UMIN-CTR Clinical Trial

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
Email	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
Email	shijo-t@med.tohoku.ac.jp

Sponsor
Institute	Department of Neurology, Tohoku University Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047630