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)

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

Tracking Information

• First Submitted Date: June 21, 2013
• First Posted Date: June 26, 2013
• Last Update Posted Date: October 3, 2014
• Study Start Date: July 2013
• Actual Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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: Same as current
• Change History: Complete list of historical versions of study NCT01886469 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures (submitted: June 25, 2013): Safety (AEs, ECG, laboratory parameters, physical examinations) [ Time Frame: 48 hours ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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: 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: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Attention-Deficit Hyperactivity Disorder

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 9, 2013): 22
• Original Estimated Enrollment (submitted: June 25, 2013): 96
• Actual Study Completion Date: September 2013
• Actual Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 6 Years to 17 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT01886469
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: Ironshore Pharmaceuticals and Development, Inc
• Study Sponsor: Ironshore Pharmaceuticals and Development, Inc
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Ironshore Pharmaceuticals and Development, Inc
• Verification Date: September 2014