EpilepsyNCT05274035
A Multi-center RWS of Perampanel as an add-on Treatment for Epileptic Seizures in Chinese Children
An observational study of Epilepsy, run by Beijing Children's Hospital at 5 sites in China.
Trial summary
This study is a multi-center, real-word clinical trial. The purpose of this study is to evaluate the safety and effectiveness of perampanel as an add-on treatment for epileptic seizure, and to find the effective maintenance and maximum dose in Chinese children. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Perampanel
- How many people
- 1,000 participants
- Where
- 5 sitesChina
- Study dates
- 2 Jul 2021to 31 Jul 2022
- 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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: epilepsy patients between 2 and 12 years of age who had failed clinical treatment with 1-3 anti-epileptic drugs (AEDs) with the optimal dose and course of treatment and needed additional treatment.
Who may be able to join
- Age ≥2y, ≤12y;
- Within 3 months before taking perampanel, the frequency of epileptic seizures was ≥1 time/month on average;
- 1-3 kinds of AEDs have been used, and the optimal dose and course of treatment have been reached, but the effect is not good. Perampanel is used as an additional treatment.
Who cannot join
- Patients who have participated in other researches on antiepileptic drugs or medical devices;
- Inaccurate or unreliable clinical records according to the judgment of participating doctors;
- When the database is closed, the expected follow-up time is less than 6 months.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Beijing Children's Hospital, Capital Medical University
Beijing, Beijing Municipality, 100045
Jinan Children's Hospital
Jinan, Shandong, 250022
Tianjin Children's Hospital
Tianjin, Tianjin Municipality, 300134
Wuhan Children's Hospital, Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430015
XuZhou Children's Hospital
Xuzhou, Jiangsu, 221002
About this study
Official title: A Multi-center, Real-world Clinical Study of Perampanel as an add-on Treatment for Epileptic Seizures in Chinese Children
This study is a multi-center, real-word clinical trial. The purpose of this study is to evaluate the safety and effectiveness of perampanel as an add-on treatment for epileptic seizure, and to find the effective maintenance and maximum dose in Chinese children. The enrolled subjects were epilepsy patients between 2 and 12 years of age who had failed clinical treatment with 1-3 anti-epileptic drugs (AEDs) with the optimal dose and course of treatment and needed additional treatment. The study was a real-world prospective clinical study, and the initial and maximum doses of perampanel were individualized by neurologists according to the patient's clinical situation.
Read the detailed description
This is a multi-center, prospective, observational study. Subjects who meet all of the inclusion and none of the exclusion criteria will be received perampanel. Baseline seizure counts (frequency) data is collected by subjects or guardian/legally authorized representative, retrospectively.
It is expected to enroll 1000 patients with epilepsy who are eligible for inclusion enrollment and receiving Perampenal from July 2021 to November 2021. The initial and maximum doses of perampanel were individualized by neurologists according to the patient's clinical situation. The patients were followed up for 6 months and recorded the frequency of seizures and self-assessment of improvement. Safety will be assessed by monitoring and recording of all of AEs and serious adverse events (SAEs), discontinuation during 6 months treatment (patient spontaneous reporting).
- Conditions
- Epilepsy
- Being tested
- Perampanel
- Keywords
- Epilepsy, Perampanel
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PerampanelDrug
Also called Fycompa
For children ≥4 years old, the initial dose is 2 mg per day, the titration interval is ≥2 weeks, the daily dose is increased by 2 mg each time (based on clinical response and tolerability), and the maintenance dose is ≥4 mg per day, up to a maximum dose of 12 mg per day.
For children <4 years old, the initial dose is 0.04 mg/kg per day, the titration interval is ≥ 2 weeks, the daily dose is increased by 0.04 mg/kg each time (based on clinical response and tolerability), and the maintenance dose is ≥ 0.08 mg/day per day kg, the highest dose is 0.24 mg/kg per day.
According to the actual clinical situation, the initial dose and addition plan are judged by the investigator.
| Study group | Role | What they receive |
|---|---|---|
| Perampanel | Epilepsy patients who had failed clinical treatment with 1-3 anti-epileptic drugs (AEDs) with the optimal dose and course of treatment and needed perampanel additional treatment. Receives: Drug: Perampanel |
What is being measured
The primary outcome is the main question the study is designed to answer.
