UMIN-CTR Clinical Trial

Basic information
Public title	Multiple neurophysiologic biomarkers evaluated the pulmonary function of ALS.
Acronym	Multiple neurophysiologic biomarkers evaluated the pulmonary function of ALS.
Scientific Title	Multiple neurophysiologic biomarkers evaluated the pulmonary function of ALS.
Scientific Title:Acronym	Multiple neurophysiologic biomarkers evaluated the pulmonary function of ALS.
Region	Japan

Condition
Condition	amyotrophic lateral sclerosis(ALS)
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	For evaluating the pulmonary function of ALS, new neurophysiological evaluations, which performed using phrenic nerve conduction study (PNCS), diaphragm ultrasonography (DUS) and new measurement system of thoracic excursion are proposed as novel biomarkers.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase

Assessment
Primary outcomes	The relationships between neurophysiological biomarkers (amplitude of diaphragmatic compound muscle action potential, diaphragm thickness measured by ultrasonography, thoracic excursion),%FVC of respiratory function test, PaCO2 of blood gas analysis.
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	90 years-old >
Gender	Male and Female
Key inclusion criteria	Patients diagnosed with definite, or probable and possible ALS based on the modified El Escorial criteria.
Key exclusion criteria	1.Patients who received unapproved drugs in Japan for ALS or underwent surgery within 12 months (48 weeks) before informed consent 2.Patients with dimentia(MMSE<10) 3.Patients with severe phychiatric disorder 4.Patients who are not able to answer questionnaires 5.Patients with suicidal ideation 6.Patients undergoing treatment for respiratory disease 7.Patients with severe heart failure 8.Patients with pregnancy 9.Patients judged to be inappropriate for this study by the investigator or coordinator
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Naohiko Middle name Last name Iguchi
Organization	Nara Medical University
Division name	Department of Neurology
Zip code	634-8522
Address	840, Shizyo-cho, Kashihara-City, Nara, Japan
TEL	0744223051
Email	naohiko-iguchi@naramed-u.ac.jp

Public contact
Name of contact person	1st name Naohiko Middle name Last name Iguchi
Organization	Nara Medical University
Division name	Department of Neurology
Zip code	634-8522
Address	840, Shizyo-cho, Kashihara-City, Nara, Japan
TEL	0744223051
Homepage URL
Email	naohiko-iguchi@naramed-u.ac.jp

Sponsor
Institute	Nara Medical University
Institute
Department

Funding Source
Organization	Nara Medical University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nara Medical University
Address	840, Shizyo-cho, Kashihara-City, Nara, Japan
Tel	0744223051
Email	naohiko-iguchi@naramed-u.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

Other administrative information
Date of disclosure of the study information	2020 Year 10 Month 23 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 06 Month 01 Day
Date of IRB
Anticipated trial start date	2020 Year 10 Month 23 Day
Last follow-up date	2022 Year 10 Month 23 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	None

Management information
Registered date	2020 Year 10 Month 23 Day
Last modified on	2021 Year 11 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048204