UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026221
Receipt No. R000030122
Scientific Title Safety of perampanel in patients with motor neuron disease
Date of disclosure of the study information 2017/03/01
Last modified on 2019/03/01

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Safety of perampanel in patients with motor neuron disease
Acronym Safety of perampanel in patients with motor neuron disease
Scientific Title Safety of perampanel in patients with motor neuron disease
Scientific Title:Acronym Safety of perampanel in patients with motor neuron disease
Region
Japan

Condition
Condition amyotrophic lateral sclerosis
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate safety in patients with amyotrophic lateral sclerosis
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes Persistency rate of perampanel at week 48
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Once daily perampanel with dose escalation from 2mg to 8mg.
Interventions/Control_2
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 1. Patients (male or female) who are aged over 20 years old.
2. Patients who are diagnosed as definite or probalble (including "laboratory supported-") ALS based on the revised El Escorial diagnostic criteria or the Awaji criteria.
3. Patients who are able to submit written informed consent.
Key exclusion criteria 1. Patients who are expected to show rapid symptomatic progression.
2. Patients with severe complications.
3. Patients with malignancy.
4. Patients with severe psychiatric symptoms.
5. Patients who participated in another cliniccal trial within 12 weeks.
6. Patients who are judged to be ineligible for study entry by the investigators.
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kanai Kazuaki
Organization Juntendo University School of Medicine
Division name Department of Neurology
Zip code
Address 2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL 03-3813-3111
Email kzkanai@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kanai Kazuaki
Organization Juntendo University School of Medicine
Division name Department of Neurology
Zip code
Address 2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL 03-3813-3111
Homepage URL
Email kzkanai@juntendo.ac.jp

Sponsor
Institute Department of Neurology, Juntendo University School of Medicine
Institute
Department

Funding Source
Organization Department of Neurology, 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

Other administrative information
Date of disclosure of the study information
2017 Year 03 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 Completed
Date of protocol fixation
2016 Year 11 Month 11 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 02 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 02 Month 20 Day
Last modified on
2019 Year 03 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030122

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.