50% response rate of Perampanel
Proportion of subjects who have at least 50% reduction in total seizure frequency during the Maintenance Period relative to the Baseline
Measured: 6 months
Secondary outcomes (3)
Seizure-free rate of Perampanel
Proportion of subjects who achieve seizure-free status for total seizure during the Maintenance Period
Measured: 6 months
Retention rate of Perampanel
Percentage of subjects still using perampanel after the Maintenance Period
Measured: 6 months
Incidence of AEs and discontinuation [Safety and Tolerability]
Incidence of all of adverse events (AEs), serious adverse events (SAEs) and discontinuation from treatment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start2 Jul 2021
- Primary completion15 Nov 2021
- Study completion31 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaodan Li, MD, Beijing Children's Hospital
- Investigators
- Fang Fang, Study chair, Beijing Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05274035
- Sponsor's protocol ID
- BCHsjk-2021-E-108-Y
- Status last verified
- Mar 2022
- First submitted
- 2 Mar 2022
- Last updated
- 25 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Real-world Clinical Study of Perampanel as an add-on Treatment for Epileptic Seizures in Chinese Children
- ClinicalTrials.gov ID
- NCT05274035
- Acronym / sponsor ID
- BCHsjk-2021-E-108-Y
- Conditions
- Epilepsy
- Keywords
- Epilepsy, Perampanel
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Beijing Children's HospitalUniversity, hospital or other
- Study start
- 2 Jul 2021 (actual)
- Primary completion
- 15 Nov 2021 (actual)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 10 Mar 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 study is a multi-center, real-word clinical trial. The purpose of this study is to evaluate the safety and effectiveness of perampanel as an add-on treatment for epileptic seizure, and to find the effective maintenance and maximum dose in Chinese children. The enrolled subjects were epilepsy patients between 2 and 12 years of age who had failed clinical treatment with 1-3 anti-epileptic drugs (AEDs) with the optimal dose and course of treatment and needed additional treatment. The study was a real-world prospective clinical study, and the initial and maximum doses of perampanel were individualized by neurologists according to the patient's clinical situation.
Detailed description
This is a multi-center, prospective, observational study. Subjects who meet all of the inclusion and none of the exclusion criteria will be received perampanel. Baseline seizure counts (frequency) data is collected by subjects or guardian/legally authorized representative, retrospectively.
It is expected to enroll 1000 patients with epilepsy who are eligible for inclusion enrollment and receiving Perampenal from July 2021 to November 2021. The initial and maximum doses of perampanel were individualized by neurologists according to the patient's clinical situation. The patients were followed up for 6 months and recorded the frequency of seizures and self-assessment of improvement. Safety will be assessed by monitoring and recording of all of AEs and serious adverse events (SAEs), discontinuation during 6 months treatment (patient spontaneous reporting).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Perampanel | – | Drug: PerampanelEpilepsy patients who had failed clinical treatment with 1-3 anti-epileptic drugs (AEDs) with the optimal dose and course of treatment and needed perampanel additional treatment. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- epilepsy patients between 2 and 12 years of age who had failed clinical treatment with 1-3 anti-epileptic drugs (AEDs) with the optimal dose and course of treatment and needed additional treatment.
Key inclusion criteria (3 listed)
- Age ≥2y, ≤12y;
- Within 3 months before taking perampanel, the frequency of epileptic seizures was ≥1 time/month on average;
- 1-3 kinds of AEDs have been used, and the optimal dose and course of treatment have been reached, but the effect is not good. Perampanel is used as an additional treatment.
Key exclusion criteria (3 listed)
- Patients who have participated in other researches on antiepileptic drugs or medical devices;
- Inaccurate or unreliable clinical records according to the judgment of participating doctors;
- When the database is closed, the expected follow-up time is less than 6 months.
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: FycompaFor children ≥4 years old, the initial dose is 2 mg per day, the titration interval is ≥2 weeks, the daily dose is increased by 2 mg each time (based on clinical response and tolerability), and the maintenance dose is ≥4 mg per day, up to a maximum dose of 12 mg per day. For children <4 years old, the initial dose is 0.04 mg/kg per day, the titration interval is ≥ 2 weeks, the daily dose is increased by 0.04 mg/kg each time (based on clinical response and tolerability), and the maintenance dose is ≥ 0.08 mg/day per day kg, the highest dose is 0.24 mg/kg per day. According to the actual clinical situation, the initial dose and addition plan are judged by the investigator. | Drug | Perampanel |
Primary outcome
50% response rate of Perampanel
Time frame: 6 months
Proportion of subjects who have at least 50% reduction in total seizure frequency during the Maintenance Period relative to the Baseline
3 secondary outcomes
Seizure-free rate of Perampanel
Time frame: 6 months
Retention rate of Perampanel
Time frame: 6 months
Incidence of AEs and discontinuation [Safety and Tolerability]
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2022.
- Individual participant dataSharing planned: No
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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.
Fang Fang study chair
Beijing Children's Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by Beijing Children's Hospital at 5 sites 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 3 inclusion and 3 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 25 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
50% response rate of Perampanel (time frame: 6 months). 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 25 Mar 2022.