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Attention deficit hyperactivity disorder (ADHD), is a psychiatric disorder of the neurodevelopmental type in which there are significant problems of attention, hyperactivity, or acting impulsively that are not appropriate for a person's age.
SUMMARY OF THE DATA WITH ELTOPRAZINE:
The data produced demonstrated that at both 5mg and 10 mg, the study met its Primary endpoint as measured by change from baseline in ADHD-RS-IV score in 5mg (p=0.003) and 10mg (p=0.037) doses which were statistically significantly superior to placebo with approximately 25% greater efficacy compared to placebo. Total ADHD-RS-IV scores improved by 13.6, 17.9 and 17.4 points from baseline for placebo, 5mg and 10mg of Eltoprazine, respectively. Inattention, Hyperactivity, and Impulsivity ADHD-RS-IV subscales were also analyzed.
For the Inattention subscale, both 5mg and 10mg groups showed a statistically significant benefit over placebo (0.003 and 0.039, respectively).
For the Hyperactivity subscale, the 5mg dose showed a statistically significant benefit in favor of Eltorprazine treatment compared to placebo (p=0.008); the 10mg dose was superior to placebo, however the difference was not statistically significant (p=0.130).
For the Impulsivity subscale, no significant benefit was observed for either drug dose compared to placebo.
Both 5mg and 10mg demonstrated significantly greater improvement over placebo for CGI-I scores (p=0.023 and 0.004, respectively).
The percentage of subjects who were considered improved by the investigator was 57.9% for placebo, 68.4% for 5mg, and 81.1% for 10mg. The percentage difference was significant between 10mg and placebo (0.029), but it was not between 5mg and placebo (p=0.342).
The results indicate the overall positive outcomes reported on the ADHD-RS-IV were largely driven by the Inattention and Hyperactivity subscales. This phenomenon was expected because most enrolled subjects had primary deficit in Inattention at baseline. Significant benefits of the active treatments were also observed for the following secondary efficacy variables:
Profile of Mood States (POMS):
The 5mg dose was statistically significantly better than placebo for POMS total score (p=0.006)
Both the 5mg and 10mg groups were statistically significantly better than placebo for anger-hostility score (p<0.001 and p=0.036, respectively)
The 5mg group was also statistically significantly better than placebo for tension anxiety score (p=0.046)
Barnes Akathisia Scale (BAS)
Both 5mg and 10mg groups showed a reduction in restlessness and were statistically significantly better than placebo for BAS (p=0.029 and p=0.007, respectively)
Both 5mg and 10mg groups were statistically significantly better than placebo for Awareness of Restlessness subscore (p=0.003 and p<0.001, respectively).
The 10mg group was also statistically significantly better than placebo for Distress Related Restlessness subscore (p=0.047)
Abnormal Involuntary Movement Scale (AIMS)
10mg showed a significantly greater reduction in abnormal movements than placebo (p<0.001)
Attention deficit hyperactivity disorder (ADHD), is a psychiatric disorder of the neurodevelopmental type in which there are significant problems of attention, hyperactivity, or acting impulsively that are not appropriate for a person's age.
SUMMARY OF THE DATA WITH ELTOPRAZINE:
The data produced demonstrated that at both 5mg and 10 mg, the study met its Primary endpoint as measured by change from baseline in ADHD-RS-IV score in 5mg (p=0.003) and 10mg (p=0.037) doses which were statistically significantly superior to placebo with approximately 25% greater efficacy compared to placebo. Total ADHD-RS-IV scores improved by 13.6, 17.9 and 17.4 points from baseline for placebo, 5mg and 10mg of Eltoprazine, respectively. Inattention, Hyperactivity, and Impulsivity ADHD-RS-IV subscales were also analyzed.
For the Inattention subscale, both 5mg and 10mg groups showed a statistically significant benefit over placebo (0.003 and 0.039, respectively).
For the Hyperactivity subscale, the 5mg dose showed a statistically significant benefit in favor of Eltorprazine treatment compared to placebo (p=0.008); the 10mg dose was superior to placebo, however the difference was not statistically significant (p=0.130).
For the Impulsivity subscale, no significant benefit was observed for either drug dose compared to placebo.
Both 5mg and 10mg demonstrated significantly greater improvement over placebo for CGI-I scores (p=0.023 and 0.004, respectively).
The percentage of subjects who were considered improved by the investigator was 57.9% for placebo, 68.4% for 5mg, and 81.1% for 10mg. The percentage difference was significant between 10mg and placebo (0.029), but it was not between 5mg and placebo (p=0.342).
The results indicate the overall positive outcomes reported on the ADHD-RS-IV were largely driven by the Inattention and Hyperactivity subscales. This phenomenon was expected because most enrolled subjects had primary deficit in Inattention at baseline. Significant benefits of the active treatments were also observed for the following secondary efficacy variables:
Profile of Mood States (POMS):
The 5mg dose was statistically significantly better than placebo for POMS total score (p=0.006)
Both the 5mg and 10mg groups were statistically significantly better than placebo for anger-hostility score (p<0.001 and p=0.036, respectively)
The 5mg group was also statistically significantly better than placebo for tension anxiety score (p=0.046)
Barnes Akathisia Scale (BAS)
Both 5mg and 10mg groups showed a reduction in restlessness and were statistically significantly better than placebo for BAS (p=0.029 and p=0.007, respectively)
Both 5mg and 10mg groups were statistically significantly better than placebo for Awareness of Restlessness subscore (p=0.003 and p<0.001, respectively).
The 10mg group was also statistically significantly better than placebo for Distress Related Restlessness subscore (p=0.047)
Abnormal Involuntary Movement Scale (AIMS)
10mg showed a significantly greater reduction in abnormal movements than placebo (p<0.001)
