Trial Outcomes & Findings for Effect of Perampanel on Peritumoral Hyperexcitability in HGG (NCT NCT04497142)

Last Updated: 2024-08-05

Results Overview

Peritumoral hyperexcitability was measured by intraoperative electrocorticography (ECoG) high frequency oscillation (80-500 Hz) rate over 10 minutes within 1 cm of the contrast-enhancing margin at the time of initial glioma resection.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

12 participants

Primary outcome timeframe

Peri-operative

Results posted on

2024-08-05

Participant Flow

Participant milestones

Participant milestones
Measure	Perampanel + Electrocorticography Perampanel 6mg on day prior to resection, 4mg pre-op prior to resection, and 4mg daily until PD or up to 12 months. Intraoperative ECoG with 20 contact subdural grid performed for analysis of high frequency oscillation (80-500 Hz) rate.	Standard of Care + Electrocorticography Levetiracetam peri-operatively per standard of care. Intraoperative ECoG with 20 contact subdural grid performed for analysis of high frequency oscillation (80-500 Hz) rate.
Overall Study STARTED	8	4
Overall Study COMPLETED	7	4
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Perampanel on Peritumoral Hyperexcitability in HGG

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Peri-operative

Population: 1 participant (perampanel arm) was excluded from analysis after pathology revealed a non-glial tumor

Outcome measures

Outcome measures
Measure	Perampanel + Electrocorticography n=7 Participants Perampanel 6mg on day prior to resection, 4mg pre-op prior to resection, and 4mg daily until PD or up to 12 months. Intraoperative ECoG with 20 contact subdural grid performed for analysis of high frequency oscillation (80-500 Hz) rate.	Standard of Care + Electrocorticography n=4 Participants Levetiracetam peri-operatively per standard of care. Intraoperative ECoG with 20 contact subdural grid performed for analysis of high frequency oscillation (80-500 Hz) rate.
Peritumoral HFO Rate	2.5 HFOs per minute Interval 0.0 to 5.6	1.4 HFOs per minute Interval 0.4 to 3.0

SECONDARY outcome

Timeframe: From time of initial surgery to PD or up to 12 months

Seizure-free rates were assessed from the time of initial glioma resection to radiographic tumor progression or up to a maximum of 12 months.

Outcome measures

Outcome measures
Measure	Perampanel + Electrocorticography n=7 Participants Perampanel 6mg on day prior to resection, 4mg pre-op prior to resection, and 4mg daily until PD or up to 12 months. Intraoperative ECoG with 20 contact subdural grid performed for analysis of high frequency oscillation (80-500 Hz) rate.	Standard of Care + Electrocorticography n=4 Participants Levetiracetam peri-operatively per standard of care. Intraoperative ECoG with 20 contact subdural grid performed for analysis of high frequency oscillation (80-500 Hz) rate.
Seizure-freedom	1 Participants	2 Participants

Adverse Events

Perampanel + Electrocorticography

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Standard of Care + Electrocorticography

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Steven Tobochnik, MD

Brigham and Women's Hospital

Phone: 617-732-7432

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Perampanel + Electrocorticography n=8 Participants Perampanel 6mg on day prior to resection, 4mg pre-op prior to resection, and 4mg daily until PD or up to 12 months. Intraoperative ECoG with 20 contact subdural grid performed for analysis of high frequency oscillation (80-500 Hz) rate.	Standard of Care + Electrocorticography n=4 Participants Levetiracetam peri-operatively per standard of care. Intraoperative ECoG with 20 contact subdural grid performed for analysis of high frequency oscillation (80-500 Hz) rate.	Total n=12 Participants Total of all reporting groups
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
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 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) White	7 Participants n=5 Participants	4 Participants n=7 Participants	11 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	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

