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

• Status: Completed
• Trial end date: 2018-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Anticonvulsants; Valproic Acid

Criteria

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. provided that the duration of the treatment prior antiepileptic does not exceed:

• Six hours if GCSE is already controlled at the time of inclusion (= disappearance seizures regardless of the state of consciousness)

• Twenty-four hours if GCSE persisted or is recurrent.

• 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. in absence of a close of patient, the patient may be still included. the consent of the prosecution will be collected

Exclusion Criteria:

• Other type of status epilepticus (including atypical form) occured before the onset of anti epileptic.

• Female patient of childbearing age ≥ 18 ans et < 50 ans

• Patient prior treated by depakine in emergency for the GCSE

• 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 checked by a systematic pregnancy test.

• Pre-existing chronic or acute hepatitis, or Cirrhosis B or C.

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

• Other sodium valproate Contraindications : Hypersensitivity to sodium valproate or derivatives, acute or chronic hepatitis; personal or family history of severe hepatitis, in particular drug; hepatic porphyria, mefloquine or hypericum taking.

• life expectancy expected ≤ 3 months.

• Patients already included in another clinical trial on GCSE.

• Non affiliation to a social health care.

• Patients under tutelage.

• Patient has already been included in this protocol and who completed the clinical trial.