Grand Mal Status EpilepticusPhase 3NCT01586208
Refractory Status Epilepticus Treatment Study
A Phase 3 study testing valproic acid (VPA) in people with Grand Mal Status Epilepticus and Non-convulsive Status Epilepticus, run by Hospital Universitari de Bellvitge at 1 site in Spain.
Trial summary
Identify the most effective dose of valproic acid when used in combination with phenytoin for treatment of patients with refractory status epilepticus, which allow a better clinical course and prognosis of the disease. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Grand Mal Status Epilepticus, Non-convulsive Status Epilepticus
- What is being tested?
- valproic acid (VPA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2010to Oct 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients ≥ 18 years of age who meet the diagnosis of EER seizure, and previously they have been treated according to the clinical protocol at our center status (Diazepam 10mg Clonazepam 1mg and Phenytoin or iv at a dose of 20mg/kg in case persistence of the clinic):
- -Present seizures for at least 30 minutes without regaining awareness among them.
- Patients ≥ 18 years of age who meet the diagnosis of nonconvulsive EER, and previously they have been treated according to the clinical protocol at our center status (Diazepam 10mg Clonazepam 1mg and Phenytoin or iv at a dose of 20mg/kg in case persistence of the clinic):
- After submitting an EER seizures that yield clinically performed an EEG that shows SE electricity.
- Evidence of a non-convulsive SE to perform an EEG of a patient admitted for any cause, either by filing seizures, altered mental status, or any other cause, and to persist after the treatment administered previously discussed.
- Patients in whom it has obtained the written informed consent by the representative and/or patient, as the case
Who cannot join
- Patients with severe cerebral anoxia, when the first EEG evidences a pattern of flare-suppression.
- Patients who registers PLEDs (periodic epileptic lateralaized Discharges) without clinical seizure activity association to register or without electrical crises.
- Patients < 18 years of age.
- Patients in whom there is diagnostic doubt (eg non-convulsive status among and encephalopathy).
- Pregnant or breastfeeding.
- Patients with allergy to phenytoin, hydantoin or hypersensitivity to sodium valproate
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- Patients with porphyria
- Patients with severe liver disease or dysfunction.
- Patients with heart block or second and third grade sinus bradycardia.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
About this study
Official title: Refractory Status Epilepticus: Plasmatic Levels Monitorization Utility
Identify the most effective dose of valproic acid when used in combination with phenytoin for treatment of patients with refractory status epilepticus, which allow a better clinical course and prognosis of the disease.
Read the detailed description
Phase III Clinical trial, to identify the most effective dose of valproic acid (20mg/kg bolus, 1mg/kg/h maintenance vs 40mg/kg bolus, 2mg/kg/h maintenance) in combination with phenytoin, in patients with refractory status epilepticus.
Multicenter clinical trial, single-blind, prospective, randomized 1:1 assignment.
- Being tested
- valproic acid (VPA)
- Keywords
- refractory status epilepticus, valproic acid, phenytoin, benzodiazepines, Valproic acid initial dosage in status treatment
- Medical subject headings
- Status Epilepticus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
valproic acid (VPA)Drug
Also called Valrpoic acid, Phenytoin, Benzodiazepines, Status Epilepticus Refractarius
Best dosage at the initial bolus of VPA in patient with satatus epilepticus refractarius (after benzodiazepine + phenytoin treatment)
| Study group | Role | What they receive |
|---|---|---|
| 40mg/kg intial valproate bolus | Active comparator | Patient receives a 40mg/kg valproate bolus with a maintenance of 1mg/kg/h, after benzodiazepine + phenytoin administration Receives: Drug: valproic acid (VPA) |
| 20mg/Kg intial bolus valproate | Active comparator | Patient receives a 20mg/kg valproate bolus with a maintenance of 1mg/kg/h, after benzodiazepine + phenytoin administration Receives: Drug: valproic acid (VPA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
status epilepticus resolution
After 48h treatment administration the status epilepticus has to be solved without any other antiepileptic medications
Measured: after 48h treatment administration
Secondary outcomes (1)
Estimation of pharmacokinetic parameters of valproate (VPA) and phenytoin (PHT)
Estimation of pharmacokinetic parameters of VPA (Cl: clearance, Vd: volume of distribution) and PHT (Vmax: maximum speed of metabolism and Km: plasma concentration at which the rate of metabolism is half the maximum)
Measured: During 48h post valproate administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2012 (estimated)
- Study startJan 2010
