UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026221 |
|---|---|
| Receipt number | 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 12:12:18 |
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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
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
kzkanai@juntendo.ac.jp
Sponsor or person
Institute
Department of Neurology, Juntendo University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030122
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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