Peranpanel and Levetiracetam vs Levetiracetam doze up Phase 2 study for brain tumor related epilepsy (Phase 2, PPAP study)

Peranpanel and Levetiracetam vs Levetiracetam doze up Phase 2 study for brain tumor related epilepsy (Phase 2, PPAP study) - Peranpanel and Levetiracetam vs Levetiracetam doze up Phase 2 study for brain tumor related epilepsy (Phase 2, PPAP study)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000029585

Enrollment

Registered

2017-10-17

Start date

2017-11-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

brain tumor related epilepsy, high grade glioma

Interventions

A: 1, Initial therapy LEV (1000mg/body) is administrated al least 1W. 2, Doze up therapy PER 2 mg/day is administrated, dose up each 2mg/day every 2 weeks, and dose up to 12mg/day max. 3, Mainte

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)The patient who can report adverse events. 2)Aged 16 to 84 years old 3)Karanofsky performance score(KPS) over 50% 4)Oral medicine is available except for just after operation 5)No concern about chemo-radiotherapy 6)Written informed consent 7)No tumor recognized in the optic ner ve, olfactory nerve and pituitary gland on preoperative 14days MRI. 8)No multiple legions or dissemination recognized on preoperative 14days MRI 9)No tumor recognized in the optic ner ve, olfactory nerve and pituitary gland on preoperative 14days MRI. 10)Planning target volume (irradiated 60 Gy) is less than 2/3 of the brain volume. 11)No prior chemotherapy or radiation therapy for any malignant diseases. 12)Sufficient organ functions

Exclusion criteria

Exclusion criteria: 1) Simultaneous or metachronous (within the past 5 years) double cancers, with the exception of intramucosal tumor curable with local therapy 2) Infection with systemic therapy indicated 3) fever over 38 degrees Celsius 4) Active infectious meningitis 5) Women during pregnancy, possible pregnancy or breast-feeding 6) Psychosis 7) Uncontrollable diabetes mellitus or administration of insulin 8) Unstable angina within 3 weeks, or with a history of myocardial infarction within 6 months 9) Interstitial pneumonia, or fibroid lung 10) Patients who can't receive gadolinium

Design outcomes

Primary

Measure	Time frame
epilepsy disappearance rate	—

Secondary

Measure	Time frame
dates of first epilepsy attack since onset, dates of study end, progression free survival time: PFS, overall survival: OS, adverse events	—

Countries

Japan

Contacts

Public ContactKenichiro Asano

Hirosaki University Graduate School of Medicine Department of Neurosurgery

asanoken@hirosaki-u.ac.jp0172-39-5115

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026