Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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...