NCT02363933

Perampanel in Seizure Patients With Primary Glial Brain Tumors

Completed Phase 4 Results posted Last updated 27 April 2018

What this trial tests

Phase 4 trial testing Perampanel in Brain Tumor, Primary in 9 participants. Completed in 10 April 2017.

Timeline

7 April 2015

Primary endpoint
14 March 2017

10 April 2017

Quick facts

Lead sponsor	Duke University
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	9
Start date	7 April 2015
Primary completion	14 March 2017
Estimated completion	10 April 2017
Sites	1 location across United States

Drugs / interventions tested

• Perampanel (PERAMPANEL) — full drug profile →

Conditions studied

• Brain Tumor, Primary — all drugs for Brain Tumor, Primary →

Sponsor

Duke University

Who can join

18 and older, any sex, with Brain Tumor, Primary. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Patients Who Experience a Adverse Event Possibly, Probably, or Definitely Attributable to Perampanel Treatment Secondary · 24 Weeks

The percentage of patients with unacceptable adverse events that are possibly, probably, or definitely related to perampanel treatment will be calculated. Unacceptable adverse events include all Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 Grade 4 or 5 toxicities that are possibly, probably, or definitely related to perampanel, as well as suicidal ideation (any grade) or suicide attempt (Grade 3-5).

Group	Value	95% CI
Perampanel + Current Anti-Epileptic Drug	0

Adverse events — posted to ClinicalTrials.gov

Time frame: 24 Weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Perampanel + Current Anti-Epileptic Drug

Serious: 1/8 (13%)

Deaths: 1/8

Serious adverse events (5 terms)

Reaction	System	Perampanel + Current Anti-…
Multi-organ failure	General disorders	—
Lung infection	Infections and infestations	—
Fall	Injury, poisoning and procedural complications	—
Hypoxia	Respiratory, thoracic and mediastinal disorders	—
Respiratory failure	Respiratory, thoracic and mediastinal disorders	—

Other adverse events (49 terms — click to expand)

Reaction	System	Perampanel + Current Anti-…
Fatigue	General disorders	—
Platelet count decreased	Investigations	—
Hyperglycemia	Metabolism and nutrition disorders	—
Nausea	Gastrointestinal disorders	—
Mucosal infection	Infections and infestations	—
Creatinine increased	Investigations	—
Hypokalemia	Metabolism and nutrition disorders	—
Dizziness	Nervous system disorders	—
Nervous system disorders - Other, specify	Nervous system disorders	—
Pyramidal tract syndrome	Nervous system disorders	—
Confusion	Psychiatric disorders	—
Ear and labyrinth disorders - Other, specify	Ear and labyrinth disorders	—
Eye disorders - Other, specify	Eye disorders	—
Constipation	Gastrointestinal disorders	—
Diarrhea	Gastrointestinal disorders	—
Dysphagia	Gastrointestinal disorders	—
Gastrointestinal disorders - Other, specify	Gastrointestinal disorders	—
Hemorrhoids	Gastrointestinal disorders	—
Vomiting	Gastrointestinal disorders	—
Sinusitis	Infections and infestations	—
Upper respiratory infection	Infections and infestations	—
Urinary tract infection	Infections and infestations	—
Injury, poisoning and procedural complications - Other, specify	Injury, poisoning and procedural complications	—
Alanine aminotransferase increased	Investigations	—
Anemia	Investigations	—
Anmia	Investigations	—
Neutrophil count decreased	Investigations	—
Dehydration	Metabolism and nutrition disorders	—
Hyperkalemia	Metabolism and nutrition disorders	—
Hypermagnesemia	Metabolism and nutrition disorders	—
Hypocalcemia	Metabolism and nutrition disorders	—
Hyponatremia	Metabolism and nutrition disorders	—
Musculoskeletal and connective tissue disorder - Other, specify	Musculoskeletal and connective tissue disorders	—
Myalgia	Musculoskeletal and connective tissue disorders	—
Dysphasia	Nervous system disorders	—
Facial nerve disorder	Nervous system disorders	—
Headache	Nervous system disorders	—
Memory impairment	Nervous system disorders	—
Seizure	Nervous system disorders	—
Somnolence	Nervous system disorders	—

Most-reported serious reactions: Multi-organ failure, Lung infection, Fall, Hypoxia, Respiratory failure.

