A Phase II, Adaptive Trial Design Examining the Pharmacok... | NCT01886469

Studies
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)

NCT01886469

Sponsor

Ironshore Pharmaceuticals and Development, Inc

Status

Completed

Last Update Posted

Oct 3, 2014Estimated

Enrollment

22Actual

Phase

Phase 1Phase 2

Conditions

Attention-Deficit Hyperactivity Disorder

Interventions

HLD100-B
HLD100-C
HLD100-E

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
HLD100-102 (Control # 163513)	Other Identifier	Health Canada

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.

Status Module

Record Verification Date

Sep 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2013

Primary Completion Date

Sep 2013Actual

Completion Date

Sep 2013Actual

First Submitted Date

Jun 21, 2013

First Submission Date that Met QC Criteria

Jun 25, 2013

First Posted Date

Jun 26, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 2, 2014

Last Update Posted Date

Oct 3, 2014Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Adolescents (12-17yrs)	Experimental		Drug: HLD100-B Drug: HLD100-C Drug: HLD100-E
Children (6-11 yrs)	Experimental		Drug: HLD100-B Drug: HLD100-C Drug: HLD100-E

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HLD100-B	Drug	d-amphetamine sulfate capsules, 30 mg, CII (25% SR, 30% pH coat, slow release; formulation B)	Adolescents (12-17yrs) Children (6-11 yrs)

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Safety (AEs, ECG, laboratory parameters, physical examinations)		48 hours

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Saskatoon Centre for Patient-Oriented Research, Royal University Hospital, Room 5681, C Wing		Saskatoon	Saskatchewan	S7N 0W8	Canada

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D019958	Attention Deficit and Disruptive Behavior Disorders
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders