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HLD100 · 1 trial · 1 indication
Primary outcome is the determination of the dose achieving optimal clinical effect in a safe and tolerable manner
| Arm | Type | Description |
|---|---|---|
| HLD100 10mg | EXPERIMENTAL | HLD100 (dextroamphetamine sulfate) DR/ER capsules (10mg) |
| HLD100 20mg | EXPERIMENTAL | HLD100 (dextroamphetamine sulfate) DR/ER capsules (20mg) |
| HLD100 30mg | EXPERIMENTAL | HLD100 (dextroamphetamine sulfate) DR/ER capsules (30mg) |
| HLD100 40mg | EXPERIMENTAL | HLD100 (dextroamphetamine sulfate) DR/ER capsules (40mg) |
| Name | Type | Description |
|---|---|---|
| HLD100 | DRUG | Treatment |
Inclusion Criteria: * Subjects must have a diagnosis of ADHD as defined by DSM-5 criteria with confirmation using the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID). * Subjects must demonstrate mild-to-moderate impairment of ADHD symptoms and function per the ...
HLD100 is an investigational small molecule being studied for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD). It is a delayed and extended release formulation of dextroamphetamine sulfate, designed for use in children with ADHD. The drug is currently in Phase 2 clinical development.
HLD100 is a delayed and extended release formulation of dextroamphetamine sulfate. Dextroamphetamine is a central nervous system stimulant that works by increasing the activity of certain neurotransmitters in the brain, which helps improve attention and reduce impulsivity and hyperactivity in patients with ADHD.
HLD100 is being developed by Collegium Pharmaceutical, Inc., a company traded on the stock exchange under the ticker symbol COLL. Collegium is a specialty pharmaceutical company focused on the development of products for the treatment of pain and other conditions.
HLD100 is in Phase 2 clinical development. It has completed one Phase 2 clinical trial, which was a controlled study of the drug in children with ADHD. The drug is still investigational and has not been approved by regulatory authorities for commercial use.
HLD100 has been studied in one clinical trial, identified as NCT02884544. This was a Phase 2 study titled 'A Study of Delayed and Extended Release Formulation of Dextroamphetamine Sulfate (HLD100) in Children With ADHD'. The trial was completed in the United States and enrolled 22 participants.
HLD100 is a specific delayed and extended release formulation of dextroamphetamine sulfate. While dextroamphetamine sulfate is the active pharmaceutical ingredient, HLD100 refers to the proprietary formulation developed by Collegium Pharmaceutical that is designed to provide a delayed and extended release profile.