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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030341
Receipt No. R000034630
Scientific Title Clinical study of tolcapone for transthyretin (TTR)-type cerebral amyloid angiopathy in patients with familial amyloid polyneuropahty (FAP)
Date of disclosure of the study information 2018/01/01
Last modified on 2017/12/11

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Basic information
Public title Clinical study of tolcapone for transthyretin (TTR)-type cerebral amyloid angiopathy in patients with familial amyloid polyneuropahty (FAP)
Acronym Clinical study of tolcapone for ATTR-type CAA
Scientific Title Clinical study of tolcapone for transthyretin (TTR)-type cerebral amyloid angiopathy in patients with familial amyloid polyneuropahty (FAP)
Scientific Title:Acronym Clinical study of tolcapone for ATTR-type CAA
Region
Japan

Condition
Condition Familial amyloid polyneuropahty
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 pharmacokinetics
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes stability ratio of CSF TTR tetramer
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Administer tolcapone at 300 mg/day orally for 7 days.
Interventions/Control_2 Administer tolcapone at 600 mg/day orally for 7 days.
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 Biopsy proven amyloid deposition
Genotyping of variant TTR
Age > 20
Key exclusion criteria Asymptomatic mutation carriers
Contraindication for tolcapone
An ALT or AST measurement > 2 times the ULN (Upper Limit of Normal)
Treatment with NSAID or a known TTR binder within the last 4 weeks
Stage 3 disease
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiki Sekijima
Organization Shinshu University School of Medicine
Division name Department of Medicine (Neurology & Rheumatology)
Zip code
Address 3-1-1 Asahi, Matsumoto 390-8621, Japan
TEL 0263372673
Email sekijima@shinshu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiki Sekijima
Organization Shinshu University School of Medicine
Division name Department of Medicine (Neurology & Rheumatology)
Zip code
Address 3-1-1 Asahi, Matsumoto 390-8621, Japan
TEL 0263372673
Homepage URL
Email sekijima@shinshu-u.ac.jp

Sponsor
Institute Shinshu University School of Medicine
Institute
Department

Funding Source
Organization Corino Therapeutics, Inc.
Organization
Division
Category of Funding Organization Outside Japan
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
2018 Year 01 Month 01 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
2017 Year 12 Month 06 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 12 Month 11 Day
Last modified on
2017 Year 12 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034630

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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