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)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01886469 |
Recruitment Status :
Completed
First Posted : June 26, 2013
Last Update Posted : October 3, 2014
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Attention-Deficit Hyperactivity Disorder | Drug: HLD100-B Drug: HLD100-C Drug: HLD100-E | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
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 : | July 2013 |
Actual Primary Completion Date : | September 2013 |
Actual Study Completion Date : | September 2013 |

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. |
- Rate and Extent of absorption of d-amphetamine (AUC0-tz, AUC0-∞, Cmax, Tmax, absorption lag time, λz, and t1/2elim) [ Time Frame: 48hrs ]
- Safety (AEs, ECG, laboratory parameters, physical examinations) [ Time Frame: 48 hours ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 6 Years to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01886469
Canada, Saskatchewan | |
Saskatoon Centre for Patient-Oriented Research, Royal University Hospital, Room 5681, C Wing | |
Saskatoon, Saskatchewan, Canada, S7N 0W8 |
Responsible Party: | Ironshore Pharmaceuticals and Development, Inc |
ClinicalTrials.gov Identifier: | NCT01886469 |
Other Study ID Numbers: |
HLD100-102 HLD100-102 (Control # 163513) ( Other Identifier: Health Canada ) |
First Posted: | June 26, 2013 Key Record Dates |
Last Update Posted: | October 3, 2014 |
Last Verified: | September 2014 |
Hyperkinesis Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Neurodevelopmental Disorders |
Mental Disorders Dyskinesias Neurologic Manifestations Nervous System Diseases |