UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Peranpanel and Levetiracetam vs Levetiracetam doze up Phase 2 study for brain tumor related epilepsy (Phase 2, PPAP study)
Title of the study (Brief title)	Peranpanel and Levetiracetam vs Levetiracetam doze up Phase 2 study for brain tumor related epilepsy (Phase 2, PPAP study)
Region	Japan

Condition
Condition	brain tumor related epilepsy, high grade glioma
Classification by specialty	Neurosurgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to evaluate efficacy, safety, and the epilepsy disappearance rate of peranpanel(PER) plus levetilacetam(LEV) with brain tumor related epilepsy of high grade glioma, comparing to only LEV dose up therapy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	epilepsy disappearance rate
Key secondary outcomes	dates of first epilepsy attack since onset, dates of study end, progression free survival time: PFS, overall survival: OS, adverse events

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	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, Maintenance therapy Both drugs are continued until adverse event or not effective status.
Interventions/Control_2	1, Initial therapy LEV (1000mg/body) is administrated al least 1W. 2, Doze up therapy LEV is dose up each 1000mg/body every 2 weeks, and dose up to 3000mg/body max. 3, Maintenance therapy Both drugs are continued until adverse event or not effective status.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	16 years-old <=
Age-upper limit	85 years-old >
Gender	Male and Female
Key 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
Key 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
Target sample size	50

Research contact person
Name of lead principal investigator	Hiroki Ohkuma
Organization	Hirosaki University Graduate School of Medicine
Division name	Department of Neurosurgery
Address	Zaifu-cho 5, Hirosaki-shi, Aomori Prefecture, 036-8562, Japan
TEL	0172-39-5115
Email	ohkuma@hirosaki-u.ac.jp

Public contact
Name of contact person	Kenichiro Asano
Organization	Hirosaki University Graduate School of Medicine
Division name	Department of Neurosurgery
Address	Zaifu-cho 5, Hirosaki-shi, Aomori Prefecture, 036-8562, Japan
TEL	0172-39-5115
Homepage URL	http://www.med.hirosaki-u.ac.jp/~neuros/
Email	asanoken@hirosaki-u.ac.jp

Sponsor
Institute	Department of Neurosurgery, Hirosaki University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of Neurosurgery, Hirosaki University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 10 Month 17 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 10 Month 02 Day
Anticipated trial start date	2017 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 10 Month 16 Day
Last modified on	2017 Year 10 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033787