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Efficacy Study of Intravenous Sodium Valproate in Addition to First Line Anti Epileptic Treatment of Generalized Convulsive Status Epilepticus.

Information source: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Generalized Convulsive Status Epilepticus; Intensive Care Unit

Intervention: Intravenous Sodium Valproate (Drug); Placebo (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Assistance Publique - Hôpitaux de Paris

Official(s) and/or principal investigator(s):
Hervé OUTIN, MD, Principal Investigator, Affiliation: Service de Réanimation Médico Chirurgicale, Hôpital Poissy Saint-Germain en Laye

Overall contact:
Hervé OUTIN, MD, Phone: +33 (1) 39 27 52 65, Email: outin@chi-poissy-st-germain.fr


Study Hypothesis Generalized Convulsive Status Epilepticus (GCSE) is a medical emergency associated with an increased morbidity and a prolonged length of hospital stay. Only 50% of patients are discharged from the hospital within the first month after GCSE. Recent Guidelines from Experts highlight the necessity to improve the efficiency of the first line anti-epileptic (AE) therapy. Intravenous Sodium Valproate (SV) might be an adjuvant AE drug to the recommended first line AEs. Intravenous SV is available, well tolerated and easily injectible but also has pharmacologic properties for reducing the risk of seizures relapses and for being neuroprotective. However, efficacy of intravenous as an adjuvant therapy in GCSE has never been properly assessed. Primary Purpose The primary purpose is to assess if the association of intravenous Sodium Valproate with the recommended treatment for Generalized Convulsive Status Epilepticus increases to 20 % the number of living patients, discharged from the hospital at day 15.

Clinical Details

Official title: Randomized and Multicenter Study Assessing the Efficacy of Intravenous Sodium Valproate in Addition to First Line Anti Epileptic Treatment of Generalized Convulsive Status Epilepticus.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Number of patients in ICU for a GCSE discharged alive from the hospital at Day 15.

Secondary outcome:

Frequency of refractory status epilepticus

Morbidity related to ICU stay

Cognitive dysfunction

Detailed description: Patient admitted Intensive Care Unit (ICU) for a Generalized Convulsive Status Epilepticus (GCSE) will be randomized if they fulfil the inclusion criteria and after the written informed consent is obtained from the patient's next of kin. In clack of closed relatives, patients could be included according to the French Health Code for Case of medical emergency. In this situation, patient's consent should be then obtained as soon as possible According to randomization arm, patients will be treated either by intravenous sodium valproate (30 mg/kg during 15 min then 1 mg/kg/h during 12 h) or intravenous placebo. All included patients will benefit from first-line anti epileptic drugs and symptomatic medical care, in agreement with the Experts recommendation (RFE 2009). From day-1 to day-15, level consciousness(Glasgow Coma Scale, Richmond Agitation Sedation Scale), delirium (Confusion Assessment Method For Intensive Care Unit), reoccurrence of seizure, vital signs, organ dysfunction (Simplified Acute Physiology Score II, Sequential Organ Failure) will be daily assessed. At day 2, the preventive oral anti-epileptic drug will be prescribed by a neurologist, blinded from randomization. At Day 15 and Day 30, neurological status, cognitive functions (Mini Mental State Examination, Frontal Assessment Battery, Glasgow Outcome Scale), and quality of life (SF36) will be assessed by a neurologist, also not aware of the randomization. The number of patients alive and discharged from Hospital day 15 15th day will assessed. 300 patients with GCSE will be randomized, 150 in each arm, in 16 ICUs and over a period of 3 years.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Patient older than 18.

- Admitted in a participating ICU for generalized convulsive status epilepticus (GCSE)

i. e. with persistent or repeated generalized seizures without regaining consciousness over a period of five minutes. Generalized convulsive status epilepticus can be controlled or not at time of inclusion.

- Anti convulsant therapy less than 3 hours.

- Written informed consent collected from close relation or a family member of the

patient. Otherwise, inclusion according to French Health Code in case of medical emergency. In this case, the written informed consent of patient has to be collected as soon as possible then. Exclusion Criteria:

- Other type of status epilepticus (including atypical form) occured before the onset

of anti epileptic treatment (However, generalized convulsive status epilepticus preceded by focal or non convulsive seizures can be included)

- The length of stay in hospital expected before the occurrence of GCSE > 15 days

- Expected Length of stay in ICU <12h

- Hypoxic-ischemic encephalopathy

- Pregnant women, eclampsia

- Previous to inclusion, long-term treatment with sodium valproate, divalproate or


- Pre-existing chronic or acute hepatitis

- Liver disease (Transaminase > 3 times standards, Prothrombin rate < 70 % with Factor

V rate < 70 %)

- Family history of acute hepatitis, especially drug-related hepatitis

- Other sodium valproate Contraindications : Hypersensitivity to sodium valproate or

derivatives, hepatic porphyria, mefloquine or hypericum taking

- life expectancy expected ≤ 3 months,

- Patients already already included in another clinical trial on GCSE.

- Non affiliation to a social health care

Locations and Contacts

Hervé OUTIN, MD, Phone: +33 (1) 39 27 52 65, Email: outin@chi-poissy-st-germain.fr

HĂ´pital Raymond Poincare, Garche, Haute de Seine 92380, France; Recruiting
Additional Information

Starting date: February 2013
Last updated: June 23, 2015

Page last updated: August 20, 2015

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