UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025614 |
|---|---|
| Receipt number | R000029464 |
| Scientific Title | Perampanel for sporadic amyotrophic lateral sclerosis (ALS): A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 2 Trial |
| Date of disclosure of the study information | 2017/02/01 |
| Last modified on | 2021/01/14 15:26:16 |
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Basic information
Public title
Perampanel for sporadic amyotrophic lateral sclerosis (ALS): A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 2 Trial
Acronym
Perampanel for sporadic amyotrophic lateral sclerosis (ALS)
Scientific Title
Perampanel for sporadic amyotrophic lateral sclerosis (ALS): A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 2 Trial
Scientific Title:Acronym
Perampanel for sporadic amyotrophic lateral sclerosis (ALS)
Region
| Japan |
Condition
Condition
Sporadic amyotrophic lateral sclerosis
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the safety and the efficacy of perampanel in patients with sporadic amyotrophic lateral sclerosis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
To evaluate the effect of perampanel on progression of the disease in subjects with ALS, as measured by the ALS Functional Rating Scale -Revised (ALSFRS-R). [Time Frame: 48 weeks.] [Designated as safety issue: Yes]
Key secondary outcomes
Change in ALSFRS-R slope [Time Frame: Every 12 weeks.] [Designated as safety issue: Yes]
Manual Muscle Test (MMT) [Time Frame: Every 12 weeks.] [Designated as safety issue: Yes]
Percent-predicted forced vital capacity (%FVC) [Time Frame: Every 12 weeks.] [Designated as safety issue: Yes]
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Once daily perampanel with dose-escalation tolerable from 2mg to 4mg for 48 weeks (Interventions)
Interventions/Control_2
Once daily perampanel with dose-escalation tolerable from 2mg to 8mg for 48 weeks (Interventions).
Interventions/Control_3
Once daily placebo for 48 weeks (Control)
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
| 40 | years-old | <= |
Age-upper limit
| 78 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
[Interim Registration]
- Patients who are able to submit written informed consent. If patients are duly capable of study consent but are unable to sign by themselves due to aggravation of disease condition, written informed consent can be obtained from a legally authorized representative who can sign on behalf of the patients after confirming the patients' agreement to study participation.
- Patients who are male or female aged 40 years to 78 years at the time of obtaining informed consent
- Patients who have clinically definite ALS, clinically probable ALS, or clinically probable-laboratory supported ALS as specified in the revised El Escorial Airlie House diagnostic criteria.
- The sum of the 3 respiratory items of the ALSFRS-R must total 12 points or more
- Patients within 2-year elapsed time period from disease onset at the time of obtaining informed consent
- Patients who can visit study site for out-patient treatment
[Registration]
Subjects who meet the following criteria in addition to the inclusion criteria for the interim registration
- The progression on score of ALSFRS-R during 3 months of observation period must be between -2 and -5
- Patients who has not initiated newly introduced riluzole therapy after starting the observation period. Or those who has not received dose escalation or resumed administration of riluzole therapy after previous down titration or discontinuation
- Patients who has not initiated newly introduced edaravone therapy after starting the observation period
- Patients who are judged to be eligible for continuation of the study by the investigators
Key exclusion criteria
- Patients who underwent tracheostomy.
- Patients who experienced non-invasive positive pressure ventilation.
- Patients whose percent-predicted forced vital capacity (%FVC) is <80%.
- Patients with progressive bulbar palsy type.
- Patients with cognitive impairment, severe disease in the renal, cardiovascular, or hematological system.
- Patients with hepatic disease.
- Patients with malignant tumor.
- Pregnant women or women with a possibility of becoming pregnant.
- Patients who participated in another clinical study within 12 weeks before starting the observation period.
- Patients who has initiated perampanel therapy in the past or at present.
- Patients who are judged to be ineligible for study entry by the investigators.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Aizawa |
Organization
Tokyo Medical University Hospital
Division name
Department of Neurology
Zip code
160-0023
Address
Nishishinjuku 6-7-1, Shinjuku-ku, Tokyo, 160-0023, Japan
TEL
03-3342-6111
haizawa@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Haruhisa |
| Middle name | |
| Last name | Kato |
Organization
Tokyo Medical University Hospital
Division name
Department of Neurology
Zip code
160-0023
Address
Nishishinjuku 6-7-1, Shinjuku-ku, Tokyo, 160-0023, Japan
TEL
03-3342-6111
Homepage URL
h-kato@tokyo-med.ac.jp
Sponsor or person
Institute
Department of Neurology, Tokyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Medical Association
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Perampanel was given by Eizai.Co.
IRB Contact (For public release)
Organization
Tokyo Medical University Hospital
Address
Nishishinjuku 6-7-1, Shinjuku-ku, Tokyo, 160-0023, Japan
Tel
03-3342-6111
yuki-m@tokyo-med.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
NCT03019419
Org. issuing International ID_1
ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東京医科大学病院（東京都）Tokyo Medical University Hospital (Tokyo)
筑波大学附属病院（茨城県）University of Tsukuba Hospital (Ibaraki)
北里大学東病院（神奈川県）Kitasato University East Hospital (Kanagawa)
岡山大学病院（岡山県）Okayama University Hospital (Okayama)
北海道大学病院（北海道）Hokkaido University Hospital (Hokkaido)
東京都立神経病院（東京都）Tokyo Metropolitan Neurological Hospital (Tokyo)
滋賀医科大学医学部附属病院（滋賀県）Shiga University of Medical Science Hospital (Shiga)
東北大学病院（宮城県）Tohoku University Hospital (Miyagi)
山口大学医学部附属病院（山口県）Yamaguchi University Hospital (Yamaguchi)
名古屋大学医学部附属病院（愛知県）Nagoya University Hospital (Aichi)
独立行政法人国立病院機構熊本再春荘病院（熊本県）Kumamoto Saishunso National Hospital (Kumamoto)
東京大学医学部附属病院（東京都）The University of Tokyo Hospital
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | 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
66
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
| 2017 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 10 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 24 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 23 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 23 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 23 | Day |
Date analysis concluded
| 2021 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 11 | Day |
Last modified on
| 2021 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029464
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