An Open-label Study 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 assess the long-term safety and efficacy of three NRP104
      doses of 30 mg, 50 mg, or 70 mg, administered at the same time daily, in the treatment of
      adults with ADHD.
    

Detailed description: 
      This is a multi-center, open-label, and single-arm study to assess the safety of three NRP104
      doses (30 mg, 50 mg, or 70 mg per day) for up to one (1) year in the treatment of adults with
      ADHD. Subjects who were randomized and met all inclusion/exclusion criteria in Protocol
      NRP104.303 are eligible for participation in this protocol. The study will consist of three
      periods: a screening/baseline period, a 4-week dose titration, and a long-term maintenance of
      up to 11 months. There are three possibilities for subjects that rollover from the NRP104.303
      protocol. They are:

      Subjects that rollover at the final visit of the NRP104.303 study (on the same day):

      The screening and baseline procedures from this open label study will coincide with the final
      study visit of Protocol NRP104.303. Subject data from final study visit will be transferred
      and utilized for the open label study. On this same day, the subject will be consented for
      NRP104.304, inclusion/exclusion criteria will be assessed, the subject will be enrolled, and
      study medication will be dispensed.

      Subjects that rollover not on the same day but within seven days of the NRP104.303 study:

      If the subject returns to enroll into the NRP104.304 study within seven days of the final
      NRP104.303 study visit and has not taken any excluded medications for which a washout is
      required, the final study visit procedures and data from the NRP104.303 study will be
      transferred and utilized for the screening and baseline visit procedures of this study, where
      applicable. When the subject returns to the site, they will be consented, inclusion and
      exclusion criteria will be assessed, the subject will be enrolled, and study medication will
      be dispensed.

      Subjects will require a full screening visit if more than 7 days have elapsed since they
      completed the NRP104.303 study:

      After screening results have been received by the site, the site personnel will contact the
      subject via telephone to inform them of continued study eligibility. During this call the
      subject will be instructed to stop all medications for the treatment of ADHD, if any. This
      call starts the washout of all psychoactive medications, which should last 7 (±2) days.
      During the Washout Phone Contact, the visit dates for the Baseline visit (Visit 01) and
      Visits 02 through 05 should be scheduled at 7-day intervals as calculated from Baseline.
      After the washout is complete, subjects will return to the clinic for the baseline visit
      (Visit 01) to have the baseline procedures performed and to receive study medication.

      Dose Titration

      All subjects will initiate treatment at NRP104 30 mg for the 1st week. At the subsequent 4
      weekly visits (Visits 02, 03, 04, and 05), the subject's daily dose of NRP104 may be
      increased or decreased by 20 mg at weekly intervals to achieve the optimal efficacy and
      tolerability, if deemed appropriate by the Investigator. In this study, the maximum daily
      dose of NRP104 that can be received by the subject is 70 mg, and the minimum daily dose of
      NRP104 the subject must take to continue the treatment is 30 mg.

      Monthly Maintenance

      At the end of the initial 4-week dose titration (Visit 05), subjects will enter the long-term
      maintenance of up to 11 months. Monthly visits, starting with Visit 06, will have a window of
      ±4 days. All visits will be scheduled relative to the Baseline Visit date. The last scheduled
      visit of the protocol is Visit 16 at Month 12. During the long-term maintenance, the
      subject's dose may be increased or decreased by 20 mg at any visit, if deemed appropriate by
      the Investigator, to maintain optimal treatment in terms of efficacy and tolerability. All
      reasons for dose changes should be well documented by the investigator during the maintenance
      period. Subjects who cannot maintain the minimum daily dose of NRP 30 mg due to intolerance
      will be withdrawn from the study.

      Safety and Efficacy Assessments

      ADHD Rating Scale (ADHD-RS) performed using adult prompts and Clinical Global Impression
      (CGI) will be assessed by the Investigator. The Pittsburgh Sleep Quality Index (PSQI) will be
      assessed once every three months following baseline.

      Adverse events and concomitant medications will be recorded at each visit starting from the
      baseline visit. Vital signs will be measured at each visit from the screening visit. Physical
      exam and clinical laboratory tests (including pregnancy tests) will be assessed at Screening,
      Visit 10 and the final visit. Weight will be measured at the screening visit, baseline visit,
      and every month thereafter. Height will be measured at the screening visit and final visit.
      ECG parameters will be assessed at the screening visit, baseline visit, and every 3 months
      thereafter.
    

Intervention name(s): Vyvanse (lisdexamfetamine dimesylate), NRP104
Intervention type(s): Drug
Intervention description(s): NRP104 capsule once-a-day orally beginning at 30mg/day and titrated by 20 mg per day at weekly intervals up to a maximum daily dose of 70 mg
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Attention Deficit Hyperactivity Disorder; Attention Deficit Disorders with Hyperactivity; Attention Deficit Hyperactivity Disorders