Clinical Trial Search

Primary: Percentage Change From the Combined Baseline in the Generalized Tonic-clonic Seizure Frequency Per Week Over the 28-week Treatment Period (Dose Adjustment + Evaluation…

Primary: Time to First Seizure — 169; 178 Days

Primary: Median Percent Change in Primary Generalized Tonic Clonic Seizure Frequency (PGTC) Per 28 Days During the Titration and Maintenance Periods (Combined) Relative to…

Primary: Number of Study Participants With Treatment-emergent Adverse Events (TEAEs) Over the Duration of the Treatment Period — 222 Participants

Primary: Incidence of Treatment Emergent Adverse Events During the Entire Study Period — 626 Treatment Emergent Adverse Events

Primary: Percent Change From Baseline in Weekly Primary Generalized Tonic-clonic (PGTC) Seizure Frequency During the Entire Double-Blind Treatment Phase — 32.1; 75.4 percent…

Primary: Log-transformed (Log) 28-day Seizure Rate for All Primary Generalized Tonic-Clonic (PGTC) Seizures During 12-Week Double-Blind Treatment Phase — 1.17; 1.13; 1.14 Seizure…

Primary: Change in the Number of Seizure Days With Absence Seizures From the Baseline Phase to the Maintenance Phase — -0.37 number of seizure days

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

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

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

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: Number of Subjects in the Safety Analysis Set With at Least 1 Treatment-emergent Adverse Event (TEAE) — 84; 14; 10; 1 Participants

Primary: Number of Spikes and Sharp Waves, Relative Change From Baseline to Treatment Day (%). — -7.4; -26.1 percentage of baseline

Primary: Change From Baseline in the Mean Number of Daily Seizures at 1 Year. — 9 Number of Seizures — p=<0.02

Primary: 58-week Retention Rate Measured by the Number of Drop Outs Due to Adverse Events or Seizures From Day 1 of Treatment — 0.61; 0.46; 0.56 proportion of participants…

Primary: 50% Responder Rate — 40.5; 15.6 percentage of participants

Primary: Mean AUC0-last_ss (Test vs. Reference) — 92.884; 62.76666667; 419.97; 260.3 micro/mL/hr

Primary: Average Annualized Costs — 1352; 462; 1357; 1050 United States dollars — p=<0.0001

Primary: Percent Change From Baseline in 28-day Seizure Frequency Through the End of 12-Week Treatment Period — -16.61 Percent change

Primary: Percentage of Participants With SE Cessation Within 30 Minutes of Investigational Product (IP) Initiation Without Medications for the Acute Treatment of SE — 79.59…

Primary: Effectiveness of Medication as Measured by Participation Through the End of the Trial. — 14 participants

Primary: Proportion of Participants Who Achieve Their Assigned Step Goal - Adherence — 0.267 Proportion

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: Number of Participants With Treatment Emergent Adverse Events (AEs), Treatment Emergent Serious Adverse Events (SAEs), Treatment Related AEs and Treatment Related SAEs…

Primary: To Determine if the Frequency of Premenstrual Dysphoric Disorder Differs Among Various Antiepileptic Drug Monotherapies. — 0; 0; 0; 2 Participants

Primary: Number of Subjects With Termination of Seizures at ED Arrival With no Rescue Therapy Given — 329; 282 participants — p=<0.001

Primary: Adherence to Intervention — 2; 0; 0 Participants

Primary: Number of Participants Who Were Seizure Free in the Maintenance Phase (Across Seizure Types and by Seizure Type Within 6 Months Prior to the Start of the Study) — 28…