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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029585
Receipt No. R000033787
Scientific Title Peranpanel and Levetiracetam vs Levetiracetam doze up Phase 2 study for brain tumor related epilepsy (Phase 2, PPAP study)
Date of disclosure of the study information 2017/10/17
Last modified on 2017/10/16

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Basic information
Public title Peranpanel and Levetiracetam vs Levetiracetam doze up Phase 2 study for brain tumor related epilepsy (Phase 2, PPAP study)
Acronym Peranpanel and Levetiracetam vs Levetiracetam doze up Phase 2 study for brain tumor related epilepsy (Phase 2, PPAP study)
Scientific Title Peranpanel and Levetiracetam vs Levetiracetam doze up Phase 2 study for brain tumor related epilepsy (Phase 2, PPAP study)
Scientific Title:Acronym 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
1st name
Middle name
Last name Hiroki Ohkuma
Organization Hirosaki University Graduate School of Medicine
Division name Department of Neurosurgery
Zip code
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
1st name
Middle name
Last name Kenichiro Asano
Organization Hirosaki University Graduate School of Medicine
Division name Department of Neurosurgery
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2017 Year 10 Month 02 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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