PBA episode reduction in patients with these neurologic conditions who took NUEDEXTA1,2

In the open-label PRISM II trial (N=367), the primary endpoint was change from baseline to Day 90 in CNS-LS score

  • CNS-LS score in all cohorts combined was 20.4 at baseline to 12.8 at Day 90 (P<0.001 vs baseline)
  • CNS-LS reductions were similar across all 3 disease cohorts (dementia, stroke, and TBI) with a range of 7.2 to 8.5 at Day 90

SECONDARY ENDPOINT: MEDIAN REDUCTION FROM BASELINE IN NUMBER OF PBA EPISODES/WEEKa,1

OPen Label Efficac

 

aMedian episode count is depicted as it is resistant to outliers, unlike the mean.

  • 20.4% (n=75) of participants were aged 75 or older2
  • 82% of patients were living at home2

GLOBAL IMPROVEMENT AND SATISFACTION RATING AT DAY 90 (SECONDARY OUTCOMES)a,2

 
72.4% of patients (based on PGIC) reported Much/Very Much Improved with respect to PBA

PGICc

72.4%

of patients were Much Improved or Very Much Improved with respect to PBAb

76.6% of patients as rated by their clinician (based on CGIC) reported Much/Very Much Improved with respect to PBA

CGICc

76.6%

of patients as rated by their clinician were Much Improved or Very Much Improved with respect to PBAb

75.5% of patientsd reported Somewhat/Very Satisfied with NUEDEXTA

SATISFACTIONd

75.5%

of patients were Somewhat Satisfied or Very Satisfied with NUEDEXTAb

% of patients (n=261)

These scales are subjective measures and may be subject to bias particularly in the context of an open-label study.

aRatings measured at Day 90/Final Visit.2
bCaregivers completed the rating when the patient was not able to do so.2
cUsing the Patient Global Impression of Change (PGIC) and Clinical Global Impression of Change (CGIC) scales, patients/clinicians were asked, “Rate the total impression of change in your/your patient’s condition (with respect to PBA) from the time of study admission to the present (end of study).” PGIC reported: 32.6% Very Much Improved; 39.8% Much Improved; 18.8% Minimally Improved; 8% No Change; 0.4% Minimally Worse; 0.4% Much Worse. CGIC reported: 33.7% Very Much Improved; 42.9% Much Improved; 13.4% Minimally Improved; 8.8% No Change; 0.8% Minimally Worse; 0.4% Much Worse. No patients/clinicians reported Very Much Worse.2
dPatients/caregivers were asked, “How satisfied are you with NUEDEXTA as a treatment for your PBA?” Reported: 47.5% Very Satisfied; 28% Somewhat Satisfied; 11.5% Neither Satisfied nor Dissatisfied; 5.4% Somewhat Dissatisfied; 7.7% Very Dissatisfied.2

 

Study Description
 

PRISM ll, 90-day, open-label (uncontrolled), 74-site US trial in adult patients with dementia, stroke, or TBI. All patients had a clinical diagnosis of PBA and a CNS-LS score ≥13 at baseline. Patients received 1 capsule of NUEDEXTA QD during Week 1 and were titrated to 1 capsule Q12H for Weeks 2 through 12. The primary endpoint was change from baseline in CNS-LS score. Effectiveness population: Dementia: Baseline n=108, Day 30 n=108, Day 90 n=102. Stroke: Baseline n=103, Day 30 n=103, Day 90 n=92. TBI: Baseline n=87, Day 30 n=86, Day 90 n=67. Overall: Baseline n=298, Day 30 n=297, Day 90 n=261.1,2