Measure	Perampanel + Electrocorticography n=8 participants at risk Perampanel 6mg on day prior to resection, 4mg pre-op prior to resection, and 4mg daily until PD or up to 12 months. Intraoperative ECoG with 20 contact subdural grid performed for analysis of high frequency oscillation (80-500 Hz) rate.	Standard of Care + Electrocorticography n=4 participants at risk Levetiracetam peri-operatively per standard of care. Intraoperative ECoG with 20 contact subdural grid performed for analysis of high frequency oscillation (80-500 Hz) rate.
Psychiatric disorders Agitation	12.5% 1/8 • From the time of enrollment to PD or up to 12 months According to NCI CTCAE 5.0. Seizures were not considered adverse events per protocol as they were defined as a secondary outcome.	0.00% 0/4 • From the time of enrollment to PD or up to 12 months According to NCI CTCAE 5.0. Seizures were not considered adverse events per protocol as they were defined as a secondary outcome.
Psychiatric disorders Anxiety	12.5% 1/8 • From the time of enrollment to PD or up to 12 months According to NCI CTCAE 5.0. Seizures were not considered adverse events per protocol as they were defined as a secondary outcome.	25.0% 1/4 • From the time of enrollment to PD or up to 12 months According to NCI CTCAE 5.0. Seizures were not considered adverse events per protocol as they were defined as a secondary outcome.
Nervous system disorders Cognitive disturbance	12.5% 1/8 • From the time of enrollment to PD or up to 12 months According to NCI CTCAE 5.0. Seizures were not considered adverse events per protocol as they were defined as a secondary outcome.	0.00% 0/4 • From the time of enrollment to PD or up to 12 months According to NCI CTCAE 5.0. Seizures were not considered adverse events per protocol as they were defined as a secondary outcome.
Nervous system disorders Concentration impairment	25.0% 2/8 • From the time of enrollment to PD or up to 12 months According to NCI CTCAE 5.0. Seizures were not considered adverse events per protocol as they were defined as a secondary outcome.	0.00% 0/4 • From the time of enrollment to PD or up to 12 months According to NCI CTCAE 5.0. Seizures were not considered adverse events per protocol as they were defined as a secondary outcome.
Gastrointestinal disorders Constipation	12.5% 1/8 • From the time of enrollment to PD or up to 12 months According to NCI CTCAE 5.0. Seizures were not considered adverse events per protocol as they were defined as a secondary outcome.	0.00% 0/4 • From the time of enrollment to PD or up to 12 months According to NCI CTCAE 5.0. Seizures were not considered adverse events per protocol as they were defined as a secondary outcome.
Psychiatric disorders Depression	12.5% 1/8 • From the time of enrollment to PD or up to 12 months According to NCI CTCAE 5.0. Seizures were not considered adverse events per protocol as they were defined as a secondary outcome.	25.0% 1/4 • From the time of enrollment to PD or up to 12 months According to NCI CTCAE 5.0. Seizures were not considered adverse events per protocol as they were defined as a secondary outcome.
Nervous system disorders Dizziness	12.5% 1/8 • From the time of enrollment to PD or up to 12 months According to NCI CTCAE 5.0. Seizures were not considered adverse events per protocol as they were defined as a secondary outcome.	0.00% 0/4 • From the time of enrollment to PD or up to 12 months According to NCI CTCAE 5.0. Seizures were not considered adverse events per protocol as they were defined as a secondary outcome.
General disorders Fatigue	37.5% 3/8 • From the time of enrollment to PD or up to 12 months According to NCI CTCAE 5.0. Seizures were not considered adverse events per protocol as they were defined as a secondary outcome.	50.0% 2/4 • From the time of enrollment to PD or up to 12 months According to NCI CTCAE 5.0. Seizures were not considered adverse events per protocol as they were defined as a secondary outcome.
General disorders Gait disturbance	12.5% 1/8 • From the time of enrollment to PD or up to 12 months According to NCI CTCAE 5.0. Seizures were not considered adverse events per protocol as they were defined as a secondary outcome.	0.00% 0/4 • From the time of enrollment to PD or up to 12 months According to NCI CTCAE 5.0. Seizures were not considered adverse events per protocol as they were defined as a secondary outcome.
