6 completed, 1 terminated. 4 Phase 3, 3 Phase 2, 2 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 4 | Completed 3, Terminated 1 |
| Phase 2 | 3 | Completed 3 |
| Phase 1 | 2 | Completed 2 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Efficacy, Safety & Pharmacokinetic (PK) Study of HLD200 in Children Aged 4-5 Years With ADHD HLD200 methylphenidate hydrochloride capsules, Placebo HLD200 capsules - Attention Deficit Hyperactivity Disorder | Phase 3 | Terminated | Ironshore Pharmaceuticals and Development, Inc | 26 | 2024-09-13 | 2025-11-06 |
| A Study of Delayed and Extended Release Formulation of Dextroamphetamine Sulfate (HLD100) in Children With ADHD HLD100 - Attention-Deficit Hyperactivity Disorder (ADHD) | Phase 2 | Completed | Ironshore Pharmaceuticals and Development, Inc | 22 | 2016-08-01 | 2021-07-19 |
| A Pivotal Efficacy Trial to Evaluate HLD200 in Children With ADHD in a Naturalistic Setting HLD200 methylphenidate hydrochloride (MPH) Capsules, Placebo - Attention Deficit Hyperactivity Disorder | Phase 3 | Completed | Ironshore Pharmaceuticals and Development, Inc | 163 | 2015-08-01 | 2021-07-23 |
| A Pivotal Efficacy Trial to Evaluate HLD200 in Children With ADHD in a Classroom Setting HLD200 methylphenidate hydrochloride (MPH) Capsules, Placebo - Attention Deficit Hyperactivity Disorder | Phase 3 | Completed | Ironshore Pharmaceuticals and Development, Inc | 125 | 2015-07-01 | 2021-07-23 |
| A Trial Evaluating the Efficacy and Safety of HLD200 in Children With ADHD HLD200, Placebo - Attention Deficit Hyperactivity Disorder | Phase 3 | Completed | Ironshore Pharmaceuticals and Development, Inc | 43 | 2014-05-01 | 2021-06-30 |
| Pharmacokinetics of HLD200 in Children and Adolescents With ADHD HLD200 (methylphenidate hydrochloride) - Attention-Deficit Hyperactivity Disorder | Phase 1 / Phase 2 | Completed | Ironshore Pharmaceuticals and Development, Inc | 29 | 2013-08-01 | 2021-12-23 |
| 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) HLD100-B, HLD100-C, HLD100-E - Attention-Deficit Hyperactivity Disorder | Phase 1 / Phase 2 | Completed | Ironshore Pharmaceuticals and Development, Inc | 22 | 2013-07-01 | 2014-10-03 |
Attention Deficit Disorder with Hyperactivity (7)
Methylphenidate (5) · 5,10-dihydro-5-methylphenazine (2) · Capsules (2) · Dextroamphetamine (1)
United States (6) · Canada (1)
Ann Childress, MD (2) · Ann Childress, M.D. (1) · Dr. Ann Childress, M.D. (1) · Newcorn Jeffrey, MD (1)
PMID 36971690, PMID 41342306, PMID 29039979, PMID 31464511, PMID 33168234, PMID 33797983, PMID 34085581, PMID 34166587, PMID 34166588, PMID 34166589, PMID 37770309