allowed to titrate to their optimal HLD200 dose during a 6 week open-label, treatment optimization phase before being randomized to continue their HLD200 treatment over an one week double-blind, placebo-controlled phase. HLD200 was administered orally, once daily each evening.

Drug: HLD200

Placebo

PLACEBO COMPARATOR

Placebo capsules (dose matched to HLD200 capsules) Subjects were allowed to titrate to their optimal HLD200 dose during a 6 week open-label, treatment optimization phase before being randomized to receive placebo treatment over a one week double-blind, placebo-controlled phase. Treatments were administered orally, once daily each evening.

Drug: Placebo

Interventions

HLD200 DRUG

Also known as: methylphenidate hydrochloride (MPH)

HLD200

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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).

Sponsors & Collaborators

• Ironshore Pharmaceuticals and Development, Inc: lead

Study Sites (4)

AVIDA, Inc.

Newport Beach, California, 92660, United States

Location

South Shore Psychiatric Services, PC

Marshfield, Massachusetts, 02050, United States

Location

Center for Psychiatry and Behavioral Medicine, Inc.

Las Vegas, Nevada, 89128, United States

Location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Chief Scientific Officer
• Organization: Ironshore Pharmaceuticals and Development, Inc.

bev@ironshorepharma.com

13457498174

Study Officials

• Dr. Ann Childress, M.D.

  Center for Psychiatry And Behavioral Medicine Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2014
• First Posted: October 2, 2014
• Study Start: May 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: June 30, 2021
• Results First Posted: February 10, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)