Clinical Trial Search

Primary: 75 % Responder Rate During the 2-week Inpatient Period — 11.1; 30.8 percentage of participants — p==0.0679

Primary: Change in Log-transformed Observable Focal Onset Seizure Frequency From Baseline Over the 12 Week Maintenance Period — -0.27585; -0.46424; -0.48804; -0.48960 loge…

Primary: Percent Change in the 28-day Total Partial Seizure (PS) Frequency From Baseline (BL) to the End of the Double-blind (DB) Phase (Titration and Maintenance Phases)…

Primary: Reduction in Seizure Frequency — 60 percentage

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: Percent Change in the 28-day Total Partial Seizure (PS) Frequency From Baseline (BL) to the End of the Double-blind (DB) Phase (Titration and Maintenance Phases)…

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

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

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

Primary: Percentage of Responders During the Maintenance Phase — 44.4; 34.2; 55.6; 65.8 Percentage of Participants

Primary: Number of Participants With Clinical Cessation of Status Epilepticus - Intention to Treat — 53; 56; 68 Participants

Primary: Double Blind: Cohort 2: Percent Change From Baseline in 28-day Seizure Frequency During Titration + Maintenance Period — -21.28; -10.25 Percent change — p=0.1788

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

Primary: Acute SAE Rate — 12.0 percentage of subjects with ≥ 1 SAE

Primary: Number of Participants Able to be Weaned Off All Third-Line Agents Prior to End of Double-Blind SAGE-547 or Placebo Infusion, and Remain Off All Third-Line Agents for ≥…

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: Number of Participants With a >=50% Reduction in Partial-onset Seizure (POS) Frequency From Baseline — 22; 16; 22; 29 participants

Primary: Time to Next Seizure or Rescue Medication During the Double-blind Period (Kaplan-Meier 50th Percentile) — 5.92; NA Hours — p=0.012

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: Maximum Tolerated Dose (MTD) — 0; 2; 1; 6 Participants

Primary: Number of Participants With Treatment Emergent (TE) Serious Adverse Events (SAEs) and Non-SAEs — 23; 5 Participants

Primary: 50% Responder Rate After Active rTMS Treatment Compared With Placebo Treatment — 0; 0; 0; 0 participants

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

Primary: Percent Change From Baseline in Partial-onset Seizure Frequency Per 28 Days — 55.6; 21.5 percent seizure reduction — p=<0.0001

Primary: Montgomery-Asberg Depression Rating Scale (MADRS) Total Score — -9.0; -6.4 Scores on a scale — p=0.53

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

Primary: The Number of Subjects Completing 24 Weeks Adjunctive Therapy During Maintenance Phase — 36; 37 participants

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

Primary: Study Recruitment Rate — 3.8 participants/3 months