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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

Tracking Information
First Submitted Date  ICMJE June 21, 2013
First Posted Date  ICMJE June 26, 2013
Last Update Posted Date October 3, 2014
Study Start Date  ICMJE July 2013
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2013)
Rate and Extent of absorption of d-amphetamine (AUC0-tz, AUC0-∞, Cmax, Tmax, absorption lag time, λz, and t1/2elim) [ Time Frame: 48hrs ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01886469 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2013)
Safety (AEs, ECG, laboratory parameters, physical examinations) [ Time Frame: 48 hours ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Attention-Deficit Hyperactivity Disorder
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Adolescents (12-17yrs)
    Interventions:
    • Drug: HLD100-B
    • Drug: HLD100-C
    • Drug: HLD100-E
  • Experimental: Children (6-11 yrs)
    Interventions:
    • Drug: HLD100-B
    • Drug: HLD100-C
    • Drug: HLD100-E
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 9, 2013)
22
Original Estimated Enrollment  ICMJE
 (submitted: June 25, 2013)
96
Actual Study Completion Date  ICMJE September 2013
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01886469
Other Study ID Numbers  ICMJE HLD100-102
HLD100-102 (Control # 163513) ( Other Identifier: Health Canada )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ironshore Pharmaceuticals and Development, Inc
Study Sponsor  ICMJE Ironshore Pharmaceuticals and Development, Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ironshore Pharmaceuticals and Development, Inc
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP