UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000465 |
|---|---|
| Receipt number | R000000563 |
| Scientific Title | Double-blind Placebo-controlled 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 | 2006/09/05 |
| Last modified on | 2008/08/08 12:32:47 |
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Basic information
Public title
Double-blind Placebo-controlled Phase III Clinical Trial
of TAP-144-SR (3M) in Patients with Spinal and Bulbar Muscular Atrophy (SBMA)
Acronym
Phase III Clinical Trial of Leuprorelin acetate in Patients with SBMA (JASMITT)
Scientific Title
Double-blind Placebo-controlled Phase III Clinical Trial
of TAP-144-SR (3M) in Patients with Spinal and Bulbar Muscular Atrophy (SBMA)
Scientific Title:Acronym
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
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety 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
Assessment
Primary outcomes
Pharyngeal barium residue (%)
in videofluorography
Key secondary outcomes
Frequency of anti-poly Q staining in Scrotal Skin
Clinical scores (ALSFRS-R, QMG Score, 6-minute walk)
QOL (ALSAQ-5)
serum creatine kinase (CK)
parameters in videofluorography
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
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
Placebo subcutaneous injection every 12 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
| 30 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male
Key inclusion criteria
1) Clinically and/or genetically confirmed SBMA male patients in Japan who have more than one symptoms including muscle weakness, muscle atrophy, bulbar palsy and hand tremor.
2) Patients whose repeat number of CAG in androgen receptor gene is more than 38 in screening gene analysis.
3) Patients who are age 30 to 70 year-old at the time of informed consent.
4) Patients who have no desire to father a child.
5) Patients whose liver function test and renal function test are within below limits.
AST (GOT) smaller than 4.0 X upper limit of normal
ALT (GPT) smaller than 4.0 X upper limit of normal
Creatinine smaller than 1.5 X upper limit of normal
6) Patients who are capable of standing for 6 min with or without cane.
7) Patients who are capable of undergoing in hospital examinations at 0, 24th, 48th week and the time of quitting the trial.
8) Patients who are capable of ambulatory hospital visits.
9) Patients with written informed consent.
Key exclusion criteria
1) Patients who have taken LH-RH agonists, testosterone drugs, 5-alpha-reductase inhibitors, anti-androgen drugs or estrogen drugs within 48 weeks prior to the informed consent.
2) Patients who have taken LH-RH agonists for more than 48 weeks prior to the informed consent.
3) Patients who have undergone operations (eg. orchiectomy), which reduce serum testosterone levels.
4) Patients who are unable to undergo skin biopsies.
5) Patients who are unable to undergo videofluorography.
6) Patients who are diagnosed being depressed by M.I.N.I. Japanese version 5.0.0 major depression episode.
7) Patients who have severe complications.
8) Patients who have suffered angina pectoris or myocardial infarction within one month prior to the informed consent.
9) Heart rate > 120 bpm, systolic BP > 180mmHg or diastolic BP > 100 mmHg.
10) Patients with past medical history of allergy to leuprorelin acetate, synthetic LH-RH or LH-RH delivatives.
11) Patients who have participated in other clinical trials within 12 weeks prior to the informed consent.
12) Patients who are not appropriate to participate to the trial.
Target sample size
170
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
Department of Neurology
Zip code
Address
65 Tsurumai, Showa-ku, Nagoya, Aichi
TEL
052-744-2385
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Haruhiko Banno |
Organization
Department of Neurology, 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
Homepage URL
http://www.jmacct.med.or.jp/topics/topic25.html
sbma@med.nagoya-u.ac.jp
Sponsor or person
Institute
Center for Clinical Trials, Japan Medical Association
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, Chiba, Tokyo med & dental, Niigata, Kobe, Tottori, Nagasaki and Kumamoto univ, Jichi med college, Univ of Tokyo, NHO Sagamihara hosp, Hamamatsu med college.
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
| 2006 | Year | 09 | Month | 05 | Day |
Related information
URL releasing protocol
http://www.jmacct.med.or.jp/topics
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
| 2006 | Year | 08 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2006 | Year | 08 | Month | 08 | Day |
Last modified on
| 2008 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000563
