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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047630


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name