SeizuresNCT03181945
Duration of Anti-convulsant Therapy for Acute Symptomatic Seizure in Acute Encephalitis Syndrome
A study testing Group 4 weeks and Group 12 weeks in people with Seizures, run by Post Graduate Institute of Medical Education and Research, Chandigarh.
Trial summary
There are no guidelines or studies evaluating duration of anti-epileptic drugs in central nervous system infections. The duration of anti-epileptic drug is extrapolated from traumatic brain injury in which duration of 1 weeks to 3 months is suggested. Read more about this study
- Who is it for?
- Ages 3 months to 12 years
- Conditions the study is for
- Seizures
- What is being tested?
- Group 4 weeks and Group 12 weeks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2016to 28 Feb 2019
- Phase
- Interventional
- 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 3 months to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with acute encephalitis syndrome with acute symptomatic seizures on single anti-epileptic drug will be enrolled in Out patient clinic at 4 weeks of illness
Who cannot join
- Children with chronic meningitis, brain abscess, intracranial Space occupying lesion
- Children with prior history of seizures, prior focal neurological deficit
- Children with abnormal development prior to development of seizures
- HIV, Chronic Liver disease, Chronic Kidney disease, acute hepatic encephalopathy
- Children on two or more than 2 anti-epileptic drugs
- Severely affected children (Pediatric Cerebral Performance Category Scale (PCPC) Score, Pediatric Overall Performance Category Scale with category score of 5)
- Refusal of consent
About this study
Official title: Comparison of 4 Weeks Versus 12 Weeks Anti-convulsant Therapy for Acute Symptomatic Seizure in Children With Acute Encephalitis Syndrome- Open Label, Randomized Controlled Trial
There are no guidelines or studies evaluating duration of anti-epileptic drugs in central nervous system infections. The duration of anti-epileptic drug is extrapolated from traumatic brain injury in which duration of 1 weeks to 3 months is suggested. So the investigators plan to conduct this study to decide the optimal duration of anti-epileptic drug in acute symptomatic seizure in central nervous system infections
Read the detailed description
Demography data, seizure details at diagnosis of acute encephalitis syndrome, details of etiology, neuroimaging findings and electroencephalography. A detailed neurological examination will be done in all participants and asked for seizure semiology at admission. Seizure details include seizure type, duration, number of seizures, number of days for which seizures were recurring, status epilepticus, encephalopathy in between seizures. After the initial assessment participants would be randomized into 2 groups: Group 1: Anti-epileptic drug for 4 weeks followed by taper in 10-14days and Group 2: Anti-epileptic drug for 12 weeks followed by tapering over 10-14days. The primary outcome would be be to study the seizure relapse rate (proportion) after stopping anti-epileptic drugs in participants with acute symptomatic seizure given 4weeks and 12 weeks anti-epileptic drug therapy in the two study groups.
Clinical status will be assessed at enrollment as defined by Pediatric Cerebral Performance Category, Pediatric overall Performance Category and Glasgow Outcome Scale-Extended Pediatric Version (GOS-P)
- Conditions
- Seizures
- Being tested
- Group 4 weeks, Group 12 weeks
- Medical subject headings
- Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 4 weeksOther
Anti-epileptic drug (as used by treating physician for management of acute symptomatic seizure) for 4 weeks followed by taper in 10-14days
Group 12 weeksOther
Anti-epileptic drug (as used by treating physician for management of acute symptomatic seizure) for 12 weeks followed by taper in 10-14days
| Study group | Role | What they receive |
|---|---|---|
| Group 4 weeks | Active comparator | Anti-epileptic drug (as used by treating physician for management of acute symptomatic seizure) for 4 weeks followed by taper in 10-14days Receives: Other: Group 4 weeks |
| Group 12 weeks | Active comparator | Anti-epileptic drug (as used by treating physician for management of acute symptomatic seizure) for 12 weeks followed by taper in 10-14days Receives: Other: Group 12 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seizure relapse rate
Seizure relapse rate (proportion of participants) developing seizures after randomization
Measured: 6 months
Secondary outcomes (5)
Correlation of EEG findings at time of stoppage of anti-epileptic drug with seizure recurrence
Correlation of EEG at randomization and seizure recurrence will be done
Measured: 6 months
Factors associated with seizure recurrence
Factors associated with seizure recurrence in the two groups
Measured: 6 months
Seizure relapse rate
Seizure relapse rate (proportion of participants) developing seizures after randomization
Measured: 12 months
Seizure relapse rate
Seizure relapse rate (proportion of participants) developing seizures after randomization
Measured: 18 months
Seizure relapse rate
Seizure relapse rate (proportion of participants) developing seizures after randomization
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2017
- Study start1 May 2016
- Primary completion30 Sep 2018 (estimated)
- Study completion28 Feb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SeizuresStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Whether 4 weeks anti-epileptic drug is as efficacious as 12 weeks anti-epileptic drug therapy for Acute Encephalitis syndrome
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dhawan Sumeet Rajendra, Post Graduate Institute of Medical Education and Research, Chandigarh
- Investigators
- Sumeet Dhawan, MD, Principal investigator, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03181945
- Sponsor's protocol ID
- INT/IEC/2016/114
- Status last verified
- Sep 2018
- First submitted
- 2 Jun 2017
- Last updated
- 28 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dhawan SR, Sahu JK, Singhi P, Sankhyan N, Jayashree M. Comparison of 4 weeks versus 12 weeks antiseizure medication for acute symptomatic seizures in children with Acute Encephalitis Syndrome: An open-label, randomized controlled trial. Seizure. 2021 Nov;92:182-188. doi: 10.1016/j.seizure.2021.09.005. Epub 2021 Sep 10.
