Trial · NCT04497142

Effect of Perampanel on Peritumoral Hyperexcitability in HGG

NCT04497142, Phase 1, Phase 2, Completed, Dana-Farber Cancer Institute; results first posted 2024-08-05

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Effect of Perampanel on Peritumoral Hyperexcitability in HGG. Trials, record NCT04497142. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04497142

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Effect of Perampanel on Peritumoral Hyperexcitability in HGG
NCT number: NCT04497142
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 12 participants, actual
Lead sponsor: Dana-Farber Cancer Institute
Conditions: Glioma, Malignant, Surgery, Seizures
Interventions: Perampanel, Standard of Care
First posted: 2020-08-04
Last updated: 2024-08-05
Results first posted: 2024-08-05
Limitations and caveats: Early termination after planned interim analysis for futility. 1 participant (perampanel arm) was excluded from outcome analysis after pathology revealed a non-glial tumor, but was included in safety assessment.

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Peritumoral HFO Rate	Peri-operative	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.
Secondary	Seizure-freedom	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.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Peritumoral HFO Rate	Peri-operative	1 participant (perampanel arm) was excluded from analysis after pathology revealed a non-glial tumor	HFOs per minute	MEAN
SECONDARY	Seizure-freedom	From time of initial surgery to PD or up to 12 months		Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Peritumoral HFO Rate	Perampanel + Electrocorticography	2.5	Full Range 0 to 5.6	HFOs per minute
Peritumoral HFO Rate	Standard of Care + Electrocorticography	1.4	Full Range 0.4 to 3.0	HFOs per minute
Seizure-freedom	Perampanel + Electrocorticography	1		Participants
Seizure-freedom	Standard of Care + Electrocorticography	2		Participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Perampanel + Electrocorticography	8
Overall Study	STARTED	Standard of Care + Electrocorticography	4
Overall Study	COMPLETED	Perampanel + Electrocorticography	7
Overall Study	COMPLETED	Standard of Care + Electrocorticography	4
Overall Study	NOT COMPLETED	Perampanel + Electrocorticography	1
Overall Study	NOT COMPLETED	Standard of Care + Electrocorticography	0

Source ClinicalTrials.gov

Adverse events38

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Agitation	Psychiatric disorders	Perampanel + Electrocorticography	1	8
other	Agitation	Psychiatric disorders	Standard of Care + Electrocorticography	0	4
other	Anxiety	Psychiatric disorders	Perampanel + Electrocorticography	1	8
other	Anxiety	Psychiatric disorders	Standard of Care + Electrocorticography	1	4
other	Cognitive disturbance	Nervous system disorders	Perampanel + Electrocorticography	1	8
other	Cognitive disturbance	Nervous system disorders	Standard of Care + Electrocorticography	0	4
other	Concentration impairment	Nervous system disorders	Perampanel + Electrocorticography	2	8
other	Concentration impairment	Nervous system disorders	Standard of Care + Electrocorticography	0	4
other	Constipation	Gastrointestinal disorders	Perampanel + Electrocorticography	1	8
other	Constipation	Gastrointestinal disorders	Standard of Care + Electrocorticography	0	4

1 to 10 of 38Source ClinicalTrials.gov

See all 38 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Perampanel + Electrocorticography	0	8
Total, all-cause mortality	Standard of Care + Electrocorticography	0	4
Total, other adverse events	Perampanel + Electrocorticography	7	8
Total, other adverse events	Standard of Care + Electrocorticography	4	4
Total, serious adverse events	Perampanel + Electrocorticography	0	8
Total, serious adverse events	Standard of Care + Electrocorticography	0	4

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
39499201	DERIVED

Source PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
P50CA165962	Targeted Therapies for Glioma	BATCHELOR, TRACY T	BRIGHAM AND WOMEN'S HOSPITAL	NATIONAL CANCER INSTITUTE	2013 to 2025

Source NIH RePORTER

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Perampanel + Electrocorticography vs Standard of Care + Electrocorticography: Seizure-freedom	Trial comparisons
Perampanel + Electrocorticography vs Standard of Care + Electrocorticography: deaths from any cause	Trial comparisons
Perampanel + Electrocorticography vs Standard of Care + Electrocorticography: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04497142

GET https://conductscience.org/api/trials/v1/NCT04497142/events?page=2

API reference For AI assistants