A Study of Perampanel as Add-on Therapy in Adult and Adolescent Participants With Focal Seizures

NCT04257604 | Completed FDA Drug

• 1 other identifier: E2007-M044-501
• Study Type: observational
• Target: 243
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Partial Seizures

Keywords

Perampanel; Partial seizures; Focal seizures

Outcome Measures

Primary Outcomes (1)

• Percentage Change From Baseline in all Seizures Frequency at Month 6

  Seizure frequency is derived from information (seizure count and type) recorded in participant diary. Seizure frequency is based on the number of seizures per 28 days, calculated as the number of seizures over the entire time interval divided by the number of days in the interval and multiplied by 28.

  Baseline, Month 6

Secondary Outcomes (14)

• Percentage of Participants Remaining on Perampanel at Months 6 and 12

  Months 6 and 12

• Percentage of Participants With Adverse Drug Reactions (ADRs) and Serious Adverse Drug Reactions (SADRs)

  Up to Month 12

• Percentage of Participants Who Withdraw due to ADR

  Up to Month 12

• Percentage of Participants Who Withdraw due to Lack of Efficacy

  Up to Month 12

• Mean Change From Baseline in the Number of Concomitant Anti-epileptic Drugs (AEDs)

  Baseline up to Month 12

Study Arms (1)

Perampanel

Participants with partial-onset seizures, with or without secondary generalization will receive perampanel tablets as add-on therapy according to the approved summary of product characteristics (SmPC) after the baseline visit as part of the clinical practice and will be observed after 3 months (visit 1), 6 months (visit 2), and 12 months (final visit).

Drug: Perampanel

Interventions

Perampanel DRUG

Perampanel tablets.

Also known as: Fycompa, E2007

Perampanel

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants with epilepsy aged 12 years or older.

You may qualify if:

• Prescribe perampanel according to the approved indication
• Participants with focal seizures with or without secondary generalization
• Participants with seizure frequency data available at the baseline visit
• 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
• The decision to prescribe perampanel is made by the physician before and independently of his/her decision to include the participant in the study
• Treatment with perampanel is not yet started before baseline

You may not qualify if:

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

Sponsors & Collaborators

• Eisai Limited: lead

MeSH Terms

Conditions

Seizures

Interventions

perampanel

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2020
• First Posted: February 6, 2020
• Study Start: January 3, 2016
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2019
• Last Updated: February 6, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share