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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000465
Receipt No. 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

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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
Email

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
Email sbma@med.nagoya-u.ac.jp

Sponsor
Institute Center for Clinical Trials, Japan Medical Association
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000563

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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