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

Epilepsy Clinical Trial

Official title:

A Real-world Clinical Study to Evaluate the Effectiveness and Safety of Perampanel as an add-on Treatment for Epileptic Seizure

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05257915
• Other study ID #: BCHsjk-2020-Z-151
• Status: Active, not recruiting
• Start date: January 1, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: February 2022
• Source: Beijing Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 600
• Est. completion date: June 30, 2022
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy
• Seizures

Intervention

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.

Locations

Country	Name	City	State
China	Beijing Children's Hospital, Capital Medical University	Beijing	Beijing
China	Beijing TianTan Hospital, Capital Medical University	Beijing	Beijing
China	Beijing University First Hospital	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing
China	Peking University People's Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Children's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 months
Secondary	Seizure-free rate of Perampanel	Proportion of subjects who achieve seizure-free status for total seizure during the Maintenance Period	6 months
Secondary	Retention rate of Perampanel	Percentage of subjects still using perampanel after the Maintenance Period	6 months
Secondary	Safety and Tolerability	Incidence of all of adverse events (AEs), serious adverse events (SAEs) and discontinuation from treatment	6 months