UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001010 |
|---|---|
| Receipt number | R000001217 |
| Scientific Title | Long Term Follow-up Phase III Clinical Trial of TAP-144-SR (3M) in Patients with Spinal and Bulbar Muscular Atrophy (SBMA) |
| Date of disclosure of the study information | 2008/02/01 |
| Last modified on | 2010/08/01 18:35:24 |
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Basic information
Public title
Long Term Follow-up Phase III Clinical Trial of TAP-144-SR (3M) in Patients with Spinal and Bulbar Muscular Atrophy (SBMA)
Acronym
Long Term Follow-up Phase III Clinical Trial of Leuprorelin acetate in Patients with SBMA (JASMITT)
Scientific Title
Long Term Follow-up Phase III Clinical Trial of TAP-144-SR (3M) in Patients with Spinal and Bulbar Muscular Atrophy (SBMA)
Scientific Title:Acronym
Long Term Follow-up Phase III Clinical Trial of Leuprorelin acetate in Patients with SBMA (JASMITT)
Region
| Japan |
Condition
Condition
Spinal and Bulbar Muscular Atrophy (SBMA)
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To evaluate efficacy and safety of long term use of TAP-144-SR(3M) in patient with spinal and bulbar muscular atrophy (SBMA)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Pharyngeal barium residue (%)
in videofluorography
Key secondary outcomes
Clinical scores (ALSFRS-R, QMG Score, 6-minute walk)
QOL (ALSAQ-5)
serum creatine kinase (CK)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
TAP-144-SR(3M) 11.25mg subcutaneous
injection every 12 weeks
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 finished double-blind placebo-controlled phase III clinical trial
of TAP-144-SR (3M) in patients with spinal and bulbar muscular atrophy (SBMA).
2) Patients who have no desire to father a child.
3) Patients with written informed consent.
4) Patients who are capable of ambulatory hospital visits.
Key exclusion criteria
1) Patients who have met the termination criteria for the double-blind placebo-controlled phase III clinical trial.
2) Patients who have taken LH-RH agonists, testosterone drugs, 5-alpha-reductase inhibitors, anti-androgen drugs estrogen drugs or unapproved drugs after the recruitment of the double-blind placebo-controlled phase III clinical trial
3) Patients who have undergone operations (eg. orchiectomy), which reduce serum testosterone levels.
4) Patients who are unable to undergo videofluorography.
5) Patients who are diagnosed being depressed by M.I.N.I. Japanese version 5.0.0 major depression episode.
6) Patients who have severe complications.
7) Patients with past medical history of allergy to trial drugs in double-blind placebo-controlled phase III clinical trial.
8) Patients who are not appropriate to participate to the trial.
Target sample size
152
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Gen Sobue |
Organization
Nagoya University, Graduate School of Medicine
Division name
JASMITT Clinical Trial Office
Zip code
Address
65 Tsurumai, Showa-ku, Nagoya, Aichi
TEL
052-744-2390
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
JASMITT Clinical Trial Office
Division name
Department of Neurology, Nagoya University, School of Medicine
Zip code
Address
Tsurumai 65, Showa-ku, Nagoya, Aichi
TEL
052-744-2390
Homepage URL
sbma@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Neurology, Nagoya University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Center for Clinical Trials, Japan Medical Association
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Hokkaido, Tohoku Univ, Jichi Med College, Chiba Univ, Univ of Tokyo, Tokyo Medical and Dental Univ, NHO Sagamitara HP, Niigata Univ, Hamamatsu Med college, Kobe, Tottori, Nagasaki, Kumamoto Univ.
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
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 02 | 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
Completed
Date of protocol fixation
| 2007 | Year | 07 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 09 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2008 | Year | 02 | Month | 01 | Day |
Last modified on
| 2010 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001217
