Status:
COMPLETED
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)
Lead Sponsor:
Ironshore Pharmaceuticals and Development, Inc
Conditions:
Attention-Deficit Hyperactivity Disorder
Eligibility:
All Genders
6-17 years
Phase:
PHASE1
PHASE2
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01886469
Start Date
July 1 2013
End Date
September 1 2013
Last Update
October 3 2014
Active Locations (1)
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1
Saskatoon Centre for Patient-Oriented Research, Royal University Hospital, Room 5681, C Wing
Saskatoon, Saskatchewan, Canada, S7N 0W8