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Phenobarbital Versus Valproate for Generalized Convulsive Status Epilepticus

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ClinicalTrials.gov Identifier: NCT03025906
Recruitment Status : Recruiting
First Posted : January 20, 2017
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
Yingying Su, Xuanwu Hospital, Beijing

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.

Condition or disease Intervention/treatment Phase
Generalized Convulsive Status Epilepticus Drug: Phenobarbital Drug: Valproate Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Phenobarbital Versus Valproate for Generalized Convulsive Status Epilepticus in Adults: A Prospective Randomized Controlled Trial in China
Actual Study Start Date : February 16, 2017
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
Experimental: Phenobarbital
In the PB group, a loading dose of 20 mg/kg (may give an additional 10 mg/kg) begins at a rate of 50 mg/min followed by IV 100 mg q6 h.
Drug: Phenobarbital
In the PB group, a loading dose of 20 mg/kg (may give an additional 10 mg/kg) begins at a rate of 50 mg/min followed by IV 100 mg q6 h.
Other Name: Luminal

Experimental: Valproate
In the VPA group, a loading dose of 30 mg/kg (may give an additional 15 mg/kg) begins at a rate of 3 mg/kg per min followed by a continuous infusion at a rate of 1-2 mg/kg per hour.
Drug: Valproate
In the VPA group, a loading dose of 30 mg/kg (may give an additional 15 mg/kg) begins at a rate of 3 mg/kg per min followed by a continuous infusion at a rate of 1-2 mg/kg per hour.
Other Name: Depakine




Primary Outcome Measures :
  1. Number of patients with effective seizure control [ Time Frame: One hour after the end of the PB or VPA loading dose ]
    The primary study endpoint is the number of patients with effective seizure control, defined as a cessation of clinical and electroencephalographic seizure activity within 1 h after administration of the phenobarbital or valproate loading dose. Effective control of GCSE is assessed clinically by one certified neurologist and also confirmed with EEG by one certified electroencephalographer.


Secondary Outcome Measures :
  1. Mortality of patients [ Time Frame: at 30 days and at 3 months ]
    Neurologic outcome is assessed both at 30 days and at 3 months by one physician unaware of the therapeutic assignment through a phone interview or scheduled follow-up clinic visit. Mortality of each group is recorded at 30 days and at 3 months, respectively.

  2. Number of patients with post-SE symptomatic epilepsy [ Time Frame: 3 months ]
    Post-SE symptomatic epilepsy at 3 months is analyzed. It is defined as the occurrence of at least 2 unprovoked epileptic seizure occurring not earlier than 4 weeks after termination of SE in those without pre-existing epilepsy.

  3. The relapse rates of SE and nonconvulsive status epilepticus (NCSE) / nonconvulsive seizures (NCS) [ Time Frame: in the first 24 h ]
    The investigators also record the relapse rates of SE and nonconvulsive status epilepticus (NCSE) / nonconvulsive seizures (NCS) in each group in the first 24 h.


Other Outcome Measures:
  1. Number of Participants With Adverse Events [ Time Frame: From the administration of PB or VPA to 1 week ]
    Adverse events are recorded as follows: systolic blood pressure lower than 90 mmHg, pulse lower than 50 beats/ min, arrhythmia (except supraventricular tachycardia), respiratory depression (arterial oxygen saturation below 90%, partial pressure of oxygen below 60 mmHg, or partial pressure of carbon dioxide above 60 mmHg), drug-induced liver disease (alanine aminotransferase or total bilirubin increase of more than twice the upper limit of the normal range), elevation of blood ammonia (more than twice the upper limit of the normal range), gastric motility insufficiency, bone marrow suppression (leukocytopenia, neutrocytopenia, thrombocytopenia or anemia), coagulation disorders, or drug-related sedation. The time to record adverse events is from the administration of PB or VPA to 1 week.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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): NCT03025906


Contacts
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Contact: Su Yingying 15901361953 tangsuyingying@sina.com

Locations
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China, Beijing
Xuanwu Hospital Recruiting
Beijing, Beijing, China, 100053
Contact: Su Yingying    15901361953    tangsuyingying@sina.com   
China, Fujian
Zhongshan Hospital, Xiamen University Recruiting
Xiamen, Fujian, China
Contact: Zhuang Xiaorong       zxr63@126.com   
China, Guangdong
Nanfang Hospital, Southern Medical University Recruiting
Guangzhou, Guangdong, China
Contact: Pan Suyue       pansuyue82@qq.com   
China, Hunan
Xiangya Hospital, Central South University Recruiting
Changsha, Hunan, China
Contact: Zhang Le       zlzdzlzd@163.com   
China, Xi'an
Xijing Hospital Recruiting
Shanxi, Xi'an, China
Contact: Jiang Wen       drjiangwen@hotmail.com   
China, Yunnan
The First People's Hospital of Yunnan Province Recruiting
Kunming, Yunnan, China
Contact: Ding Li       dingli701@sina.com   
Sponsors and Collaborators
Xuanwu Hospital, Beijing

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Responsible Party: Yingying Su, neurology department, Xuanwu Hospital, Beijing
ClinicalTrials.gov Identifier: NCT03025906    
Other Study ID Numbers: WEIBANYIZHENGHAN[2012]649
First Posted: January 20, 2017    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Status Epilepticus
Seizures
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Valproic Acid
Phenobarbital
Anticonvulsants
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Hypnotics and Sedatives
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
GABA Modulators
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP3A Inducers