Clinical trial NCT03025906: Phenobarbital Versus Valproate for Generalized Convulsive Status Epilepticus
Official title: Phenobarbital Versus Valproate for Generalized Convulsive Status Epilepticus in Adults: A Prospective Randomized Controlled Trial in China
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Generalized Convulsive Status Epilepticus
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2017-01-20
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Although generalized convulsive status epilepticus (GCSE) is a life-threatening emergency, evidence-based data to guide initial drug treatment choices are lacking in the Chinese population. The investigators conduct this prospective randomized controlled trial to evaluate the relative efficacy and safety of intravenous (IV) phenobarbital (PB) and valproate (VPA) in patients with GCSE.

Detailed description: After the failure of first-line diazepam treatment, patients with GCSE are randomized to receive either IV PB (standard doses, low rate) or VPA (standard). Successful treatment is considered when clinical and electroencephalographic seizure activity ceases. Adverse events following treatment and the neurological outcomes at discharge and 3 months later are also evaluated.

Eligibility criteria: Inclusion Criteria:

* All consecutive GCSE patients (after the failure of first-line diazepam treatment) who were admitted in the emergency room or neurocritical care unit in Xuanwu Hospital of Capital Medical University.

Exclusion Criteria:

* Unstable vital signs, such as a systolic blood pressure of \<90 mm Hg, a pulse of \<60 beats per min, or an arterial blood oxygen saturation of \<90%,
* Liver dysfunction (alanine transaminase or total bilirubin of more than twice the normal upper limit),
* Neurologic emergency requiring immediate surgical intervention,
* Pregnancy or breast feeding,
* Hypersensitivity to study drugs.

Primary outcomes:
measure: Number of patients with effective seizure control
timeFrame: One hour after the end of the PB or VPA loading dose
Secondary outcomes:
measure: Mortality of patients
timeFrame: at 30 days and at 3 months
measure: Number of patients with post-SE symptomatic epilepsy
timeFrame: 3 months
measure: The relapse rates of SE and nonconvulsive status epilepticus (NCSE) / nonconvulsive seizures (NCS)
timeFrame: in the first 24 h
Other outcomes:
measure: Number of Participants With Adverse Events
timeFrame: From the administration of PB or VPA to 1 week
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital
state: Beijing
city: Xiamen
country: China
facility: Zhongshan Hospital, Xiamen University
state: Fujian
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
state: Guangdong
city: Changsha
country: China
facility: Xiangya Hospital, Central South University
state: Hunan
city: Shanxi
country: China
facility: Xijing Hospital
state: Xi'an
city: Kunming
country: China
facility: The First People's Hospital of Yunnan Province
state: Yunnan
Study officials:
References: