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NCT Number: NCT01886469

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)

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.

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Key information

Conditions

Attention-Deficit Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Saskatoon Centre for Patient-Oriented Research, Royal University Hospital, Room 5681, C Wing

Saskatoon, Saskatchewan, S7N 0W8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HLD100-B

Drug

d-amphetamine sulfate capsules, 30 mg, CII (25% SR, 30% pH coat, slow release; formulation B)

HLD100-C

Drug

d-amphetamine sulfate capsules, 30 mg, CII (20% SR, 20% pH coat, fast release; formulation E) - this intervention may be deemed unnecessary based on results from Intervention 1.

HLD100-E

Drug

d-amphetamine sulfate capsules, 30 mg, CII (20% SR, 20% pH coat, medium release; formulation E) - this intervention may be deemed unnecessary based on results from Interventions 1 and 2.

Primary outcomes

  1. Rate and Extent of absorption of d-amphetamine (AUC0-tz, AUC0-∞, Cmax, Tmax, absorption lag time, λz, and t1/2elim)

    Time frame: 48hrs

Secondary outcomes

  1. Safety (AEs, ECG, laboratory parameters, physical examinations)

    Time frame: 48 hours

Sponsors and collaborators

Lead sponsor

Ironshore Pharmaceuticals and Development, Inc

Other

Registry information

Official study title

A Phase II, Two-Stage, Open-Label, Single-Treatment, Adaptive Trial Design Examining the Pharmacokinetic and Pharmacodynamic Effects of up to Three Separate HLD100 Modified Release Formulations of Dextroamphetamine Sulfate in Adolescent (Stage 1) and Pediatric (Stage 2) Patients With Attention-Deficit Hyperactivity Disorder.

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jun 26, 2013
Registry last updated
Oct 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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