PubMed 34543779
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of 4 Weeks Versus 12 Weeks Anti-convulsant Therapy for Acute Symptomatic Seizure in Children With Acute Encephalitis Syndrome- Open Label, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03181945
- Acronym / sponsor ID
- INT/IEC/2016/114
- Conditions
- Seizures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- 30 Sep 2018 (estimated)
- Study completion
- 28 Feb 2019 (estimated)
- First posted
- 9 Jun 2017 (actual)
- 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.
There are no guidelines or studies evaluating duration of anti-epileptic drugs in central nervous system infections. The duration of anti-epileptic drug is extrapolated from traumatic brain injury in which duration of 1 weeks to 3 months is suggested. So the investigators plan to conduct this study to decide the optimal duration of anti-epileptic drug in acute symptomatic seizure in central nervous system infections
Detailed description
Demography data, seizure details at diagnosis of acute encephalitis syndrome, details of etiology, neuroimaging findings and electroencephalography. A detailed neurological examination will be done in all participants and asked for seizure semiology at admission. Seizure details include seizure type, duration, number of seizures, number of days for which seizures were recurring, status epilepticus, encephalopathy in between seizures. After the initial assessment participants would be randomized into 2 groups: Group 1: Anti-epileptic drug for 4 weeks followed by taper in 10-14days and Group 2: Anti-epileptic drug for 12 weeks followed by tapering over 10-14days. The primary outcome would be be to study the seizure relapse rate (proportion) after stopping anti-epileptic drugs in participants with acute symptomatic seizure given 4weeks and 12 weeks anti-epileptic drug therapy in the two study groups.
Clinical status will be assessed at enrollment as defined by Pediatric Cerebral Performance Category, Pediatric overall Performance Category and Glasgow Outcome Scale-Extended Pediatric Version (GOS-P)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Whether 4 weeks anti-epileptic drug is as efficacious as 12 weeks anti-epileptic drug therapy for Acute Encephalitis syndrome
| Arm | Type | Receives |
|---|---|---|
| Group 4 weeks | Active comparator | Other: Group 4 weeksAnti-epileptic drug (as used by treating physician for management of acute symptomatic seizure) for 4 weeks followed by taper in 10-14days |
| Group 12 weeks | Active comparator | Other: Group 12 weeksAnti-epileptic drug (as used by treating physician for management of acute symptomatic seizure) for 12 weeks followed by taper in 10-14days |
Who may qualify
- Ages
- 3 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children with acute encephalitis syndrome with acute symptomatic seizures on single anti-epileptic drug will be enrolled in Out patient clinic at 4 weeks of illness
Key exclusion criteria (7 listed)
- Children with chronic meningitis, brain abscess, intracranial Space occupying lesion
- Children with prior history of seizures, prior focal neurological deficit
- Children with abnormal development prior to development of seizures
- HIV, Chronic Liver disease, Chronic Kidney disease, acute hepatic encephalopathy
- Children on two or more than 2 anti-epileptic drugs
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 |
|---|---|---|
| Group 4 weeksAnti-epileptic drug (as used by treating physician for management of acute symptomatic seizure) for 4 weeks followed by taper in 10-14days | Other | Group 4 weeks |
| Group 12 weeksAnti-epileptic drug (as used by treating physician for management of acute symptomatic seizure) for 12 weeks followed by taper in 10-14days | Other | Group 12 weeks |
Primary outcome
Seizure relapse rate
Time frame: 6 months
Seizure relapse rate (proportion of participants) developing seizures after randomization
5 secondary outcomes
Correlation of EEG findings at time of stoppage of anti-epileptic drug with seizure recurrence
Time frame: 6 months
Factors associated with seizure recurrence
Time frame: 6 months
Seizure relapse rate
Time frame: 12 months
Seizure relapse rate
Time frame: 18 months
Seizure relapse rate
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2018.
- Derived from this study: PubMed 34543779Dhawan SR, Sahu JK, Singhi P, Sankhyan N, Jayashree M. Comparison of 4 weeks versus 12 weeks antiseizure medication for acute symptomatic seizures in children with Acute Encephalitis Syndrome: An open-label, randomized controlled trial. Seizure. 2021 Nov;92:182-188. doi: 10.1016/j.seizure.2021.09.005. Epub 2021 Sep 10.
- Individual participant dataSharing planned: Undecided
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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.
Sumeet Dhawan, MD principal investigator
Post Graduate Institute of Medical Education and Research, Chandigarh
Questions about this trial
What is this clinical trial studying?
A study testing Group 4 weeks and Group 12 weeks in people with Seizures, run by Post Graduate Institute of Medical Education and Research, Chandigarh.
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 7 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 28 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Seizure relapse rate (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03181945, which also lists 1 linked publication.
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 28 Sep 2018.