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.

Trial Profile

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.

Completed
Phase of Trial: Phase I/II

Latest Information Update: 12 Nov 2014

At a glance

  • Drugs Dexamfetamine (Primary)
  • Indications Attention-deficit hyperactivity disorder
  • Focus Pharmacokinetics
  • Sponsors Ironshore Pharmaceutical and Development
  • Most Recent Events

    • 01 Sep 2013 Status changed from recruiting to completed as reported by ClinicalTrials.gov.
    • 15 Aug 2013 Dosing of adolescent patients in the phase I/II study has begun and dosing in the paediatric study is expected to begin this week, according to Highland Therapeutics.
    • 01 Jul 2013 Status changed from not yet recruiting to recruiting as reported by ClinicalTrials.gov record.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top