Data from ClinicalTrials.gov NCT02363933 adverse events section.

Sponsor's own description

This is a Phase 2 single-arm study to assess the efficacy of perampanel as an adjunctive anti-epileptic drug (AED) in patients with primary glioma that are presenting refractory partial onset seizure activity (defined as 3 or more seizures in a 28-day period). In this study, patients will be started on a dose of 2 mg of perampanel daily taken orally at bedtime for 2 weeks. At the start of week 3 perampanel will be titrated up in dose in 2mg increments per week up to 8mg daily, as long as it is well tolerated by the patient. The highest dose of perampanel will be 8 mg orally at bedtime. Once this is achieved, patients will remain on a maintenance dose of 8 mg for 12 more weeks. The planned treatment dose is 8mg, but the dose can be modified by the physician based on patient reported tolerability. Titration and taper periods will be determined by the physician in the case where patients do not reach the planned treatment dose of 8 mg daily. Patients will be assessed in the Brain Tumor Center Clinic every 8 weeks. Study assessments will be made at enrollment, 8 weeks, 16 weeks, and 24 weeks. Assessments will include history and physical examination (H\&P) including Karnofsky Performance Status (KPS), neurological examination, evaluation of seizure history, patient-reported outcomes of QoL, and computer based neurocognitive testing. After a total of 16 weeks of therapy, perampanel will be tapered down. At Week 17, patients will begin taking 6mg of perampanel, Week 18 4mg, Week 19 2mg, and Week 20 they will no longer take perampanel. Patients will be considered off treatment at the end of week 20, once perampanel has cleared their system. Patients will then be monitored through Week 24. Patients will continue to take their original AED regimen after they stop perampanel. If seizure control is achieved during the maintenance period or if seizures occur during the tapering period, patients can be continued on perampanel per the discretion of the treating physician. In this instance, perampanel will be prescribed by the treating physician and not provided within the confines of the study. Efficacy will be assessed using a log of patient-reported seizure activity. As is standard procedure at the Preston Robert Tisch Brain Tumor Center (PRTBTC), patients will be given a log to record the number of seizures that occur. Research team members will regularly contact patients for reminders and reports from the log. Safety will be assessed with the following laboratory evaluations: complete blood count (CBC) with differential, complete metabolic panel (CMP), and toxicity assessment.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Adjunctive perampanel for glioma-associated epilepsy.
   Dunn-Pirio AM, Woodring S, Lipp E, Herndon JE, et al · · 2018 · cited 27× · PMID 30377587 · DOI 10.1016/j.ebcr.2018.09.003
2. Hijacking of the nervous system in cancer: mechanism and therapeutic targets.
   Zhang Y, Liao Q, Wen X, Fan J, et al · · 2025 · cited 20× · PMID 39915765 · DOI 10.1186/s12943-025-02246-5
3. Neuron-Glial Interactions in Health and Brain Cancer.
   Pan Y, Monje M. · · 2022 · cited 20× · PMID 35957525 · DOI 10.1002/adbi.202200122
4. Efficacy and Tolerability of Perampanel in Brain Tumor-Related Epilepsy: A Systematic Review.
   Rossi J, Cavallieri F, Bassi MC, Biagini G, et al · · 2023 · cited 16× · PMID 36979629 · DOI 10.3390/biomedicines11030651
5. Ligand-Gated Ion Channels: Prognostic and Therapeutic Implications for Gliomas.
   Hey G, Rao R, Carter A, Reddy A, et al · · 2023 · cited 9× · PMID 37241023 · DOI 10.3390/jpm13050853