Focal EpilepsyNCT05497193
Clinical Efficacy and Safety of Perampanel Monotherapy in the Treatment of Children With Focal Epilepsy
An observational study of Focal Epilepsy, run by Yang Xinwei at 1 site in China.
Trial summary
This project is a multicenter prospective study. By retrieving outpatient medical records and collecting clinical data of epilepsy patients, the efficacy and safety of single-drug perampanel in patients with focal epilepsy were analyzed. Read more about this study
- Who is it for?
- Ages 4 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Focal Epilepsy
- What is being tested?
- perampanel
- How many people
- 280 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2021to 20 Oct 2023
- 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 4 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Patients in the pediatric outpatient department of our hospital
Who may be able to join
- Clinical diagnosis of focal epilepsy; (2) Take anti-epileptic drugs as prescribed by your doctor; (3) Epilepsy patients diagnosed with focal epilepsy with or without generalized seizures, and Monitoring for ≥12 months; (4) Newly diagnosed epilepsy patients, or only taking 1-2 other AEDs, without regular antiepileptic treatment, the efficacy is not good, after using perampanel, gradually stop AEDs for 8 weeks. For perampanel monotherapy; (5) the number of seizures ≥ 1 in the first 3 months of enrollment.
Who cannot join
- syncope (2) Pseudo-seizure(3)transient ischemic attack
Trial locations and contacts
1 site in 1 country.
About this study
This project is a multicenter prospective study. By retrieving outpatient medical records and collecting clinical data of epilepsy patients, the efficacy and safety of single-drug perampanel in patients with focal epilepsy were analyzed.
Read the detailed description
This project is a multicenter prospective study. The selected case population was given the oral antiepileptic drug perampanel for 12 months, and the seizure control (complete control, markedly effective, effective, ineffective, worsening), EEG changes (normal, Effective, ineffective), and adverse reactions were analyzed, so as to provide a basis for perampanel monotherapy in children with focal epilepsy.
- Conditions
- Focal Epilepsy
- Being tested
- perampanel
- Medical subject headings
- Epilepsies, Partial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perampanelDrug
Also called No other interventions currently
China's state food and drug administration approved indications for adults and children aged 4 or more focal epileptic hair company or not with secondary comprehensive seizures of epilepsy, adding treatment, in July 2020 to monotherapy without clinical approval, the current domestic perampanel monotherapy clinical effectiveness and safety of focal epilepsy in children have not been reported.
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical efficacy after drug treatment:
Epilepsy seizures: the seizure frequency 3 months before treatment is the baseline, and the maintenance period is compared with the baseline. Complete control: no seizures after treatment; markedly effective: seizure frequency reduced by > 75%; effective: seizure frequency reduced by > 51%-74 %; Ineffective: frequency reduced by ≤50%, worsening: attack frequency increased by 25%.
Measured: one year
EEG changes after drug treatment
EEG changes: (1) normal EEG (2) abnormal EEG: including epileptiform discharge, background rhythm slowing, epileptiform discharge + background rhythm slowing. EEG judgment: (1) normal: the epileptiform discharge disappeared or the background slowing disappeared (2) effective: the epileptiform discharge was reduced or the background slowing was improved (3) invalid: the epileptiform discharge did not change or aggravate after the drug.
Measured: one year
safety after drug treatment
Common adverse reactions include: dizziness, drowsiness, fatigue, irritability, nausea and falls and weight gain.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start1 Jul 2021
- Primary completion20 Mar 2023 (estimated)
- Study completion20 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focal EpilepsyStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yang Xinwei
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yang Xinwei, Xijing Hospital
- Investigators
- xinwei yang, doctor, Principal investigator, hospital doctor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05497193
- Sponsor's protocol ID
- 20222126
- Status last verified
- Aug 2022
- First submitted
- 26 Jul 2022
- Last updated
- 11 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy and Safety of Perampanel Monotherapy in the Treatment of Children With Focal Epilepsy
- ClinicalTrials.gov ID
- NCT05497193
- Acronym / sponsor ID
- 20222126
- Conditions
- Focal Epilepsy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Yang XinweiUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 20 Mar 2023 (estimated)
- Study completion
- 20 Oct 2023 (estimated)
- First posted
- 11 Aug 2022 (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.
This project is a multicenter prospective study. By retrieving outpatient medical records and collecting clinical data of epilepsy patients, the efficacy and safety of single-drug perampanel in patients with focal epilepsy were analyzed.
Detailed description
This project is a multicenter prospective study. The selected case population was given the oral antiepileptic drug perampanel for 12 months, and the seizure control (complete control, markedly effective, effective, ineffective, worsening), EEG changes (normal, Effective, ineffective), and adverse reactions were analyzed, so as to provide a basis for perampanel monotherapy in children with focal epilepsy.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Patients in the pediatric outpatient department of our hospital
Key inclusion criteria (1 listed)
- Clinical diagnosis of focal epilepsy; (2) Take anti-epileptic drugs as prescribed by your doctor; (3) Epilepsy patients diagnosed with focal epilepsy with or without generalized seizures, and Monitoring for ≥12 months; (4) Newly diagnosed epilepsy patients, or only taking 1-2 other AEDs, without regular antiepileptic treatment, the efficacy is not good, after using perampanel, gradually stop AEDs for 8 weeks. For perampanel monotherapy; (5) the number of seizures ≥ 1 in the first 3 months of enrollment.
Key exclusion criteria (1 listed)
- syncope (2) Pseudo-seizure(3)transient ischemic attack
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 |
|---|---|---|
| perampanelAlso: No other interventions currentlyChina's state food and drug administration approved indications for adults and children aged 4 or more focal epileptic hair company or not with secondary comprehensive seizures of epilepsy, adding treatment, in July 2020 to monotherapy without clinical approval, the current domestic perampanel monotherapy clinical effectiveness and safety of focal epilepsy in children have not been reported. | Drug | – |
Primary outcome
clinical efficacy after drug treatment:
Time frame: one year
Epilepsy seizures: the seizure frequency 3 months before treatment is the baseline, and the maintenance period is compared with the baseline. Complete control: no seizures after treatment; markedly effective: seizure frequency reduced by > 75%; effective: seizure frequency reduced by > 51%-74 %; Ineffective: frequency reduced by ≤50%, worsening: attack frequency increased by 25%.
EEG changes after drug treatment
Time frame: one year
EEG changes: (1) normal EEG (2) abnormal EEG: including epileptiform discharge, background rhythm slowing, epileptiform discharge + background rhythm slowing. EEG judgment: (1) normal: the epileptiform discharge disappeared or the background slowing disappeared (2) effective: the epileptiform discharge was reduced or the background slowing was improved (3) invalid: the epileptiform discharge did not change or aggravate after the drug.
safety after drug treatment
Time frame: one year
Common adverse reactions include: dizziness, drowsiness, fatigue, irritability, nausea and falls and weight gain.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2022.
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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.
xinwei yang, doctor principal investigator
hospital doctor
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 Focal Epilepsy, run by Yang Xinwei at 1 site in China.
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 11 Aug 2022. 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 China. 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?
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?
clinical efficacy after drug treatment: (time frame: one year). The study lists 3 primary outcomes in all. 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 11 Aug 2022.