A Pivotal Efficacy Trial to Evaluate HLD200 in Children With ADHD in a Classroom Setting

Women left out

• Age limit under 65

  Older women were turned away, even though they often take this medicine.

  “Maximum age: 12 Years.”

• Had to use birth control

  Women who couldn't or didn't want to use birth control were turned away.

  “A medically highly effective form of birth control must be used during the study and for 90 days thereafter for subjects of either sex of childbearing potential. Examples of medically highly effective forms of birth control are as follows:”

• Weight limit (BMI)

  Women with a higher (or lower) body weight were turned away.

  “Subject is significantly underweight based on Centers for Disease Control and Prevention body mass index (BMI)-for-age sex-specific values at the Screening Visit. Significantly underweight is defined as a BMI \<5th percentile.”

• No seizures

  Women with epilepsy or past seizures were turned away.

  “History of seizure disorder (except febrile seizures prior to age 5 and at least 1 year prior to study participation), Tourette's disorder, or intellectual disability of minor severity or greater (DSM5 criteria).”

• No mental health conditions

  Women with depression, bipolar disorder or other mental health conditions were turned away.

  “History of psychosis, bipolar disorder, anorexia nervosa, bulimia, or suicide attempt. Current depression, anxiety, conduct/behavior disorder, substance use disorder, or other psychiatric condition which, in the investigator's opinion, may…”

• No smokers

  Women who smoke or use nicotine were turned away.

  “Positive screening for illicit drug use or nicotine and/or current health conditions or use of medications that might confound the results of the study or increase risk to the subject.”

Study titles and rules are shown in their original English.