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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000029588
Receipt No. 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 2019/08/01

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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
Middle name
Last name Yuishin Izumi
Organization Tokushima University Hospital
Division name Neurology
Zip code
Address Kuramoto-cho, Tokushima 770-8503
TEL 088-633-9658
Email chousei763@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuishin Izumi
Organization Tokushima University Hospital
Division name Office of coordinating investigator
Zip code
Address Kuramoto-cho, Tokushima 770-8503
TEL 088-633-9658
Homepage URL http://neuro-tokushima.com/
Email chousei763@umin.ac.jp

Sponsor
Institute Tokushima University
Institute
Department

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
Address
Tel
Email

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
2019 Year 08 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033804

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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