UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029585 |
|---|---|
| Receipt number | 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 19:35:59 |
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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
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/
asanoken@hirosaki-u.ac.jp
Sponsor or person
Institute
Department of Neurosurgery, Hirosaki University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033787
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