UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029588 |
|---|---|
| Receipt number | R000033804 |
| Scientific Title | Treatment of amyotrophic lateral sclerosis with high-dose methylcobalamin: phase III clinical trial |
| Date of disclosure of the study information | 2017/10/19 |
| Last modified on | 2024/04/23 12:49:32 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Treatment of amyotrophic lateral sclerosis with high-dose methylcobalamin: phase III clinical trial
Acronym
Japan Early-stage Trial of high-dose methylcobalamin for ALS (JETALS)
Scientific Title
Treatment of amyotrophic lateral sclerosis with high-dose methylcobalamin: phase III clinical trial
Scientific Title:Acronym
Japan Early-stage Trial of high-dose methylcobalamin for ALS (JETALS)
Region
| Japan |
Condition
Condition
Amyotrophic lateral sclerosis
Classification by specialty
| Endocrinology and Metabolism | Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the efficacy of high-dose methylcobalamin compared with placebo in patients with Amyotrophic Lateral Sclerosis (ALS) by assessing changes in scores of ALSFRS-R score. And to investigate the safety.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change from baseline in ALSFRS-R scores at 16 weeks
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intramuscular injection, mechylcobalamin 50 mg twice a week for 16 weeks.
Interventions/Control_2
Intramuscular injection, placebo twice a week for 16 weeks.
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
*Definite, probable or probable-laboratory supported in the Updated Awaji criteria.
*Within 1-year elapsed time period from disease onset at the start of observation period.
*Total ALSFRS-R score was lowered by 1-2 points during the observation period (12 weeks).
*Stage 1 or 2 of the severity criteria for ALS.
*Able to visit study site for out-patient treatment.
Key exclusion criteria
*Tracheostomy.
*Experienced non-invasive positive pressure ventilation.
*%FVC >= 60%.
*Chronic obstructive pulmonary disease.
*Edaravone use within 4weeks before starting the observation period.
*Initiated newly introduced riluzole therapy after starting the observation period. Or received dose escalation or resumed administration of riluzole therapy after previous down titration or discontinuation.
*Cognitive impairment.
*Participated in another clinical study within 12 weeks before starting the observation period.
Target sample size
128
Research contact person
Name of lead principal investigator
| 1st name | Yuishin |
| Middle name | |
| Last name | Izumi |
Organization
Tokushima University Hospital
Division name
Neurology
Zip code
770-8503
Address
Kuramoto-cho 2-50-1, Tokushima
TEL
088-633-9658
chousei763@umin.ac.jp
Public contact
Name of contact person
| 1st name | Yuishin |
| Middle name | |
| Last name | Izumi |
Organization
Tokushima University Hospital
Division name
Office of coordinating investigator
Zip code
770-8503
Address
Kuramoto-cho 2-50-1, Tokushima 770-8503
TEL
088-633-9658
Homepage URL
http://neuro-tokushima.com/
chousei763@umin.ac.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
Funding Source
Organization
AMED
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
Tokushima University Hospital
Address
Kuramoto-cho 2-50-1, Tokushima
Tel
088-633-9658
chousei763@umin.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
| 2017 | Year | 10 | Month | 19 | 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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 08 | Month | 25 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 31 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 07 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 17 | 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=R000033804
