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A China RWS to Evaluate the Effectiveness and Safety of Perampanel as an add-on Treatment for Epileptic Seizure

Sponsor
Beijing Children's Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05257915
Collaborator
(none)
600
Enrollment
5
Locations
17.9
Anticipated Duration (Months)
120
Patients Per Site
6.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is a real-word clinical trial. The purpose of this study is to evaluate the effectiveness and safety of perampanel as an add-on treatment for epileptic seizure. The enrolled subjects were epilepsy patients 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.

Condition or Disease Intervention/Treatment Phase

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 600 patients with epilepsy who are eligible for inclusion enrollment and receiving Perampenal from January 2021 to October 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

Study Type:
Observational
Actual Enrollment :
600 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Real-world Clinical Study to Evaluate the Effectiveness and Safety of Perampanel as an add-on Treatment for Epileptic Seizure
Actual Study Start Date :
Jan 1, 2021
Actual Primary Completion Date :
Oct 31, 2021
Anticipated Study Completion Date :
Jun 30, 2022

Arms and Interventions

Arm Intervention/Treatment
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.

Drug: Perampanel
For patients ≥12 years old, the initial dose is 2 mg/d, and according to the clinical response and tolerance of the patient, the dose is increased to the minimum clinically effective dose in increments of 2 mg, and the interval between dose increases is not less than 2 weeks. For patients <12 years, according to the actual clinical situation, the initial dose and addition plan are judged by the investigator.
Other Names:
  • Fycompa

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 50% response rate of Perampanel [6 months]

      Proportion of subjects who have at least 50% reduction in total seizure frequency during the Maintenance Period relative to the Baseline

    Secondary Outcome Measures

    1. Seizure-free rate of Perampanel [6 months]

      Proportion of subjects who achieve seizure-free status for total seizure during the Maintenance Period

    2. Retention rate of Perampanel [6 months]

      Percentage of subjects still using perampanel after the Maintenance Period

    3. Safety and Tolerability [6 months]

      Incidence of all of adverse events (AEs), serious adverse events (SAEs) and discontinuation from treatment

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Within 1 year 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;

    • Follow up for at least 3 months;

    • Sign informed consent (if necessary).

    Exclusion Criteria:

    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beijing Children's Hospital, Capital Medical University Beijing Beijing China 100045
    2 Beijing TianTan Hospital, Capital Medical University Beijing Beijing China
    3 Beijing University First Hospital Beijing Beijing China
    4 Peking Union Medical College Hospital Beijing Beijing China
    5 Peking University People's Hospital Beijing Beijing China

    Sponsors and Collaborators

    • Beijing Children's Hospital

    Investigators

    • Study Chair: Fang Fang, Beijing Children's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xiaodan Li, MD, Resident, Beijing Children's Hospital
    ClinicalTrials.gov Identifier:
    NCT05257915
    Other Study ID Numbers:
    • BCHsjk-2020-Z-151
    First Posted:
    Feb 25, 2022
    Last Update Posted:
    Feb 25, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Xiaodan Li, MD, Resident, Beijing Children's Hospital
    Epilepsy
    Perampanel
    Additional relevant MeSH terms:
    Epilepsy
    Seizures

    Study Results

    No Results Posted as of Feb 25, 2022