Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HLD100-B · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Adolescents (12-17yrs) | EXPERIMENTAL | - |
| Children (6-11 yrs) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| HLD100-B | DRUG | d-amphetamine sulfate capsules, 30 mg, CII (25% SR, 30% pH coat, slow release; formulation B) |
| HLD100-C | DRUG | d-amphetamine sulfate capsules, 30 mg, CII (20% SR, 20% pH coat, fast release; formulation E) - this intervention may be deemed unnecessary based on results from Intervention 1. |
| HLD100-E | DRUG | d-amphetamine sulfate capsules, 30 mg, CII (20% SR, 20% pH coat, medium release; formulation E) - this intervention may be deemed unnecessary based on results from Interventions 1 and 2. |
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 Dexedr...
HLD100-B is an investigational modified-release amphetamine formulation being developed by Collegium Pharmaceutical, Inc. for Attention-Deficit Hyperactivity Disorder (ADHD). It is a small molecule in Phase 1 clinical development and has not been approved by the FDA. It was studied in pediatric and adolescent ADHD patients.
HLD100-B is being developed for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD) in children and adolescents. It is an investigational modified-release amphetamine formulation and is not approved for any indication. Its only recorded clinical study enrolled 22 participants aged 6 years and older with ADHD.
HLD100-B is being developed by Collegium Pharmaceutical, Inc., which trades on the Nasdaq under the ticker COLL. The company sponsored the Phase 1 trial of the modified-release amphetamine formulation in pediatric and adolescent patients with Attention-Deficit Hyperactivity Disorder.
HLD100-B is in Phase 1 clinical development. One trial has been completed, and no trials are currently active. The program is investigational and has not received FDA approval. The completed study enrolled 22 participants and was conducted in Canada.
HLD100-B has been evaluated in one completed clinical trial, NCT01886469. Titled a Phase II adaptive trial, it examined the pharmacokinetic and pharmacodynamic effects of modified-release amphetamine formulations, including HLD100-B, in children and adolescents with Attention-Deficit Hyperactivity Disorder. The study enrolled 22 participants in Canada and is no longer active.