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
Intervention: Vyvanse (lisdexamfetamine dimesylate), NRP104
Intervention description: 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
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 349.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Attention Deficit Hyperactivity Disorder; Attention Deficit Disorders with Hyperactivity; Attention Deficit Hyperactivity Disorders

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject must be 18-55 years of age, inclusive, at the time of consent of the
             NRP104.303 study.

          -  Subject must have been randomized and must have met all inclusion/exclusion criteria
             in the NRP104.303 study.

          -  Subject must be male or non-pregnant female. Females of childbearing potential (FOCP)
             must comply with contraceptive restrictions noted in the protocol.

          -  Subject must have a satisfactory medical assessment with no clinically significant or
             relevant abnormalities as determined by medical history, PE, clinical and laboratory
             evaluation.

          -  In the opinion of the investigator, the subject understands and is able, willing, and
             likely to fully comply with the study procedures and restrictions.

          -  Subject must have given written, personally signed and dated informed consent to
             participate in the study in accordance with the International Conference on
             Harmonization (ICH) Good Clinical Practice (GCP) Guidelines and applicable regulations
             before completing any study specific procedures.

          -  Subject experienced no adverse events in a previous study of NRP104 or elsewhere that
             would preclude continued exposure to NRP104.

        Exclusion Criteria:

          -  Subject has any concurrent chronic or acute illness or unstable medical condition that
             could confound the results of safety assessments, increase risk to the subject or lead
             to difficulty complying with the protocol. Subjects who have a history of mental
             retardation or a severe learning disability are excluded.

          -  Subject has a known cardiac structural abnormality or any other condition that may
             affect cardiac performance.

          -  Subject has any clinically significant ECG or laboratory abnormality known to the
             investigator prior to dispensation of study medication.

          -  Subject has a resting sitting systolic blood pressure or diastolic blood pressure
             deemed clinically significant by the investigator.

          -  Subject has used any prohibited prescription medication except for medications used to
             treat ADHD within 30 days of screening visit. Hormonal contraceptives are acceptable.

          -  Subject has a positive urine drug result at Screening (with the exception of subject's
             current stimulant therapy, if any).

          -  Subject has taken an investigational drug or taken part in a clinical trial within 30
             days prior to Screening (except for participating in an NRP104 study).

          -  The female subject is pregnant or lactating.