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Also known as HLD200 methylphenidate hydrochloride (MPH) Capsules
HLD200 methylphenidate · 2 trials · 1 indication
The ADHD-RS-IV was developed to measure the behaviors of children with ADHD (DuPaul et al., 1998). The scale consists of 18 items designed to reflect current symptomatology of ADHD. Each item is scored in a range from 0 (reflecting no symptoms or a frequency of never or rarely) to 3 (reflecting severe symptoms or a frequency of almost always), with a range of total scores ranging from 0 to 54. In this study, a site clinican (required to be an MD, PhD, DO, licensed social worker, or any trained mental health professional approved by the sponsor) completed ADHD-RS-IV assessments at each visit using a structured interview format.
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 9 sessions occuring at 8:00 am, 9:00 am, 10:00 am, 12:00 pm, 2:00 pm, 4:00 pm, 6:00 pm, 7:00 pm, and 8:00 pm of the laboratory classroom day. Successful training of qualified individuals on the SKAMP scale was required before raters were allowed to perform study assessments.
| Arm | Type | Description |
|---|---|---|
| HLD200 (methylphenidate) | EXPERIMENTAL | Experimental: HLD200 (methylphenidate) The investigational drug for this study is HLD200 MPH MR capsules comprised of the active pharmaceutical ingredient (MPH) in a dual-coated drug-layered core. Following a minimum 72-hour washout, subjects will be randomized (1:1) to double-blind HLD200 to be taken once daily during the evening for a period of 3-weeks prior to testing. |
| Placebo | PLACEBO_COMPARATOR | Placebo capsules will be composed of microcrystalline cellulose beads in place of MPH containing beads found in the HLD200 capsules. Following a minimum 72-hour washout, subjects will be randomized (1:1) to double-blind placebo to be taken once daily during the evening for a period of 3-weeks prior to testing. |
| Name | Type | Description |
|---|---|---|
| HLD200 methylphenidate hydrochloride (MPH) Capsules | DRUG | HLD200 Doses: 40, 60 or 80 mg |
| Placebo | DRUG | - |
Inclusion Criteria: 1. Subjects must be male or female children (6 to 12 years at the time of consent). 2. Subjects must have a diagnosis of ADHD as defined by DSM5 criteria and confirmation using the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID). 3. Subjects...
HLD200 methylphenidate is an investigational small molecule being developed for Attention Deficit Hyperactivity Disorder. It is a Phase 3 candidate from Collegium Pharmaceutical, Inc. (ticker COLL). The program has completed two randomized, double-blind, placebo-controlled Phase 3 trials in children with ADHD, enrolling 288 participants in total across United States sites.
HLD200 methylphenidate is being developed for the treatment of Attention Deficit Hyperactivity Disorder, a psychiatric condition. Both completed Phase 3 trials enrolled children with ADHD, with a minimum age of 6 years, and evaluated the drug in naturalistic and classroom settings. It is investigational and has not been approved for marketing.
Collegium Pharmaceutical, Inc., which trades under the ticker COLL, is the developer of HLD200 methylphenidate. The company is running the clinical program for the ADHD candidate, including the two completed Phase 3 trials conducted in the United States.
HLD200 methylphenidate is in Phase 3 development. Two Phase 3 trials have been completed: NCT02520388, which enrolled 163 children with ADHD in a naturalistic setting, and NCT02493777, which enrolled 125 children in a classroom setting. No trials are currently listed as active. The drug remains investigational.
Two completed Phase 3 trials have evaluated HLD200 methylphenidate in children with ADHD. NCT02520388 was a pivotal efficacy trial in a naturalistic setting that enrolled 163 participants, and NCT02493777 was a pivotal efficacy trial in a classroom setting that enrolled 125 participants. Both were randomized, double-blind, and placebo-controlled, and both were conducted in the United States.
Yes. HLD200 methylphenidate is also known as HLD200 methylphenidate hydrochloride (MPH) Capsules. The two names refer to the same investigational ADHD candidate developed by Collegium Pharmaceutical, Inc. under the ticker COLL.