Trial Outcomes & Findings for Perampanel for the Reduction of Seizure Frequency in Patients With High-grade Glioma and Focal Epilepsy (NCT NCT04650204)

Last Updated: 2023-06-22

Results Overview

Will compare seizure frequency before and 3 months after treatment with monotherapy and adjunctive PER and use descriptive statistics to demonstrate differences in responders. A P-value \< 0.05 will be used to reflect statistical significance.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

4 participants

Primary outcome timeframe

At 3 months

Results posted on

2023-06-22

Participant Flow

Participant milestones

Participant milestones
Measure	Arm A (Perampanel) Patients receive perampanel PO QD for 40 weeks in the absence of disease progression or unacceptable toxicity. Perampanel: Given PO Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies	Arm B (ASD) Patients receive ASD per standard of care for 40 weeks in the absence of disease progression or unacceptable toxicity. Anticonvulsant Agent: Given ASD Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
Overall Study STARTED	3	1
Overall Study COMPLETED	1	0
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A (Perampanel) Patients receive perampanel PO QD for 40 weeks in the absence of disease progression or unacceptable toxicity. Perampanel: Given PO Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies	Arm B (ASD) Patients receive ASD per standard of care for 40 weeks in the absence of disease progression or unacceptable toxicity. Anticonvulsant Agent: Given ASD Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
Overall Study Study was Terminated	2	1

Baseline Characteristics

Perampanel for the Reduction of Seizure Frequency in Patients With High-grade Glioma and Focal Epilepsy

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: At 3 months

Population: 1 participant was randomized to Arm B, but did not complete the 3 month follow-up due to study termination. In Arm A, only 2 participants met the study 3 month mark prior to study termination.

Outcome measures

Outcome measures
Measure	Arm A (Perampanel) n=2 Participants Patients receive perampanel PO QD for 40 weeks in the absence of disease progression or unacceptable toxicity. Perampanel: Given PO Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies	Arm B (ASD) Patients receive ASD per standard of care for 40 weeks in the absence of disease progression or unacceptable toxicity. Anticonvulsant Agent: Given ASD Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
Number of Patients With a High-grade Glioma Who Achieve a > 50% Reduction in Focal Seizures With Perampanel (PER) 4 mg Daily After Failing 1 or More Anti-seizure Drugs (ASDs)	1 Participants	—

PRIMARY outcome

Timeframe: At 6 months

Population: 1 participant was randomized to Arm B, but did not complete the 6 month follow-up due to study termination. In Arm A, only 1 participant met the study 6 month mark prior to study termination.

Will compare seizure frequency before and 6 months after treatment with monotherapy and adjunctive PER and use descriptive statistics to demonstrate differences in responders. A P-value \< 0.05 will be used to reflect statistical significance.

Outcome measures

Outcome measures
Measure	Arm A (Perampanel) n=1 Participants Patients receive perampanel PO QD for 40 weeks in the absence of disease progression or unacceptable toxicity. Perampanel: Given PO Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies	Arm B (ASD) Patients receive ASD per standard of care for 40 weeks in the absence of disease progression or unacceptable toxicity. Anticonvulsant Agent: Given ASD Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
Number of Patients With a High-grade Glioma Who Achieve a > 50% Reduction in Focal Seizures With PER 4 mg Daily After Failing 1 or More ASDs	1 Participants	—

PRIMARY outcome

Timeframe: At 3 months

Population: 1 participant was randomized to Arm B, but did not receive PER treatment. In Arm A, only 2 participants met the study 3 month mark prior to study termination.

Chi-square and Student T-test will be used to measure differences in assessment and change during the study period.

Outcome measures

Outcome measures
Measure	Arm A (Perampanel) n=2 Participants Patients receive perampanel PO QD for 40 weeks in the absence of disease progression or unacceptable toxicity. Perampanel: Given PO Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies	Arm B (ASD) Patients receive ASD per standard of care for 40 weeks in the absence of disease progression or unacceptable toxicity. Anticonvulsant Agent: Given ASD Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
Number of Participants Alive at 3 Months With High-grade Glioma Treated With PER	2 Participants	—

PRIMARY outcome

Timeframe: At 6 months

Population: The study was terminated due to the funding sponsor no longer being able to provide study medication. Data for this outcome measure was not collected nor analyzed.

Chi-square and Student T-test will be used to measure differences in assessment and change during the study period.

Outcome measures

Outcome data not reported

Adverse Events

Arm A (Perampanel)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Arm B (ASD)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Arm A (Perampanel) n=3 participants at risk Patients receive perampanel PO QD for 40 weeks in the absence of disease progression or unacceptable toxicity. Perampanel: Given PO Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies	Arm B (ASD) n=1 participants at risk Patients receive ASD per standard of care for 40 weeks in the absence of disease progression or unacceptable toxicity. Anticonvulsant Agent: Given ASD Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
Nervous system disorders Imbalance & problems with coordination	33.3% 1/3 • Number of events 1 • Adverse events were collected from a baseline to end of study participation for approximately 12 months on all participants.	0.00% 0/1 • Adverse events were collected from a baseline to end of study participation for approximately 12 months on all participants.
Renal and urinary disorders Urinary Incontinence	33.3% 1/3 • Number of events 1 • Adverse events were collected from a baseline to end of study participation for approximately 12 months on all participants.	0.00% 0/1 • Adverse events were collected from a baseline to end of study participation for approximately 12 months on all participants.
General disorders Valproic acid Toxicity	33.3% 1/3 • Number of events 1 • Adverse events were collected from a baseline to end of study participation for approximately 12 months on all participants.	0.00% 0/1 • Adverse events were collected from a baseline to end of study participation for approximately 12 months on all participants.
Nervous system disorders Headaches	33.3% 1/3 • Number of events 1 • Adverse events were collected from a baseline to end of study participation for approximately 12 months on all participants.	0.00% 0/1 • Adverse events were collected from a baseline to end of study participation for approximately 12 months on all participants.
General disorders Fever	33.3% 1/3 • Number of events 1 • Adverse events were collected from a baseline to end of study participation for approximately 12 months on all participants.	0.00% 0/1 • Adverse events were collected from a baseline to end of study participation for approximately 12 months on all participants.
General disorders Fatigue	33.3% 1/3 • Number of events 1 • Adverse events were collected from a baseline to end of study participation for approximately 12 months on all participants.	0.00% 0/1 • Adverse events were collected from a baseline to end of study participation for approximately 12 months on all participants.

Additional Information

William Tatum, D.O.

Mayo Clinic

Phone: 507 284-2511

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Arm A (Perampanel) n=3 Participants Patients receive perampanel PO QD for 40 weeks in the absence of disease progression or unacceptable toxicity. Perampanel: Given PO Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies	Arm B (ASD) n=1 Participants Patients receive ASD per standard of care for 40 weeks in the absence of disease progression or unacceptable toxicity. Anticonvulsant Agent: Given ASD Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies	Total n=4 Participants Total of all reporting groups
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants	1 participants n=7 Participants	4 participants n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants