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)

Sponsor

Ironshore Pharmaceuticals and Development, Inc (Other)

Overall Status

Completed

CT.gov ID

NCT01886469

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

10.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Attention-Deficit Hyperactivity Disorder	Drug: HLD100-B Drug: HLD100-C Drug: HLD100-E	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

22 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Jul 1, 2013

Actual Primary Completion Date :

Sep 1, 2013

Actual Study Completion Date :

Sep 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Adolescents (12-17yrs)	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.
Experimental: Children (6-11 yrs)	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.

Arm

Intervention/Treatment

Experimental: Adolescents (12-17yrs)

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.

Experimental: Children (6-11 yrs)

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.

Outcome Measures

Primary Outcome Measures

Rate and Extent of absorption of d-amphetamine (AUC0-tz, AUC0-∞, Cmax, Tmax, absorption lag time, λz, and t1/2elim) [48hrs]

Secondary Outcome Measures

Safety (AEs, ECG, laboratory parameters, physical examinations) [48 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Saskatoon Centre for Patient-Oriented Research, Royal University Hospital, Room 5681, C Wing	Saskatoon	Saskatchewan	Canada	S7N 0W8

Sponsors and Collaborators

Ironshore Pharmaceuticals and Development, Inc

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ironshore Pharmaceuticals and Development, Inc

ClinicalTrials.gov Identifier:

NCT01886469

Other Study ID Numbers:

HLD100-102
HLD100-102 (Control # 163513)

First Posted:

Jun 26, 2013

Last Update Posted:

Oct 3, 2014

Last Verified:

Sep 1, 2014

Additional relevant MeSH terms:

Hyperkinesis

Attention Deficit Disorder with Hyperactivity

Study Results

No Results Posted as of Oct 3, 2014