Phase II, Open-label, Dose-titration, Safety Study Designed to Determine the Evening Dose of a Novel Delayed and Extended Release Formulation of Dextroamphetamine Sulfate (HLD100) to Produce Optimal Clinical Effects in Children With ADHD
Latest Information Update: 20 Jul 2021
At a glance
- Drugs Dexamfetamine (Primary)
- Indications Attention-deficit hyperactivity disorder
- Focus Adverse reactions
- Sponsors Ironshore Pharmaceutical and Development
- 20 Jun 2051 Study design is changed from single group assignment to sequential assignment.
- 19 Sep 2017 Status changed from active, no longer recruiting to completed.
- 12 Apr 2017 According to an Ironshore Pharmaceutical and Development Media Release, results from this trial were reviewed at an End of Phase 2 meeting with the FDA and based on the feedback company is pursuing for two pivotal Phase 3 studies (see profile 276138 and 269841).