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)

Attention-Deficit Hyperactivity Disorder Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01886469
• Other study ID #: HLD100-102
• Secondary ID: HLD100-102 (Cont
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: June 21, 2013
• Last updated: October 2, 2014
• Start date: July 2013
• Est. completion date: September 2013

Study information

• Verified date: September 2014
• Source: Ironshore Pharmaceuticals and Development, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 17 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention-Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

Drug:
• HLD100-B
d-amphetamine sulfate capsules, 30 mg, CII (25% SR, 30% pH coat, slow release; formulation B)
• 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.
• 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.

Locations

Country	Name	City	State
Canada	Saskatoon Centre for Patient-Oriented Research, Royal University Hospital, Room 5681, C Wing	Saskatoon	Saskatchewan

Sponsors (1)

Lead Sponsor	Collaborator
Ironshore Pharmaceuticals and Development, Inc

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate and Extent of absorption of d-amphetamine (AUC0-tz, AUC0-8, Cmax, Tmax, absorption lag time, ?z, and t1/2elim)		48hrs	No
Secondary	Safety (AEs, ECG, laboratory parameters, physical examinations)		48 hours	Yes