A Safety and Effectiveness Study of Methylphenidate HCl Extended-release Tablets in Adults With Attention Deficit Hyperactivity Disorder
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the effectiveness and safety of methylphenidate HCl
      extended-release tablets at five dose levels compared to placebo in adults with Attention
      Deficit Hyperactivity Disorder (ADHD)
    

Detailed description: 
      This is a randomized (patients are assigned different treatments based on chance),
      placebo-controlled , double-blind (neither the patient nor the physician knows whether drug
      or placebo is being taken), parallel-group, dose-titration, multicenter study to determine
      the effectiveness and safety of five doses of methylphenidate HCl extended-release tablets,
      36 mg, 54 mg, 72 mg (two 36 mg tablets), 90 mg (one 36 mg tablet plus one 54 mg tablet), or
      108 mg (two 54 mg tablets) administered orally once per day in adults with Attention Deficit
      Hyperactivity Disorder. Patients will be randomized to receive either placebo or
      methylphenidate HCl extended-release tablets for seven weeks. Patients assigned to
      methylphenidate HCl extended-release tablets will start treatment with 36 mg and continue to
      receive incremental increases of 18 mg of methylphenidate HCl extended-release tablets every
      seven days (+/-2 days) until an individualized dose is achieved. The individualized dose is
      achieved when Adult ADHD Investigator Symptom Rating Scale (AISRS) decreases by 30% and a
      Clinical Global Impression - Improvement (CGI-I) score is 1 or 2, or titration to the maximum
      dose of 108 mg is achieved. If a limiting adverse event occurs, the dose will be titrated
      downward by 18 mg. This dose is then the patient's individualized dose. Once an
      individualized dose has been achieved, patients will remain on that dose for the duration of
      the titration period and for the two weeks prior to Final Visit/2-Week Efficacy Assessment
      Visit. Patients assigned to placebo will follow the same dosing schedule and procedures as
      the patients randomized to methylphenidate HCl tablets. Safety assessments include monitoring
      adverse events, blood pressure, pulse, weight, and electrocardiograms (ECG) throughout the
      study. The primary hypothesis is that methylphenidate HCL extended-release tablets at an
      individualized dose will be superior to placebo with respect to improvement in the primary
      efficacy endpoint defined by change from baseline in the Adult ADHD Investigator Symptom
      Rating Scale. Patients will initiate methylphenidate HCl extended-release tablets with 36 mg
      and continue to receive increases in 18 mg increments for 7 days until an individualized dose
      or maximum dose of 108 mg is achieved. Patients will remain on this dose for the duration of
      the titration period and for 2 weeks prior to Final Visit/2 Week Efficacy Assessment; a
      maximum of 51 days. Patients receiving placebo will follow the same dosing
      schedule/procedures as patients receiving methylphenidate HCL tablets
    

Intervention name(s): methylphenidate hydrochloride extended-release tablets
Intervention type(s): Drug
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Attention Deficit Disorder with Hyperactivity, ADHD, Attention Deficit Disorder Adult