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

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

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: Mean Trough Plasma Concentration at 3rd Level for Age Range ≥1 Month to <2 Years — 0.825 ug/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: Percent Change in Partial Seizure Frequency Per Week From Baseline to Visit 6 — 24.24 percent change

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: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study — 94.4; 93.3; 93.6; 92.3 percentage of participants

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

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

Primary: Sleep Onset Latency — 22.80; 29.99 minutes

Primary: Percentage Change From Baseline in Partial Onset (Type I) Seizure Frequency Per Week Over Time During the Treatment Period — -66.4; -47.8; -66.4 percentage of change

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 in Seizure Frequency — 62.0; 36.6 seizures/month — p=0.2490

Primary: Change From Baseline in Weight Z-score up to Month 1 — -0.112; -0.014 Z-score

Primary: Percentage of Participants Who Were Assessed As Seizure Free — 63.1; 57.6 percentage of participants

Primary: Freedom From Seizure — 7 individuals

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

Primary: Minutes With Seizure on EEG — 165.2; 464.8 minutes with seizure

Primary: Post-operative Seizure-free Rate — 4; 5; 4; 4 Participants

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: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) — 77.2 percentage of participants

Primary: The Percent Change From the Combined Baseline (4-week Retrospective Baseline and 4-week Prospective Baseline) in the Generalized Tonic-clonic Seizure Frequency Per Week…

Primary: Percentage Change (Reduction) of Partial (Type I) Seizure Frequency Per Week From Baseline Over Time During Treatment Period. — 51.06; 68.87 percent reduction in…

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: Area Under the Concentration Time Curve (AUC) 0 to 4 Hours Post-dose — 739.33; 585 hr*ng/mL

Primary: Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (up to 4 Days) — 21 Subjects