CompletedPhase 1/2

Study to Evaluate SAGE-547 Injection as Adjunctive Therapy for the Treatment of Super-Refractory Status Epilepticus

United States25 participantsStarted 2014-03-21

Plain-language summary

The purpose of this study is to evaluate the safety and tolerability of SAGE-547 in participants in super-refractory status epilepticus (SRSE).

Who can participate

Age range2 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Participants 2 years of age and older. * Participants with an EEG-confirmed SRSE diagnosis under concomitant therapy with a continuous IV AED (third-line agent) for ≥ 24 hours. For this study, SRSE is defined by the following criteria and in accordance with those used at major epilepsy treatment centers: * Failure to respond to the administration of at least one first-line agent (e.g., benzodiazepine or other emergent initial AED treatment), according to institution standard of care, and * Failure to respond to at least one second-line agent (e.g., phenytoin, fosphenytoin, valproate, phenobarbital, levetiracetam or other urgent control AED) according to institution standard of care, and * Presence of one or more breakthrough seizures \> 6 hours after initiation of the continuous IV AED/third-line agent (e.g., pentobarbital, midazolam, propofol). Exclusion Criteria: * Participants with SRSE due to anoxic/hypoxic encephalopathy, children (participants aged less than 18 years) with an encephalopathy due to an underlying progressive neurological disorder. * Participants with clinically significant electrocardiogram abnormalities. * Participants with a significant medical or surgical condition that may compromise vital organ systems, or other conditions that would place the participants at increased risk such as dialysis or acute respiratory distress syndrome, severe cardiogenic or vasodilatory shock requiring 2 or more pressors, fulminant hepatic f…

What they're measuring

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

Timeframe: Up to Day 29

Change From Baseline (CFB) in National Institutes of Health Stroke Scale (NIH-SS) Total Score

Timeframe: Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29

Change From Baseline in Vital Sign Parameter: Body Weight

Timeframe: Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29

Change From Baseline in Vital Sign Parameter: Heart Rate

Timeframe: Baseline (Screening) to infusion at 0-24 hours: Loading-predose and at 15,30,45 minutes;1,2,4,8 and 24 hour;25-48: 48 hour;49-72:72 hours;73-96: 96 hour;97-120:120 hours;Acute follow-up at 121-144,145-168 hours; Extended Follow-up at Days 8, 15, 22 and 29

Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP

Timeframe: Baseline (Screening) to infusion at 0-24 hours:Loading-predose and at 15,30,45 minutes;1,2,4,8 and 24 hour;25-48: 48 hour;49-72: 72 hour;73-96: 96 hour;97-120:120 hour;Acute follow-up at 121-144,145-168 hours;Extended follow-up at Days 8,15,22 and 29

Change From Baseline in Vital Sign Parameter: Respiratory Rate

Timeframe: Baseline (Screening) to infusion at 0-24 hours:Loading-predose and at 15,30,45 minutes;1,2,4,8 and 24 hour;25-48: 48 hour;49-72:72 hours;73-96: 96 hour;97-120:120 hours;Acute follow-up at 121-144,145-168 hours;Extended follow-up at Days 8, 15, 22 and 29

Trial details

NCT IDNCT02052739

SponsorSupernus Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-05-03

Results submitted2022-02-16

View on ClinicalTrials.gov More Super-refractory Status Epilepticus trials

Who can participate

Age range2 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

Timeframe: Up to Day 29

Change From Baseline (CFB) in National Institutes of Health Stroke Scale (NIH-SS) Total Score

Timeframe: Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29

Change From Baseline in Vital Sign Parameter: Body Weight

Timeframe: Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29

Change From Baseline in Vital Sign Parameter: Heart Rate

Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP

Change From Baseline in Vital Sign Parameter: Respiratory Rate

Timeframe: Baseline (Screening) to infusion at 0-24 hours:Loading-predose and at 15,30,45 minutes;1,2,4,8 and 24 hour;25-48: 48 hour;49-72:72 hours;73-96: 96 hour;97-120:120 hours;Acute follow-up at 121-144,145-168 hours;Extended follow-up at Days 8, 15, 22 and 29