A Study to Evaluate an Adjunctive Anti-Seizure Medication to Treat Patients with Drug-Resistant Focal Epilepsy and High-Grade Glioma

Overview

About this study

 

The purpose of this study is to evaluate the effectiveness of Perampanel on seizure frequency in adult patients with brain-tumor with and without seizures associated with glioma.

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • The subject, or the subject’s legally acceptable representative, is willing to participate in a clinical trial, provides written informed consent, and subject provides written assent, as required by the Mayo Clinic Institutional Review Board (IRB) policy involving human subjects.
  • Subjects that satisfy the following diagnostic criteria:
    • Patients with established clinical diagnoses, of high-grade glioma (WHO class III and IV) and epilepsy refractory to at least one ASD, with a seizure frequency of at least 1 seizure per month during baseline;
    • Subjects with body weight of  ≥ 40 kg and ≤ 125 kg at screening;
    • Adults ages 18 and older.

Exclusion Criteria:

  • Subject has serious cardiac, respiratory, renal, gastrointestinal, hematologic or other medical condition as determined by the investigator to potentially interfere with the study.
  • Subjects with high-grade glioma not following Stupp protocol for treatment of glioblastoma.
  • History of status epilepticus in the 6 months prior to screening or a history of seizure clusters progressing to status epilepticus.
  • Clinically significant suicide risk as determined by the clinician.
  • Positive test result for drugs of abuse at baseline without documented history of stable use for medical purposes or past medical history of drug and/or alcohol abuse.
  • Pregnant or breast-feeding.
  • Subjects treated with PER prior to baseline.
  • Prior felony conviction disclosed by the patient or previously stated in medical record.
  • History of violent behavior.
  • Clinically significant laboratory abnormality at screening or baseline visits, as determined by the investigators.
  • Use of an investigational drug or device within 20 days prior to treatment Day 1.
  • Repeated radiation therapy for tumor regrowth
  • Subjects that plan to undergo tumor resection on or after baseline visit.
  • Uncontrolled psychiatric disorder at baseline
  • Subjects who report active suicidal attempts or suicidality including subjects with a history of suicide attempts or suicidality determined to be clinically significant by investigators at screening.
  • Biopsy proven high-grade glioma (WHO III and IV) with seizures established 3 months prior to enrollment.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

William Tatum, D.O.

Open for enrollment

Contact information:

Amber Baskin CCRP

(904)953-9675

Baskin.Amber@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20478652

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