Last updated on September 2018

Open-label Study to Evaluate Long-term Safety and Efficacy of SPN-812 Extended Release (ER)


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Attention deficit hyperactivity disorder
  • Age: Between 6 - 18 Years
  • Gender: Male or Female

Inclusion Criteria:

  1. Completion of a previous blinded study of SPN-812 ER for the treatment of ADHD.
  2. Continues to be medically healthy and with clinically normal laboratory profiles, vital signs, and electrocardiograms.
  3. Weight of at least 20 kg.
  4. Written Informed Consent obtained from the subject's parent or legally authorized representative; written Informed Assent obtained from the subject if appropriate.

Exclusion Criteria:

  1. Diagnosis of major depressive disorder, bipolar disorder, personality disorder, Tourette's disorder, or psychosis not otherwise specified.
  2. Currently meeting Diagnostic and Statistical Manual of Mental Disorders-5 criteria for an anxiety disorder as primary diagnosis.
  3. Current evidence of suicidality (suicidal thoughts or behaviors).
  4. Body Mass Index greater than 95th percentile for the appropriate age and gender.
  5. Pregnancy, or refusal to practice contraception during the study (for female subjects of childbearing potential).
  6. Current substance or alcohol use.
  7. Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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