Phenobarbital Versus Valproate for Generalized Convulsive Status Epilepticus

NCT03025906 | Unknown Phase 2 DMC

• 1 other identifier: WEIBANYIZHENGHAN[2012]649
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 6

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.

Conditions

Generalized Convulsive Status Epilepticus

Outcome Measures

Primary Outcomes (1)

• Number of patients with effective seizure control

  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.

  One hour after the end of the PB or VPA loading dose

Secondary Outcomes (3)

• Mortality of patients

  at 30 days and at 3 months

• Number of patients with post-SE symptomatic epilepsy

  3 months

• The relapse rates of SE and nonconvulsive status epilepticus (NCSE) / nonconvulsive seizures (NCS)

  in the first 24 h

Other Outcomes (1)

• Number of Participants With Adverse Events

  From the administration of PB or VPA to 1 week

Study Arms (2)

Phenobarbital

EXPERIMENTAL

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

Valproate

EXPERIMENTAL

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

Interventions

Phenobarbital DRUG

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.

Also known as: Luminal

Phenobarbital

Valproate DRUG

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.

Also known as: Depakine

Valproate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (6)

Xuanwu Hospital

Beijing, Beijing Municipality, 100053, China

RECRUITING

Zhongshan Hospital, Xiamen University

Xiamen, Fujian, China

RECRUITING

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

RECRUITING

Xiangya Hospital, Central South University

Changsha, Hunan, China

RECRUITING

Xijing Hospital

Shanxi, Xi'an, China

RECRUITING

The First People's Hospital of Yunnan Province

Kunming, Yunnan, China

RECRUITING

MeSH Terms

Conditions

Status Epilepticus

Interventions

Phenobarbital; Valproic Acid

Condition Hierarchy (Ancestors)

Seizures; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Barbiturates; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Central Study Contacts

Su Yingying

CONTACT

15901361953; tangsuyingying@sina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: neurology department

Study Record Dates

• First Submitted: November 15, 2016
• First Posted: January 20, 2017
• Study Start: February 16, 2017
• Primary Completion: October 1, 2019
• Study Completion: December 1, 2019
• Last Updated: July 9, 2019

Record last verified: 2019-07

Locations

CN (6)