UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015449 |
|---|---|
| Receipt number | R000017962 |
| Scientific Title | The study of amyotrophic lateral sclerosis biomarker |
| Date of disclosure of the study information | 2014/10/16 |
| Last modified on | 2024/04/23 09:48:49 |
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Basic information
Public title
The study of amyotrophic lateral sclerosis biomarker
Acronym
The study of ALS biomarker
Scientific Title
The study of amyotrophic lateral sclerosis biomarker
Scientific Title:Acronym
The study of ALS biomarker
Region
| Japan |
Condition
Condition
Amyotrophic lateral sclerosis
Parkinson's disease
Multiple sclerosis
Healthy individuals
Classification by specialty
| Neurology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The verification of the usefulness of oxidative stress regulatory factor as the ALS biomarker using blood sample from ALS patients
Basic objectives2
Others
Basic objectives -Others
In order to analyze whether quantitative alteration of oxidative stress regulatory factor is specific in ALS, blood sample from healthy individuals and patients with Parkinson's disease and multiple sclerosis as controls would be also analyzed.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Exploration of novel biomarker
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed as having ALS and satisfying all of the following criteria.
1)ALS patients who are diagnosed by EL Escorial revised Airlie House criteria as clinically definite,clinically probable or clinically probable-laboratory-supported, clinically pssible ALS or clinically suspected ALS, and Stage I, II or III in ALS severity classification.
2)Older than 20 and younger than 70 years old
3)Patients who give informed consent after detailed explanation of the study
As disease controls, PD or MS patients satisfying all of the following criteria.
1)Older than 20 and younger than 75 years old
2)Patients who consulted a nerve outpatient and obtained consent for study entry
3)Patients who give informed consent after detailed explanation of the study
Healthy individuals satisfying all of the following criteria.
1)Older than 20 and younger than 65 years old
2)Healthy individuals who have interest in this study
3)Healthy individuals who give informed consent after detailed explanation of the study
Key exclusion criteria
1)Patient to whom the diagnosis has not been disclosed
2)Patient having severe psychiatric symptoms (hallucination, delusion) or dementia
3)Patient having serious orthostatic hypotension or other types of hypotension
4)Patient having a severe complication(s) such as heart, kidney and/or liver disease
5)Patient having the complications of the allergic disease that an acidophile level is easy to rise
6)Patient did not have ability to comprehend informed consent
7)Patient who was inappropriate for this study
8)Patient who has received an investigational drugs or devices within three months before
9) Patient who participates in other clinical trials
*The patient treated with existing therapeutic drug does not correspond to exclusion criteria
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Osamu |
| Middle name | |
| Last name | Kano |
Organization
Toho University Faculty of Medicine
Division name
Division of Neurology, Department of Internal Medicine
Zip code
143-8541
Address
6-11-1 Omorinishi Ota-ku, Tokyo 143-8541 Japan
TEL
03-3762-4151
osamukano2@gmail.com
Public contact
Name of contact person
| 1st name | Osamu |
| Middle name | |
| Last name | Kano |
Organization
Toho University Faculty of Medicine
Division name
Division of Neurology, Department of Internal Medicine
Zip code
143-8541
Address
6-11-1 Omorinishi Ota-ku, Tokyo 143-8541 Japan
TEL
0337624151
Homepage URL
osamukano2@gmail.com
Sponsor or person
Institute
Toho University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Neurology, Department of Internal Medicine, Toho University Faculty of Medicine
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
Toho University Faculty of Medicine
Address
5-21-16 Omorinishi Ota-ku Tokyo
Tel
03-3762-4151
med.rinri@ext.toho-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
| 2014 | Year | 10 | Month | 16 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/35569927/
Publication of results
Partially published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/35569927/
Number of participants that the trial has enrolled
50
Results
The average time from the start to the end of the 3 courses was 319.7(33.7) days. A multiple regression analysis was performed for the 2-minutes-walk and 10-m-walk tests, using the baseline value, each participant's ID, and time point as covariates.
Results date posted
| 2024 | Year | 04 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Objective To assess the long-term effects of hybrid assistive limb (HAL) treatment on gait in patients with amyotrophic lateral sclerosis (ALS). Methods Three courses of treatment with HAL were administered to three women with ALS. Each course had a four- to five-week duration, during which the treatment was performed nine times, with a rest period of at least two months between each course. Gait ability (2-minutes-walk and 10-m-walk tests), ALS Functional Rating Scale-Revised, and respiratory function tests were performed before and after each treatment course. Patients Patients diagnosed with ALS, according to the updated Awaji criteria, by board-certified neurologists in the Department of Neurology and Department of Rehabilitation Medicine, Toho University Omori Faculty of Medicine between January and December 2019 were recruited.
Participant flow
Objective To assess the long-term effects of hybrid assistive limb (HAL) treatment on gait in patients with amyotrophic lateral sclerosis (ALS). Methods Three courses of treatment with HAL were administered to three women with ALS. Each course had a four- to five-week duration, during which the treatment was performed nine times, with a rest period of at least two months between each course. Gait ability (2-minutes-walk and 10-m-walk tests), ALS Functional Rating Scale-Revised, and respiratory function tests were performed before and after each treatment course. Patients Patients diagnosed with ALS, according to the updated Awaji criteria, by board-certified neurologists in the Department of Neurology and Department of Rehabilitation Medicine, Toho University Omori Faculty of Medicine between January and December 2019 were recruited.
Adverse events
N/A
Outcome measures
Objective To assess the long-term effects of hybrid assistive limb (HAL) treatment on gait in patients with amyotrophic lateral sclerosis (ALS). Methods Three courses of treatment with HAL were administered to three women with ALS. Each course had a four- to five-week duration, during which the treatment was performed nine times, with a rest period of at least two months between each course. Gait ability (2-minutes-walk and 10-m-walk tests), ALS Functional Rating Scale-Revised, and respiratory function tests were performed before and after each treatment course. Patients Patients diagnosed with ALS, according to the updated Awaji criteria, by board-certified neurologists in the Department of Neurology and Department of Rehabilitation Medicine, Toho University Omori Faculty of Medicine between January and December 2019 were recruited.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2013 | Year | 11 | Month | 13 | Day |
Date of IRB
| 2014 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2014 | Year | 10 | Month | 16 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
This is a prospective observational study to establish biomarker for disease progression in ALS. As control groups, healthy individuals, patients with Parkinson's disease would be analyzed.
Management information
Registered date
| 2014 | Year | 10 | Month | 16 | Day |
Last modified on
| 2024 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017962
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