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)
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.
2 other identifiers
interventional
22
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jul 2013
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 21, 2013
CompletedFirst Posted
Study publicly available on registry
June 26, 2013
CompletedStudy Start
First participant enrolled
July 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedOctober 3, 2014
September 1, 2014
2 months
June 21, 2013
October 2, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Rate and Extent of absorption of d-amphetamine (AUC0-tz, AUC0-∞, Cmax, Tmax, absorption lag time, λz, and t1/2elim)
48hrs
Secondary Outcomes (1)
Safety (AEs, ECG, laboratory parameters, physical examinations)
48 hours
Study Arms (2)
Adolescents (12-17yrs)
EXPERIMENTALChildren (6-11 yrs)
EXPERIMENTALInterventions
d-amphetamine sulfate capsules, 30 mg, CII (25% SR, 30% pH coat, slow release; formulation B)
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Saskatoon Centre for Patient-Oriented Research, Royal University Hospital, Room 5681, C Wing
Saskatoon, Saskatchewan, S7N 0W8, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2013
First Posted
June 26, 2013
Study Start
July 1, 2013
Primary Completion
September 1, 2013
Study Completion
September 1, 2013
Last Updated
October 3, 2014
Record last verified: 2014-09