Clinical Trial Search

Primary: Number of Participants With Freedom From Treatment Failure at 16-20 Weeks of Double Blind Therapy — 81; 43; 85 Participants — p=<0.001

Primary: Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) — 42.2; 55.0 percentage of participants

Primary: Anti-seizure Medication Adherence Rate — 68.93; 77.23 score on a scale

Primary: Number of Participants Who Were Seizure Free as Confirmed by Hyperventilation (HV)-Electroencephalography (EEG) at the End of the Maintenance Phase (MP) — 7 Participants

Primary: Change From Baseline to End of Treatment in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) — 3.50 msec

Primary: Change From Baseline in Power of Attention Score to the End of the Double Blind (DB) Period — 111.085; 59.122 Milli seconds (ms) — p=0.700

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: Interictal Epileptiform Discharge (IED) Frequency — 0; 0; 0; 0 IEDs per 5 minutes — p=0.04

Primary: Change From Baseline in Seizure Frequency — 62.0; 36.6 seizures/month — p=0.2490

Primary: Number of Seizure After Treatment by tDCS — 80.67; 93.43; 35.53; 93.14 seizures — p=<0.05

Primary: Percentage Seizure-free for 6 Months, or Longer, Measured at 24 Months After Enrollment — 371; 299 Participants — p=0.11

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

Primary: Cumulative 112-day Exit Rate as Estimated by Kaplan-Meier Method — 0.444; 0.287 proportion of participants

Primary: Proportion of Patients Who Experience the First Unprovoked Seizures (US) Within the First 6 Months After Randomisation (Failure Rate) — 2; 7; 3; 0 Participants

Primary: Mean Weekly Log-transformed Seizure Frequency During Weeks 1 Through 10 — 5.20; 10.77 log[seizures per week]

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

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: Cumulative 112-day Exit Rate as Estimated by Kaplan-Meier Method — 0.156; 0.128 proportion of participants

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

Primary: Percent Change in Partial Seizure Frequency Per Week From Baseline to Visit 6 — 24.24 percent change

Primary: Freedom From Seizure — 7 individuals

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: Change in Partial Onset Seizure (POS) Frequency Per 28 Days From Baseline to the Maintenance Period — -1.55; -3.05 Seizures per 28 days — p==0.0003

Primary: The Standardized Photosensitivity Range (SPR) in the Subject's Most Sensitive Eye Condition — 0.57; 1.38; 1.58; 6.80 Units on a scale

Primary: Percentage of Participants With a Decrease From Baseline in 28-day Seizure Frequency of =50%(Responder) in the Maintenance Period(LOCF) — 31; 50 Percentage of Participants

Primary: Seizure Frequency — 7.3; 5.7; 5.5 ln (Seizures) per 4 weeks

Primary: Percentage of Participants With Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) for Total Group of Participants - Core Phase…

Primary: Treatment Emergent Non-Serious Adverse Events With Greater Than 5% Frequency — 6; 9; 4; 3 Participants

Primary: Electronically Monitored Adherence — 45.5; 50.5 units on a scale — p=0.002

Primary: Sleep Latency Wakefulness After Sleep Onset (WASO) — 42.3; 57.3 minutes/night