- Primary completionMay 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Grand Mal Status EpilepticusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari de Bellvitge
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Vall d'Hebron, Germans Trias i Pujol Hospital, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta, Hospital Clinic of Barcelona
- Responsible party
- Principal investigator, Mercè Falip, Hospital Universitari de Bellvitge
- Investigators
- Mercè Falip, MD, Principal investigator, Hospital Universitari de Bellvitge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01586208
- Sponsor's protocol ID
- NEU-2009-01
- Status last verified
- Mar 2013
- First submitted
- 24 Apr 2012
- Last updated
- 12 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Refractory Status Epilepticus: Plasmatic Levels Monitorization Utility
- ClinicalTrials.gov ID
- NCT01586208
- Acronym / sponsor ID
- NEU-2009-01
- Keywords
- refractory status epilepticus, valproic acid, phenytoin, benzodiazepines, Valproic acid initial dosage in status treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Hospital Universitari de BellvitgeUniversity, hospital or other
- Collaborators
- Hospital Vall d'Hebron, Germans Trias i Pujol Hospital, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta, Hospital Clinic of Barcelona
- Study start
- Jan 2010
- Primary completion
- May 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 26 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Identify the most effective dose of valproic acid when used in combination with phenytoin for treatment of patients with refractory status epilepticus, which allow a better clinical course and prognosis of the disease.
Detailed description
Phase III Clinical trial, to identify the most effective dose of valproic acid (20mg/kg bolus, 1mg/kg/h maintenance vs 40mg/kg bolus, 2mg/kg/h maintenance) in combination with phenytoin, in patients with refractory status epilepticus.
Multicenter clinical trial, single-blind, prospective, randomized 1:1 assignment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 40mg/kg intial valproate bolus | Active comparator | Drug: valproic acid (VPA)Patient receives a 40mg/kg valproate bolus with a maintenance of 1mg/kg/h, after benzodiazepine + phenytoin administration |
| 20mg/Kg intial bolus valproate | Active comparator | Drug: valproic acid (VPA)Patient receives a 20mg/kg valproate bolus with a maintenance of 1mg/kg/h, after benzodiazepine + phenytoin administration |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients ≥ 18 years of age who meet the diagnosis of EER seizure, and previously they have been treated according to the clinical protocol at our center status (Diazepam 10mg Clonazepam 1mg and Phenytoin or iv at a dose of 20mg/kg in case persistence of the clinic):
- -Present seizures for at least 30 minutes without regaining awareness among them.
- Patients ≥ 18 years of age who meet the diagnosis of nonconvulsive EER, and previously they have been treated according to the clinical protocol at our center status (Diazepam 10mg Clonazepam 1mg and Phenytoin or iv at a dose of 20mg/kg in case persistence of the clinic):
- Patients in whom it has obtained the written informed consent by the representative and/or patient, as the case
Key exclusion criteria (9 listed)
- Patients with severe cerebral anoxia, when the first EEG evidences a pattern of flare-suppression.
- Patients who registers PLEDs (periodic epileptic lateralaized Discharges) without clinical seizure activity association to register or without electrical crises.
- Patients < 18 years of age.
- Patients in whom there is diagnostic doubt (eg non-convulsive status among and encephalopathy).
- Pregnant or breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| valproic acid (VPA)Also: Valrpoic acid, Phenytoin, Benzodiazepines, Status Epilepticus RefractariusBest dosage at the initial bolus of VPA in patient with satatus epilepticus refractarius (after benzodiazepine + phenytoin treatment) | Drug | 20mg/Kg intial bolus valproate, 40mg/kg intial valproate bolus |
Primary outcome
status epilepticus resolution
Time frame: after 48h treatment administration
After 48h treatment administration the status epilepticus has to be solved without any other antiepileptic medications
1 secondary outcome
Estimation of pharmacokinetic parameters of valproate (VPA) and phenytoin (PHT)
Time frame: During 48h post valproate administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2013.
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Prehospital Early Administration of Ketamine for Status Epilepticus in Epileptic Kids (PEAK-SEEK)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mercè Falip, MD principal investigator
Hospital Universitari de Bellvitge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing valproic acid (VPA) in people with Grand Mal Status Epilepticus and Non-convulsive Status Epilepticus, run by Hospital Universitari de Bellvitge at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
status epilepticus resolution (time frame: after 48h treatment administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2013.