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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000474
Receipt No. R000000572
Scientific Title Double-blind Placebo-controlled Clinical Trial of Leuprorelin acetate in Patients with Spinal and Bulbar Muscular Atrophy (SBMA)
Date of disclosure of the study information 2006/09/01
Last modified on 2009/08/02

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Basic information
Public title Double-blind Placebo-controlled Clinical Trial
of Leuprorelin acetate in Patients with Spinal and Bulbar Muscular Atrophy (SBMA)
Acronym Clinical Trial of Leuprorelin acetate in Patients with SBMA
Scientific Title Double-blind Placebo-controlled Clinical Trial
of Leuprorelin acetate in Patients with Spinal and Bulbar Muscular Atrophy (SBMA)
Scientific Title:Acronym Clinical Trial of Leuprorelin acetate in Patients with SBMA
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 leuprorelin acetate in patient with spinal and bulbar muscular atrophy (SBMA)
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Motor function(ALSFRS-R)
Key secondary outcomes Frequency of aspiration pneumonia,
serum creatine kinase, serum testosterone, liver function test, HbA1c, NCV, immunohistological study of scrotal skin biopsy and Respiratory function test.

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 Leuprorelin acetate 3.75 mg subcutaneous injection every 4 weeks
Interventions/Control_2 Placebo subcutaneous injection every 4 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 Genetically confirmed SBMA male patients in Japan who have no desire to father a child with written informed consent.
Key exclusion criteria 1) Patients with past medical history of allergy to leuprorelin acetate
2) Patients who have severe complications and are not appropriate to participate to the trial..
3) Patients who have taken testosterone within 8 weeks prior to the informed consent.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Gen Sobue
Organization Nagoya University, 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
Organization Nagoya University, School of Medicine
Division name Department of Neurology
Zip code
Address 65 Tsurumai, Showa-ku, Nagoya, Aichi
TEL 052-744-2390
Homepage URL
Email sbma@med.nagoya-u.ac.jp

Sponsor
Institute Department of Neurology, Nagoya University School of Medicine
Institute
Department

Funding Source
Organization Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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
2006 Year 09 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

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
2003 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2003 Year 09 Month 01 Day
Last follow-up date
2005 Year 02 Month 01 Day
Date of closure to data entry
2005 Year 06 Month 01 Day
Date trial data considered complete
2005 Year 07 Month 01 Day
Date analysis concluded
2005 Year 09 Month 01 Day

Other
Other related information

Management information
Registered date
2006 Year 08 Month 15 Day
Last modified on
2009 Year 08 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000572

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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