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)

I

Ironshore Pharmaceuticals and Development, Inc

Status and phase

Completed
Phase 2
Phase 1

Conditions

Attention-Deficit Hyperactivity Disorder

Treatments

Drug: HLD100-B
Drug: HLD100-E
Drug: HLD100-C

Study type

Interventional

Funder types

Other

Identifiers

NCT01886469
HLD100-102 (Control # 163513) (Other Identifier)
HLD100-102

Details and patient eligibility

About

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.

Enrollment

22 patients

Sex

All

Ages

6 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

22 participants in 2 patient groups

Adolescents (12-17yrs)
Experimental group
Treatment:
Drug: HLD100-C
Drug: HLD100-E
Drug: HLD100-B
Children (6-11 yrs)
Experimental group
Treatment:
Drug: HLD100-C
Drug: HLD100-E
Drug: HLD100-B

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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