Nervous system disorders Headache	12.5% 1/8 • From the time of enrollment to PD or up to 12 months According to NCI CTCAE 5.0. Seizures were not considered adverse events per protocol as they were defined as a secondary outcome.	25.0% 1/4 • From the time of enrollment to PD or up to 12 months According to NCI CTCAE 5.0. Seizures were not considered adverse events per protocol as they were defined as a secondary outcome.
Nervous system disorders Hypersomnia	12.5% 1/8 • From the time of enrollment to PD or up to 12 months According to NCI CTCAE 5.0. Seizures were not considered adverse events per protocol as they were defined as a secondary outcome.	0.00% 0/4 • From the time of enrollment to PD or up to 12 months According to NCI CTCAE 5.0. Seizures were not considered adverse events per protocol as they were defined as a secondary outcome.
Psychiatric disorders Irritability	12.5% 1/8 • From the time of enrollment to PD or up to 12 months According to NCI CTCAE 5.0. Seizures were not considered adverse events per protocol as they were defined as a secondary outcome.	25.0% 1/4 • From the time of enrollment to PD or up to 12 months According to NCI CTCAE 5.0. Seizures were not considered adverse events per protocol as they were defined as a secondary outcome.
Gastrointestinal disorders Mucositis oral	12.5% 1/8 • From the time of enrollment to PD or up to 12 months According to NCI CTCAE 5.0. Seizures were not considered adverse events per protocol as they were defined as a secondary outcome.	0.00% 0/4 • From the time of enrollment to PD or up to 12 months According to NCI CTCAE 5.0. Seizures were not considered adverse events per protocol as they were defined as a secondary outcome.
Gastrointestinal disorders Nausea	0.00% 0/8 • From the time of enrollment to PD or up to 12 months According to NCI CTCAE 5.0. Seizures were not considered adverse events per protocol as they were defined as a secondary outcome.	25.0% 1/4 • From the time of enrollment to PD or up to 12 months According to NCI CTCAE 5.0. Seizures were not considered adverse events per protocol as they were defined as a secondary outcome.
Nervous system disorders Paresthesia	12.5% 1/8 • From the time of enrollment to PD or up to 12 months According to NCI CTCAE 5.0. Seizures were not considered adverse events per protocol as they were defined as a secondary outcome.	0.00% 0/4 • From the time of enrollment to PD or up to 12 months According to NCI CTCAE 5.0. Seizures were not considered adverse events per protocol as they were defined as a secondary outcome.
Skin and subcutaneous tissue disorders Rash maculo-papular	12.5% 1/8 • From the time of enrollment to PD or up to 12 months According to NCI CTCAE 5.0. Seizures were not considered adverse events per protocol as they were defined as a secondary outcome.	0.00% 0/4 • From the time of enrollment to PD or up to 12 months According to NCI CTCAE 5.0. Seizures were not considered adverse events per protocol as they were defined as a secondary outcome.
Nervous system disorders Seizure	12.5% 1/8 • From the time of enrollment to PD or up to 12 months According to NCI CTCAE 5.0. Seizures were not considered adverse events per protocol as they were defined as a secondary outcome.	0.00% 0/4 • From the time of enrollment to PD or up to 12 months According to NCI CTCAE 5.0. Seizures were not considered adverse events per protocol as they were defined as a secondary outcome.
Psychiatric disorders Suicidal ideation	0.00% 0/8 • From the time of enrollment to PD or up to 12 months According to NCI CTCAE 5.0. Seizures were not considered adverse events per protocol as they were defined as a secondary outcome.	25.0% 1/4 • From the time of enrollment to PD or up to 12 months According to NCI CTCAE 5.0. Seizures were not considered adverse events per protocol as they were defined as a secondary outcome.
Gastrointestinal disorders Vomiting	12.5% 1/8 • From the time of enrollment to PD or up to 12 months According to NCI CTCAE 5.0. Seizures were not considered adverse events per protocol as they were defined as a secondary outcome.	0.00% 0/4 • From the time of enrollment to PD or up to 12 months According to NCI CTCAE 5.0. Seizures were not considered adverse events per protocol as they were defined as a secondary outcome.