UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025026
Receipt number R000028801
Scientific Title Cognitive effects of adjunctive perampanel in patients with refractory epilepsy: an open-label, comparative study
Date of disclosure of the study information 2016/12/01
Last modified on 2020/03/01 10:43:54

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Basic information

Public title

Cognitive effects of adjunctive perampanel in patients with refractory epilepsy: an open-label, comparative study

Acronym

Cognitive effects of perampanel

Scientific Title

Cognitive effects of adjunctive perampanel in patients with refractory epilepsy: an open-label, comparative study

Scientific Title:Acronym

Cognitive effects of perampanel

Region

Japan


Condition

Condition

Epilepsy

Classification by specialty

Neurology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate cognitive effects of adjunctive perampanel in patients with refractory epilepsy

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Changes of cognitive assessment scores from baseline after 48 weeks

Key secondary outcomes

Seizure frequency
Adverse events


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Patients are treated with perampanel for 48 weeks.

Interventions/Control_2

Patients are treated with other antiepileptic drugs for 48 weeks.

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients had at least one partial seizure during the previous 3 months, despite a stable regimen of 1 or more antiepileptic drugs.

Key exclusion criteria

1. Pregnant or breast feeding
2. Simple partial seizure without motor symptoms
3. Primary generalized epilepsy
4. Psychiatric disorders
5. Unstable coronary heart disease
6. Drug and alcohol abuse
7. Surgical indication
8. Difficult to make decisions about participation due to severe cognitive impairment

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuo Yamashiro

Organization

Juntendo University School of Medicine

Division name

Department of Neurology

Zip code


Address

2-1-1 Hongo, Bukyo-ku, Tokyo

TEL

03-3813-3111

Email

kazuo-y@juntendo.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kazuo Yamashiro

Organization

Juntendo University School of Medicine

Division name

Department of Neurology

Zip code


Address

2-1-1 Hongo, Bukyo-ku, Tokyo

TEL

03-3813-3111

Homepage URL


Email

kazuo-y@juntendo.ac.jp


Sponsor or person

Institute

Department of Neurology, Neurosurgery, Juntendo University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Neurology, Neurosurgery, Juntendo University School of Medicine

Organization

Division

Category of Funding Organization

Self funding

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

順天堂大学医学部付属順天堂医院(東京都)


Other administrative information

Date of disclosure of the study information

2016 Year 12 Month 01 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

Terminated

Date of protocol fixation

2016 Year 10 Month 18 Day

Date of IRB

2016 Year 10 Month 18 Day

Anticipated trial start date

2017 Year 01 Month 04 Day

Last follow-up date

2018 Year 11 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 11 Month 28 Day

Last modified on

2020 Year 03 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028801


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name