UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054897 |
|---|---|
| Receipt number | R000062726 |
| Scientific Title | Ancillary exploratory studies of the randomized, double-blind, placebo-controlled Phase II study to evaluate the efficacy and safety of Tranilast on motor, respiratory, and cardiac function in patients with Duchenne muscular dystrophy aged 10 years and older, urinary titin and metabolome analysis |
| Date of disclosure of the study information | 2024/07/08 |
| Last modified on | 2024/07/05 22:04:53 |
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Basic information
Public title
Ancillary exploratory studies of the randomized, double-blind, placebo-controlled Phase II study to evaluate the efficacy and safety of Tranilast on motor, respiratory, and cardiac function in patients with Duchenne muscular dystrophy aged 10 years and older, urinary titin and metabolome analysis
Acronym
Ancillary exploratory studies of the TRPV2 inhibition therapy, urinary titin and metabolome analysis
Scientific Title
Ancillary exploratory studies of the randomized, double-blind, placebo-controlled Phase II study to evaluate the efficacy and safety of Tranilast on motor, respiratory, and cardiac function in patients with Duchenne muscular dystrophy aged 10 years and older, urinary titin and metabolome analysis
Scientific Title:Acronym
Ancillary exploratory studies of the TRPV2 inhibition therapy, urinary titin and metabolome analysis
Region
| Japan |
Condition
Condition
Duchenne muscular dystrophy
Classification by specialty
| Neurology | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Urine titin and metabolome will be assessed in Tranlilast study participants before, four weeks after, and 52 weeks after treatment to determine if they are biomarkers that can be used to assess the progression of muscular dystrophy, myocardial damage, and treatment response.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Urinary titin, PG metabolites
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
| 10 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
Participants of the randomized, double-blind, placebo-controlled Phase II study to evaluate the efficacy and safety of Tranilast on motor, respiratory, and cardiac function in patients with Duchenne muscular dystrophy aged 10 years and older
Key exclusion criteria
Non participants of the Randomized, double-blind, placebo-controlled Phase II study to evaluate the efficacy and safety of Tranilast on motor, respiratory, and cardiac function in patients with Duchenne muscular dystrophy aged 10 years and older
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Matsumura |
Organization
NHO Osaka Toneyama Medical Center
Division name
Neurology
Zip code
560-8552
Address
5-1-1 Toneyama, Toyonaka, Osaka, Japan
TEL
0668532001
matsumura.tsuyoshi.kq@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Matsumura |
Organization
NHO Osaka Toneyama Medical Center
Division name
Neurology
Zip code
560-8552
Address
5-1-1 Toneyama, Toyonaka, Osaka, Japan
TEL
06-6853-2001
Homepage URL
matsumura.tsuyoshi.kq@mail.hosp.go.jp
Sponsor or person
Institute
NHO Osaka Toneyama Medical Center
Institute
Department
Personal name
Tsuyoshi Matsumura
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Cerebral and Cardiovascular Center, Doshisha Women's College
Name of secondary funder(s)
IRB Contact (For public release)
Organization
NHO Osaka Toneyama Medical Center
Address
5-1-1 Toneyama, Toyonaka, Osaka, Japan
Tel
06-6853-2001
410-chiken@mail.hosp.go.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
| 2024 | Year | 07 | Month | 08 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 05 | Month | 05 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 21 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 08 | Day |
Last follow-up date
| 2028 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Urinary titin and PG metabolites will be observed before and after treatment.
Management information
Registered date
| 2024 | Year | 07 | Month | 05 | Day |
Last modified on
| 2024 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062726
