Status EpilepticusNCT01268904
Safety and Efficacy of Intravenous Valproate in Pediatric Status Epilepticus and Acute Repetitive Seizures
An observational study of Status Epilepticus, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
To evaluate the safety and efficacy of intravenous valproate in pediatric status epilepticus and acute repetitive seizures as part of seizure treatment protocol in pediatric ER Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Status Epilepticus
- What is being tested?
- Valproate
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2011to Aug 2013
- Phase
- Observational
- 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 6 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric inpatients and emergency patients
Who may be able to join
- Child with clinical presentation of status epilepticus
Who cannot join
- All others
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the safety and efficacy of intravenous valproate in pediatric status epilepticus and acute repetitive seizures as part of seizure treatment protocol in pediatric ER
- Conditions
- Status Epilepticus
- Being tested
- Valproate
- Medical subject headings
- Status Epilepticus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValproateDrug
Intravenous valproate application to pediatric patients suffering from status epilepticus and acute repetitive seizures
| Study group | Role | What they receive |
|---|---|---|
| Pediatric status epilepticus | Not described Receives: Drug: Valproate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of intravenous valproate in pediatric status epilepticus
Measured: One week
Secondary outcomes (1)
Efficacy of intravenous valproate in pediatric status epilepticus
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2010 (estimated)
- Study startJan 2011
- Primary completionJul 2013 (estimated)
- Study completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01268904
- Sponsor's protocol ID
- 0098-10-HYMC
- Status last verified
- Dec 2010
- First submitted
- 30 Dec 2010
- Last updated
- 31 Dec 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Intravenous Valproate in Pediatric Status Epilepticus and Acute Repetitive Seizures
- ClinicalTrials.gov ID
- NCT01268904
- Acronym / sponsor ID
- 0098-10-HYMC
- Conditions
- Status Epilepticus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Jan 2011
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 31 Dec 2010 (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.
To evaluate the safety and efficacy of intravenous valproate in pediatric status epilepticus and acute repetitive seizures as part of seizure treatment protocol in pediatric ER
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric status epilepticus | – | Drug: Valproate |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric inpatients and emergency patients
Key inclusion criteria (1 listed)
- Child with clinical presentation of status epilepticus
Key exclusion criteria (1 listed)
- All others
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 |
|---|---|---|
| ValproateIntravenous valproate application to pediatric patients suffering from status epilepticus and acute repetitive seizures | Drug | Pediatric status epilepticus |
Primary outcome
Safety of intravenous valproate in pediatric status epilepticus
Time frame: One week
1 secondary outcome
Efficacy of intravenous valproate in pediatric status epilepticus
Time frame: One week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2010.
Related trials for Status Epilepticus
RecruitingPhase 3
A Study to Test the Efficacy and Safety of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures
Stereotypical Prolonged Seizures
Not yet recruitingObservational study
Predictors of Outcomes of Convulsive Status Epilepticus
Status Epilepticus, Convulsive Status Epilepticus
Enrolling by invitationPhase 3
A Study to Test the Safety and Tolerability of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures
Stereotypical Prolonged Seizures
Recruiting
Acute Effects of Focused Ultrasound Modulation on EEG Behavior in Status Epilepticus Patients
Seizures
RecruitingPhase 3
Ketamine add-on Therapy for Established Status Epilepticus Treatment Trial (KESETT)
Status Epilepticus
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Status Epilepticus, run by Hillel Yaffe Medical Center at 1 site in Israel.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 31 Dec 2010. 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 Israel. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Iyad Magadly, MD (972-4-6304331, magadly@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of intravenous valproate in pediatric status epilepticus (time frame: One week). 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 31 Dec 2010.