Study to Evaluate SAGE-547 Injection as Adjunctive Therapy for the Treatment of Super-Refractory Status Epilepticus (SRSE)
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|ClinicalTrials.gov Identifier: NCT02052739|
Recruitment Status : Completed
First Posted : February 3, 2014
Last Update Posted : April 26, 2017
|Condition or disease||Intervention/treatment||Phase|
|Super-refractory Status Epilepticus||Drug: SAGE-547||Phase 1 Phase 2|
This is an open-label study consisting of a Screening period (1 day), 4-day treatment period (96 hours) followed by a 1-day dose taper period (24 hours), a 2-day acute follow-up period, and a 3 week extended follow-up period.
On Day 1 of treatment SRSE subjects under seizure suppression or burst-suppression with a continuous IV AED (third-line agent) will be given a 1-hour IV loading infusion of SAGE-547 followed by a maintenance infusion. After 48 hours of SAGE-547 treatment, the continuous IV AED (third-line agent) will be weaned while continuing SAGE-547 at the maintenance infusion for the remainder of the treatment period. After 96 hours (4 days) of therapy with SAGE-547, the dose will be tapered and discontinued over 24 hours.
The subjects will have routine continuous EEG monitoring during the Screening period, and continuing until 48 hours after SAGE-547 treatment has completed. Subjects will then have follow-up examinations weekly for the next 3 weeks (Days 8, 15, 22, and 29), during which safety and functional assessments will be obtained. Apart from treatment with SAGE-547, all subjects will receive the standard of care for adults in SRSE along with ongoing treatment for all underlying medical conditions.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of SAGE-547 Injection as Adjunctive Therapy for the Treatment of Super-Refractory Status Epilepticus|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
Experimental: active drug
- Safety and tolerability in subjects in super-refractory status epilepticus (SRSE) [ Time Frame: 29 Days ]Safety will be evaluated via clinical laboratory measures, vitals, EEG and ECG throughout the 29 day study period
- Efficacy of SAGE-547 on super-refractory status epilepticus as indicated by the need to re-institute a continuous IV AED (third-line agent), for refractory seizure control as well as the duration of the observed response [ Time Frame: 96 hours ]
- Pharmacokinetics (PK) of SAGE-547 exposure [ Time Frame: 7 Days ]Plasma PK parameters will be calculated where appropriate (eg, Cmax, Cmin, Tmax, AUClast, AUC∞, CLs). It will be collected prior to, during, and after completion of SAGE-547 dosing.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02052739
|Study Chair:||Stephen J Kanes, M.D., Ph.D.||Sage Therapeutics|