UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041729 |
|---|---|
| Receipt number | R000047630 |
| Scientific Title | Observational study on clinical course and prognostic factors of amyotrophic lateral sclerosis (ALS) |
| Date of disclosure of the study information | 2020/11/01 |
| Last modified on | 2020/11/07 14:16:10 |
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Basic information
Public title
Observational study on clinical course and prognostic factors of amyotrophic lateral sclerosis (ALS)
Acronym
Observational study for amyotrophic lateral sclerosis (ALS)
Scientific Title
Observational study on clinical course and prognostic factors of amyotrophic lateral sclerosis (ALS)
Scientific Title:Acronym
Observational study for amyotrophic lateral sclerosis (ALS)
Region
| Japan |
Condition
Condition
amyotrophic lateral sclerosis
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To clarify the natural history of amyotrophic lateral sclerosis (ALS) and prognostic factors affecting disease progression
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. ALSFRS-R change rate
2. Period from onset to death or tracheostomy/invasive positive pressure ventilation
3. Period from onset to full-day non-invasive positive pressure ventilation (>22 hours/day)
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Patients who were diagnosed as "possible ALS", "probable ALs laboratory-supported", "probable ALS", or "definite ALS" in the El Escorial diagnostic criteria revised. Otherwise, patients who were diagnosed as "possible ALS", "probable ALs laboratory-supported", "probable ALS", or "definite ALS" in the updated Awaji criteria. Both sporadic and familial ALS patients will be assigned.
Key exclusion criteria
1. Patients who have participated in a clinical trial for ALS and have been administered the investigational drug
2. Patients who have other serious complications and are considered unsuitable for the natural history survey by the investigator
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Warita |
Organization
Tohoku University Hospital
Division name
Department of Neurology
Zip code
980-8574
Address
Seiryo-Cho 1-1, Aoba-ku, Sendai, Miyagi, Japan
TEL
022-717-7189
warita-ns@umin.net
Public contact
Name of contact person
| 1st name | Tomomi |
| Middle name | |
| Last name | Shijo |
Organization
Tohoku University Hospital
Division name
Department of Neurology
Zip code
980-8574
Address
Seiryo-Cho 1-1, Aoba-ku, Sendai, Miyagi, Japan
TEL
022-717-7189
Homepage URL
shijo-t@med.tohoku.ac.jp
Sponsor or person
Institute
Department of Neurology, Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Neurology, Minami Tohoku Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Neurology, Tohoku University Hospital
Address
Seiryo-Cho 1-1, Aoba-ku, Sendai, Miyagi, Japan
Tel
022-717-7189
shijo-t@med.tohoku.ac.jp
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
東北大学病院 (宮城県)
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 11 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 10 | Month | 27 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 16 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 28 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
a
Management information
Registered date
| 2020 | Year | 09 | Month | 08 | Day |
Last modified on
| 2020 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047630
