Clinical trial NCT04257604: A Study of Perampanel as Add-on Therapy in Adult and Adolescent Participants With Focal Seizures
Official title: A Multicenter, Prospective, Real-life Observational Study of Perampanel as Add-on Therapy in Adult and Adolescent Patients With Focal Seizures (A Mirroring Clinical Practice Study of Perampanel in Adults and Adolescents) (The AMPA Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Partial Seizures
Keywords: Perampanel
Partial seizures
Focal seizures
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2020-02-06
Enrollment: 243
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with epilepsy aged 12 years or older.

Brief summary: The primary objective of the present study will be to assess the effectiveness of add-on perampanel in participants with focal seizures in a real-life clinical setting.


Eligibility criteria: Inclusion Criteria:

1. Prescribe perampanel according to the approved indication
2. Participants with focal seizures with or without secondary generalization
3. Participants with seizure frequency data available at the baseline visit
4. Based on the physician's clinical judgment, the participant seizure activity is not controlled sufficiently with the current treatment with 1-3 AEDs and it is in the participants best interest to be prescribed adjunctive perampanel
5. The decision to prescribe perampanel is made by the physician before and independently of his/her decision to include the participant in the study
6. Treatment with perampanel is not yet started before baseline

Exclusion Criteria:

1. Participants contraindicated for perampanel use (according to SmPC)
2. Participants with moderate to severe renal impairment
3. Participants with severe hepatic impairment
4. Pregnant or lactating women
5. Participants suffering from clinically significant psychiatric illness, psychological or behavioral problems which could interfere with study participation

Primary outcomes:
measure: Percentage Change From Baseline in all Seizures Frequency at Month 6
timeFrame: Baseline, Month 6
Secondary outcomes:
measure: Percentage of Participants Remaining on Perampanel at Months 6 and 12
timeFrame: Months 6 and 12
measure: Percentage of Participants With Adverse Drug Reactions (ADRs) and Serious Adverse Drug Reactions (SADRs)
timeFrame: Up to Month 12
measure: Percentage of Participants Who Withdraw due to ADR
timeFrame: Up to Month 12
measure: Percentage of Participants Who Withdraw due to Lack of Efficacy
timeFrame: Up to Month 12
measure: Mean Change From Baseline in the Number of Concomitant Anti-epileptic Drugs (AEDs)
timeFrame: Baseline up to Month 12
measure: Percentage of Participants With at Least 50 Percent (%) and 75% Reduction From Baseline in All Seizure Frequency at Months 3, 6 and 12
timeFrame: Baseline, Months 3, 6, and 12
measure: Percentage of Participants With at Least 50% and 75% Reduction From Baseline in Secondarily Generalized Tonic-clonic Seizures (SGTCS) Frequency at Months 3, 6 and 12
timeFrame: Baseline, Months 3, 6, and 12
measure: Percentage of Participants Who Were Seizure-free
timeFrame: Up to Month 12
measure: Median Percentage Change From Baseline in All Seizure Frequency at Months 3 and 12
timeFrame: Baseline, Months 3 and 12
measure: Median Percentage Change From Baseline in SGTCS Frequency at Months 3, 6 and 12
timeFrame: Baseline, Months 3, 6, and 12
measure: Mean Change From Baseline in 31-item Quality of Life in Epilepsy (QOLIE-31) Questionnaire Score in Adult Participants at Month 6 and 12
timeFrame: Baseline, Months 6 and 12
measure: Mean Change From Baseline in Epworth Sleepiness Scale (ESS) Score in Adult Participants at Months 3, 6, and 12
timeFrame: Baseline, Months 3, 6, and 12
measure: Mean Change From Baseline in Irritability With Epilepsy Questionnaire Score (I-Epi) in Adult Participants at Months 3, 6, and 12
timeFrame: Baseline, Months 3, 6, and 12
measure: Regression Coefficient For Predictive Factors in Response to Perampanel
timeFrame: Up to Month 12
Other outcomes:
Locations:
Study officials:
References: