Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as HLD200 (methylphenidate hydrochloride), methylphenidate hydrochloride (MPH)
HLD200 · 2 trials · 2 indications
Swanson, Kotkin, Agler, M-Flynn and Pelham (SKAMP) Combined Scores - Average of 8:00 am to 4:00 pm assessments from the laboratory school day. The SKAMP is a validated, 13-item, observer-rated scale designed to assess the level of impairment of classroom-observed behaviors (Wigal and Wigal, 2006). Items 1 through 4 assess subject attention; items 5 through 8 assess deportment; items 9 through 11 assess quality of work; while items 12 and 13 assess subject compliance with teacher/classroom rules. Each individual item is rated on a 7-point scale from 0 (normal, no impairment) to 6 (maximal impairment). When all individual item scores are summed together, they produce a 13-item combined score that ranges from 0 to 78, with higher scores signifying greater impairment. In the present study, the SKAMP rating scale was utilized across 6 sessions occurring at 8:00 am, 9:00 am, 10:00 am, 12:00 pm, 2:00 pm, 4:00 pm of the laboratory school day.
The absorption lag time for methylphenidate in plasma expressed in hours is the difference in time between the drug administration and the last time point where the drug concentration was below the limit of assay quantitation.
The maximum drug concentration of methylphenidate in plasma.
The time to reach maximum concentration of methylphenidate in plasma.
Area under the methylphenidate plasma concentration-time curve to time point tz (AUC0-tz), where tz was the last time point over the time interval with a measurable drug concentration
The area under the methylphenidate plasma concentration-time curve to infinite time
| Arm | Type | Description |
|---|---|---|
| HLD200 | EXPERIMENTAL | HLD200 (methylphenidate hydrochloride) 20, 40, 60, 80, or 100 mg capsules Subjects were allowed to titrate to their optimal HLD200 dose during a 6 week open-label, treatment optimization phase before being randomized to continue their HLD200 treatment over an one week double-blind, placebo-controlled phase. HLD200 was administered orally, once daily each evening. |
| Placebo | PLACEBO_COMPARATOR | Placebo capsules (dose matched to HLD200 capsules) Subjects were allowed to titrate to their optimal HLD200 dose during a 6 week open-label, treatment optimization phase before being randomized to receive placebo treatment over a one week double-blind, placebo-controlled phase. Treatments were administered orally, once daily each evening. |
| HLD200 (methylphenidate hydrochloride) in Adolescents | EXPERIMENTAL | HLD200 (B formulation, 54 mg, oral capsules) administered as a single treatment in the evening to children aged 13-17 years. |
| HLD200 (methylphenidate hydrochloride) in Children | EXPERIMENTAL | HLD200 (B formulation, 54 mg, oral capsules) administered as a single treatment in the evening to children aged 6-12 years. |
| Name | Type | Description |
|---|---|---|
| HLD200 | DRUG | - |
| Placebo | DRUG | - |
| HLD200 (methylphenidate hydrochloride) | DRUG | - |
Inclusion Criteria: * Male and female children (6-12 years at study entry) * Previous diagnosis of ADHD and confirmation using the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID) * Able to swallow treatment capsules * Available for entire study period * Provisi...
HLD200 is an investigational small molecule being developed for Attention Deficit Hyperactivity Disorder (ADHD). It is also known as HLD200 (methylphenidate hydrochloride). Collegium Pharmaceutical, Inc. (ticker: COLL) is developing the asset, which has been studied in two completed clinical trials, including a Phase 3 efficacy and safety trial in children with ADHD.
HLD200 is being developed for the treatment of Attention Deficit Hyperactivity Disorder. Its clinical program has focused on children and adolescents with ADHD, with trials enrolling participants aged 6 years and older. The studies evaluated efficacy, safety, and pharmacokinetics of the investigational therapy in this patient population.
HLD200 is being developed by Collegium Pharmaceutical, Inc., which trades under the ticker COLL. The company is the sponsor of the clinical program evaluating HLD200 for Attention Deficit Hyperactivity Disorder, including a Phase 3 trial and a Phase 1 pharmacokinetic study conducted in the United States.
HLD200 is in Phase 3 development for Attention Deficit Hyperactivity Disorder. It is an investigational therapy and has not been approved by the FDA. Two trials have been completed: a Phase 3 efficacy and safety study and a Phase 1 pharmacokinetic study, with no trials currently active.
HLD200 has been evaluated in two completed clinical trials. NCT02255513 was a Phase 3 trial assessing efficacy and safety in children with ADHD, enrolling 43 participants. NCT01907360 was a Phase 1 pharmacokinetic study in children and adolescents with ADHD, enrolling 29 participants. Both were conducted in the United States.
HLD200 is also known as HLD200 (methylphenidate hydrochloride). Methylphenidate hydrochloride is the active ingredient in this investigational formulation. Readers searching for either name are referring to the same asset being developed by Collegium Pharmaceutical, Inc. for Attention Deficit Hyperactivity Disorder.