Study to Assess the Safety and Efficacy of NRP104 in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Hyperactivity Disorder; Attention Deficit Disorders With Hyperactivity; Attention Deficit Hyperactivity Disorders
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and effectiveness of NRP104 administered
      as a daily morning dose (30, 50, and 70mg/day) compared to placebo in adults (18-55 years of
      age inclusive) diagnosed with moderate to severe Attention Deficit Hyperactivity Disorder
      (ADHD).
    

Detailed description: 
      This study is a randomized, phase III, multi-center, placebo-controlled, parallel-group,
      forced dose titration in which adult subjects (18-55 years of age inclusive) with ADHD will
      be randomized to NRP104 (30, 50, or 70 mg) or placebo for four weeks of double-blind
      evaluation of safety and efficacy.

      The study will have three phases: (1) screening and washout; (2) baseline; and (3) 4-week
      double-blind evaluation of NRP104 and placebo. The double-blind period will include a forced
      dose titration phase followed by a fixed dose phase. Subjects will be required to visit the
      site up to 6 times over a 5-8 week period, or longer in cases requiring a 28-day wash out.

      Screening and Washout: Subjects will be screened to establish eligibility for study
      participation. The Screening Visit (Visit 1) may take place over multiple days if needed to
      accommodate the subject's schedule. Those subjects who meet eligibility requirements will
      undergo medication washout, if applicable. The length of the ADHD medication washout period
      will range from 7-28 days.

      Baseline: Following medication washout, subjects will return to the clinic for reassessment
      of eligibility criteria and establishment of baseline measures. The interval between the
      first day of the Screening Visit (informed consent date) and the Baseline Visit (Visit 2)
      must not exceed 35 days. Eligible subjects with a baseline ADHD-RS score greater than or
      equal to 28 (performed using adult DSM-IV prompts) will be randomized to treatment.

      Double-blind treatment: Eligible subjects will be randomly assigned (in a 2:2:2:1 ratio of
      each of the three active doses vs. placebo) to a daily morning dose of NRP104 or placebo for
      4 weeks. All NRP104 groups will start at a dose of 30 mg/day. Subjects randomized to 70 mg
      will be titrated to that dose over a 2-week period; those randomized to 50 mg will be
      titrated to that dose over a 1-week period; and those randomized to 30 mg will begin dosing
      on 30 mg per day during week one and will remain on that dose throughout the study.
      Double-blind assessment of the safety and efficacy of NRP104 will proceed for 4 weeks with
      weekly clinic visits scheduled for evaluations and medication disbursement.

      Follow-up period: Subjects who have completed at least 2 weeks of double-blind participation,
      will have the option to continue participation in an open-label extension study (Protocol
      NRP104.304: one-year safety study). Subjects who are not eligible or who choose not to
      participate in the extension study will continue to be followed for thirty days following
      their last dose of study drug. A telephone contact (or contact in person) will be initiated
      by the research site to collect any new or ongoing SAEs and to follow-up on any unresolved or
      related AEs from the Final Study Visit or Early Termination (ET) Visit (Visit 6). If the
      Principal Investigator determines AEs are not acceptably resolved, appropriate follow-up
      should continue until all safety concerns, in the opinion of the Investigator, are resolved.
    

Intervention name(s): NRP104
Intervention type(s): Drug
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Attention Deficit Hyperactivity Disorder; Attention Deficit Disorders with Hyperactivity; Attention Deficit Hyperactivity Disorders