Overview

A Phase II, Adaptive Trial Design Examining the Pharmacokinetic and Pharmacodynamic Effects of Modified Release Amphetamine (HLD100, Formulations B, C and E)) in Adolescents and Children With Attention-Deficit Hyperactivity Disorder (ADHD)

Status:
Completed
Trial end date:
2013-09-01
Target enrollment:
0
Participant gender:
All
Summary
The main purpose of this study is to determine the rate and extent of absorption of one or more modified release formulations of amphetamine (HLD100) in both adolescents and children with ADHD.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ironshore Pharmaceuticals and Development, Inc
Treatments:
Amphetamine
Criteria
Main Inclusion Criteria

- Male and female adolescents (12-17 years; Stage 1) and children (6-11 years; Stage 2).

- Diagnosis of ADHD and confirmed on Kiddie-Schedule for Affective Disorders and
Schizophrenia (K-SADS).

- ADHD symptoms controlled on a stable dose of Vyvanse, Adderall XR and or Dexedrine.

- Provision of informed consent (from parent[s] or legal representative[s]) and assent
(from subject) for patients.

Main Exclusion Criteria

- Comorbid psychiatric diagnosis (e.g., psychosis, bipolar disorder).

- History of seizures or current diagnosis or family history of Tourette's disorder.

- Use of prescription drugs (except Vyvanse, Dexedrine or Adderall XR) the 14 days and
over-the-counter drugs (except birth control) the 30 days before the study.