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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)

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ClinicalTrials.gov Identifier: NCT01886469
Recruitment Status : Completed
First Posted : June 26, 2013
Last Update Posted : October 3, 2014
Sponsor:
Information provided by (Responsible Party):
Ironshore Pharmaceuticals and Development, Inc

Brief 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.

Condition or disease Intervention/treatment Phase
Attention-Deficit Hyperactivity Disorder Drug: HLD100-B Drug: HLD100-C Drug: HLD100-E Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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.
Study Start Date : July 2013
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013


Arm Intervention/treatment
Experimental: Adolescents (12-17yrs) Drug: HLD100-B
d-amphetamine sulfate capsules, 30 mg, CII (25% SR, 30% pH coat, slow release; formulation B)

Drug: HLD100-C
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.

Drug: HLD100-E
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.

Experimental: Children (6-11 yrs) Drug: HLD100-B
d-amphetamine sulfate capsules, 30 mg, CII (25% SR, 30% pH coat, slow release; formulation B)

Drug: HLD100-C
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.

Drug: HLD100-E
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 Outcome Measures :
  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 Outcome Measures :
  1. Safety (AEs, ECG, laboratory parameters, physical examinations) [ Time Frame: 48 hours ]


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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01886469


Locations
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Canada, Saskatchewan
Saskatoon Centre for Patient-Oriented Research, Royal University Hospital, Room 5681, C Wing
Saskatoon, Saskatchewan, Canada, S7N 0W8
Sponsors and Collaborators
Ironshore Pharmaceuticals and Development, Inc

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Responsible Party: Ironshore Pharmaceuticals and Development, Inc
ClinicalTrials.gov Identifier: NCT01886469     History of Changes
Other Study ID Numbers: HLD100-102
HLD100-102 (Control # 163513) ( Other Identifier: Health Canada )
First Posted: June 26, 2013    Key Record Dates
Last Update Posted: October 3, 2014
Last Verified: September 2014

Additional relevant MeSH terms:
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Disease
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Amphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors