Clinical Trial Search

Primary: Percent Change From Baseline in Convulsive Seizure Frequency Per 28 Days During the Full Treatment Period — -8.64; -22.16 percent change — p==0.061

Primary: Change in Number of General Tonic-clonic Seizures From Week 8 (Baseline) Visit to Week 12 Visit — 39; 14 General tonic-clonic seizures

Primary: Percentage Change From Baseline In Convulsive Seizure Frequency During The Treatment Period — -38.94; -13.29 percent change — p=0.0123

Primary: Change In Convulsive Seizures During The Treatment Period Compared To Baseline — 48.7; 45.7; 26.9 percentage reduction — p=0.0299

Primary: Number Of Participants Who Experienced Severe Treatment-Emergent Adverse Events (TEAEs) — 2; 1; 0; 1 Participants

Primary: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Occurring in ≥5% of Participants in Any Treatment Group — 306; 353; 135; 140 participants

Primary: Percentage of Participants With Adverse Events — 88.9; 92.3; 88.2; 90.4 Percentage of participants

Primary: Change From Baseline in the Mean Convulsive Seizures Frequency (MCSF) to the Combined Titration and Maintenance Periods (T+M) in Participants Receiving ZX008 0.8…

Primary: Change in Convulsive Seizure Frequency (CSF) From the Baseline Period (Baseline) to the Combined Titration + Maintenance (T+M) Period — -3.18; -0.65 Convulsive seizures…

Primary: Change From Baseline in Median Monthly Convulsive Seizure Frequency — 88.429 Number of monthly seizures

Primary: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) — 75.5 percentage of participants

Primary: Summary of 28-day Seizure Frequency for Major Motor Seizure Types — 49.17; 54.00; 55.50; 45.03 Seizures per day

Primary: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) During the Open-label Extension (OLE) Treatment Period — 98.1 percentage of participants

Primary: Percent Change From Baseline in 28-Day Convulsive Seizure Frequency During Ataluren Treatment Period — 723.17 percent change

Primary: % Change in Frequency of Handwaving Episodes — -66.2 % change in hand waving episodes — p=<0.001

Primary: Reported Change in Seizures Frequency From Baseline at 13 Weeks — 4.4; 189.5 seizures/two weeks

Primary: Maximum Plasma Concentration (Cmax) for Cannabidiol and Metabolite 7-hydroxy (7-OH) Cannabidiol — 59.03; 110.5; 256.9; 28.71 nanograms/milliliter (ng/mL)

Primary: Summary of 28-day Seizure Frequency for Sum of Individual Seizures and Clusters for 52-week OLE Period (Mean Percent Change & Standard Deviation) — -31.23; NA; 122.10…

Primary: Number of Seizures Per Month — 33.5; 30.0; 3.0; 0.5 Seizures per month

Primary: Number of Participants Reporting Improvement on the Clinical Global Impression — 1; 10 Participants

Primary: Percent Change From Baseline in Motor Seizure Frequency Per 28 Days During the Maintenance Period — 11.7; -23.6 percent change

Primary: Safety and Tolerability of NB-001 — 18; 24; 14; 20 Participants

Primary: Non-HDL Cholesterol — 128; 107 mg/dl

Primary: Cognitive Assessment Scores and Developmental Impact — 83.9; 80.9; 97.3; 85.0 score on a scale — p=0.8681

Primary: Number of Participants With Indicated Evaluations That Were Completed or Recommended by the PCP — 69; 79; 36; 31 participants — p=0.018

Primary: Ratio of Spike-Wave Index (SWI) During First Hour of Nonrapid Eye Movement (NREM) Sleep at Week 6 — -0.02; 0.01 Log-transformed ratio — p=0.4326

Primary: Change in Epworth Sleepiness Scale From Baseline to End of Study — -1; -0.5; 1 units on a scale

Primary: Percent Reduction From Baseline to Week 8 in Frequency of Total Seizures (Normalized to a 4-Week Rate) — 12.6; 0.0 percent reduction of seizures per 4 wks — p=0.5812

Primary: List Sorting Working Memory Test — 37.14; 39.14 T-score

Primary: Overall Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (SAEs) — 12; 3 Participants