UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003444 |
|---|---|
| Receipt number | R000004162 |
| Scientific Title | Prospective observational study in patients with spinal and bulbar muscular atrophy (SBMA) who completed the phase 3 clinical trial of TAP-144-SR (3M) . |
| Date of disclosure of the study information | 2010/04/02 |
| Last modified on | 2012/12/10 14:39:59 |
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Basic information
Public title
Prospective observational study in patients with spinal and bulbar muscular atrophy (SBMA) who completed the phase 3 clinical trial of TAP-144-SR (3M) .
Acronym
Prospective observational study in patients with SBMA who completed the phase 3 clinical trial of TAP-144-SR (3M).
Scientific Title
Prospective observational study in patients with spinal and bulbar muscular atrophy (SBMA) who completed the phase 3 clinical trial of TAP-144-SR (3M) .
Scientific Title:Acronym
Prospective observational study in patients with SBMA who completed the phase 3 clinical trial of TAP-144-SR (3M).
Region
| Japan |
Condition
Condition
Spinal and Bulbar Muscular Atrophy
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the change in disease condition of patients with SBMA after stopping administration of Leuprorelin acetate
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Motor functions and QOL (videofluorographic and manometric examination of swallowing, 6-minute walk, ALSFRS-R, QMG Score, ALSAQ-5)
Key secondary outcomes
Blood Pressure, Body Weight, Bone Mineral Density,
Serum Creatine Kinase, Testosterone, Blood Glucose, HbA1c
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
| 30 | years-old | <= |
Age-upper limit
| 71 | years-old | > |
Gender
Male
Key inclusion criteria
(1)Patients who completed the phase 3 clinical trial of TAP-144-SR (3M) at the University of Tokyo Hospital
(2)Patients with written informed consent.
Key exclusion criteria
Patients judged as inappropriate to this study by investigators.
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomotaka Yamamoto |
Organization
The University of Tokyo Hospital
Division name
Department of Neurology
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411ext33783
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
The University of Tokyo Hospital
Division name
Department of Neurology
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411ext33783
Homepage URL
Sponsor or person
Institute
Neurology, the University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
東京大学医学部附属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 04 | Month | 02 | 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
Completed
Date of protocol fixation
| 2009 | Year | 11 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The aim of this study is to evaluate the change in disease condition of patients with SBMA after stopping administration of Leuprorelin acetate by prospectively observing the patients who completed the phase 3 clinical trial of TAP-144-SR (3M) at the University of Tokyo Hospital.
Management information
Registered date
| 2010 | Year | 04 | Month | 02 | Day |
Last modified on
| 2012 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004162
