A Study to Evaluate the Safety and Efficacy of Fycompa® (Perampanel) as Add-on Therapy in Participants With Epilepsy

Epilepsy Clinical Trial

Official title:

A Post Marketing Observational Study to Evaluate the Safety and Efficacy of Fycompa® (Perampanel) as Add-on Therapy in Epilepsy Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04230044
• Other study ID #: E2007-M065-411
• Status: Completed
• Start date: April 11, 2016
• Est. completion date: July 3, 2017

Study information

• Verified date: November 2019
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of the study is to evaluate the safety and efficacy of Fycompa® (perampanel) for the adjunctive treatment of partial-onset seizures with or without secondarily generalized seizures in participants with epilepsy aged 12 years and older.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: July 3, 2017
• Est. primary completion date: July 3, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

1. Male and female participants aged 12 years and older

2. Participants who were diagnosed with partial-onset seizures with or without secondarily generalized seizures.

3. Participants who were appropriate to receive Fycompa® as an adjunctive treatment participants starting at Visit 0 according to investigator's judgment.

4. Participants who had provided written informed consent

Exclusion Criteria:

1. Participants not fit to receive Fycompa® as per the latest prescribing information.

2. Participants who were participating in a clinical trial, at the time of the study.

3. Participants who showed evidence of clinically significant disease (cardiac, respiratory, gastrointestinal, renal disease, etc.) that in the opinion of the Investigators could affect the participant's safety or trial conduct.

4. Participants who according to the Investigators would not be able to comply with study procedures.

Related Conditions & MeSH terms

• Epilepsy
• Partial-onset Seizures
• Seizures

Intervention

Drug:
• Perampanel
Perampanel tablets.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)	AESI will include medication errors, lack of therapeutic efficacy, overdose, abuse, misuse, occupational exposure, paternal exposure and off label use, pregnancy, and exposure to drug during breast feeding.	Up to 54 Weeks
Secondary	Change From Baseline in 28-day Seizure Count at the End of Treatment Period (Week 52)		Baseline, Week 52
Secondary	Response Rate	Response rate will be defined as number of participants with response defined as more than or equal to (>=) 50 percent (%) reduction in 28-day seizure frequency from Baseline.	Baseline, Week 12, Week 24 and Week 52
Secondary	Change From Baseline in Clinical Global Impression of Change (CGIC) Scores	The CGIC is an assessment performed by the clinician, evaluating the change in the participant's symptoms over time. Assessment will be implemented based on frequency of seizure, severity of seizures, adverse events, and overall conditions on a 7-point scale with the scores as 1: very much improved, 2: much improved, 3: minimally improved, 4: no change, 5: minimally worse, 6: much worse, 7: very much worse.	Baseline, Week 12, Week 24 and Week 52