A Pivotal Efficacy Trial to Evaluate HLD200 in Children With ADHD in a Classroom Setting
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      This Phase 3 pivotal efficacy trial will examine the effects of HLD200 (methylphenidate) in
      patients aged 6-12 years with ADHD in a laboratory classroom setting. This study has a 6-week
      open-label treatment optimization period followed by a one week randomized, double-blind,
      placebo-controlled test phase.
    

Detailed description: 
      To address the unmet need for early morning ADHD symptom control, Ironshore has developed a
      novel drug delivery system that incorporates the active MPH ingredient in a delayed
      release/extended release formulation. This formulation provides a controlled, approximately
      8-hour delay in initial drug release, followed by a subsequent controlled rate of drug
      release throughout the day. The goal of this system is to enable nighttime dosing of MPH to
      provide control of ADHD symptoms at the beginning of the next morning and throughout the
      remainder of the day.

      The phase 3 study used an open-label treatment-optimization phase followed by a double-blind,
      placebo-controlled, 1-week, parallel-group treatment phase to assess safety and tolerability,
      as well as the time course of treatment effect, of evening-dosed HLD200 in pediatric subjects
      with a diagnosis of ADHD. At Visit 2, subjects began daily evening (8:00 pm ±30 minutes)
      treatment with 20 or 40 mg HLD200 (based on prior treatment history) for a period of 1 week
      and then had up to 4 additional weekly visits (Visits 3 to 6) for treatment adjustments to
      achieve both a) an optimal daily dose and b) an optimal treatment time prior to beginning the
      Double-blind Placebo-controlled Test Phase.

      During Visits 3, 4, 5, and 6, investigators were permitted to titrate the dose of study drug
      (up or down) in 20 to 40 mg increments until either achieving the "optimal" daily dose or
      reaching a maximum daily dose of 100 mg/day and/or a maximum dose not exceeding 3.7 mg/kg
      (based on Visit 2 [baseline] weight). The final permitted dose level change was at Visit 6,
      after which, that dose was to be continued through Visit 7 to randomization at Visit 8. The
      subject underwent an assessment of study drug tolerability and, if necessary, could have
      his/her dose reduced. In concert with dose strength adjustments, treatment time adjustments
      were permitted during Visits 3, 4, 5, and 6 in increments of ±0.5 to 1.0 hour until an
      "optimal" treatment time was achieved (between 6:30 pm to 9:30 pm; at least 1 hour following
      completion of dinner). The time for changing final dose timing was at Visit 6 and continued
      through Visit 7 to randomization at Visit 8.

      During the 1-week parallel-group phase, at Visit 8 subjects were randomly assigned (1:1
      ratio) in double-blind fashion to either HLD200 or placebo treatments over the next 7
      evenings. The placebo group received matching placebo at their optimal treatment time, while
      the HLD200 group received HLD200 at their optimal daily dose and treatment time.
    

Intervention name(s): HLD200 methylphenidate hydrochloride (MPH) Capsules; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): HLD200 doses: 20, 40, 60, 80 or 100 mg
Other intervention name(s): methylphenidate
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment