Back to resultsA 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)
Primary Purpose
Attention-Deficit Hyperactivity Disorder
Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
HLD100-B
HLD100-C
HLD100-E
Sponsored by
About this trial
This is an interventional treatment trial for Attention-Deficit Hyperactivity Disorder
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.
Sites / Locations
- Saskatoon Centre for Patient-Oriented Research, Royal University Hospital, Room 5681, C Wing
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Adolescents (12-17yrs)
Children (6-11 yrs)
Arm Description
Outcomes
Primary Outcome Measures
Rate and Extent of absorption of d-amphetamine (AUC0-tz, AUC0-∞, Cmax, Tmax, absorption lag time, λz, and t1/2elim)
Secondary Outcome Measures
Safety (AEs, ECG, laboratory parameters, physical examinations)
Full Information
NCT ID
NCT01886469
First Posted
June 21, 2013
Last Updated
October 2, 2014
Sponsor
Ironshore Pharmaceuticals and Development, Inc
1. Study Identification
Unique Protocol Identification Number
NCT01886469
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.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ironshore Pharmaceuticals and Development, Inc
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention-Deficit Hyperactivity Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Adolescents (12-17yrs)
Arm Type
Experimental
Arm Title
Children (6-11 yrs)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
HLD100-B
Intervention Description
d-amphetamine sulfate capsules, 30 mg, CII (25% SR, 30% pH coat, slow release; formulation B)
Intervention Type
Drug
Intervention Name(s)
HLD100-C
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
HLD100-E
Intervention Description
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 Measure Information:
Title
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 Measure Information:
Title
Safety (AEs, ECG, laboratory parameters, physical examinations)
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Saskatoon Centre for Patient-Oriented Research, Royal University Hospital, Room 5681, C Wing
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
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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