Clinical Trial Details
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[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02363933 : Perampanel in Seizure Patients With Primary Glial Brain Tumors
PhasePhase 4
AgesMin: 18 Years Max: N/A
Eligibility
Inclusion Criteria:

1. Patients must be diagnosed with a primary glioma and have refractory partial onset
seizure activity (defined as 3 or more seizures in a 28-day period) on levetiracetam
monotherapy

2. Adult patients (? 18 years old)

3. Karnofsky ? 70%

4. Hematocrit ? 29%, ANC ? 1,500 cells/L, platelets ? 100,000 cells/L

5. Serum creatinine ? 1.5 mg/dL, serum AST and bilirubin ? 1.5 times the upper limit of
normal

6. If sexually active, patients will take contraceptive measures for the duration of
protocol treatment and continue until two months after treatment. The effectiveness
of hormonal contraceptives containing levonorgestrel has been shown to be reduced by
perampanel at a 12 mg dose.1 Therefore, alternative or back-up methods of
contraception are recommended.

7. Signed informed consent approved by the Duke Institutional Review Board

Exclusion Criteria:

1. Pregnant or breastfeeding (Both perampanel and other Anti-epileptic drugs are
classified as Pregnancy Category C drugs.)

2. Chronic excessive use of psycho-pharmaceuticals, alcohol, illicit drugs, or narcotics

3. Inability to complete or perform measures of patient-reported outcomes or
neurocognitive testing on the computer

4. Known allergy to perampanel

5. Concomitant use of known cytochrome P450 inducers such as carbamazepine, phenytoin,
or oxcarbazepine (see Appendix A)

6. Previous history of suicidal ideation, homicidal ideation, depression leading to
hospitalization or mood disturbance leading to hospitalization.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02363933      |      Link to official Clinicaltrials.gov listing
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