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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000001455
Receipt No. R000001763
Scientific Title Open clinical trial of Leuprorelin Acetate (SR) in patients with Kennedy-Alter-Sung syndrome (KAS)
Date of disclosure of the study information 2008/10/23
Last modified on 2008/10/23

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Basic information
Public title Open clinical trial of Leuprorelin Acetate (SR) in patients with Kennedy-Alter-Sung syndrome (KAS)
Acronym Open clinical trial of Leuprorelin Acetate (SR) in patients with KAS
Scientific Title Open clinical trial of Leuprorelin Acetate (SR) in patients with Kennedy-Alter-Sung syndrome (KAS)
Scientific Title:Acronym Open clinical trial of Leuprorelin Acetate (SR) in patients with KAS
Region
Japan

Condition
Condition Kennedy-Alter-Sung syndrome (KAS)
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy and safety and to investigate neuropysiological basis of treatment effect of leuprorelin in patients with KAS
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Pharyngeal barium residue in videofluorography
Key secondary outcomes serum CK, parameters in videofluorography, frequency of 1C2 antibody staining in scrotal skin, clinical scores, clinical scores, QOL scores, parameters in electrophysiological testings

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 Leuprorelin acetate (SR) 11.25mg subcutaneous infection per 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
20 years-old <=
Age-upper limit

Not applicable
Gender Male
Key inclusion criteria Genetically confirmed KAS patients with written informed concent, who have no desire to father achild, no severe disturbance in liver and renal functions, and can stand for 6 min.
Key exclusion criteria "1) Patients who have taken any drugs which effect serum teststerone level within 48 weeks prior to the informed consent.
2) Patients who have taken any drugs which rduce serum teststerone level for more than 48 weaks prior to the informed concent.
3) Patients who have undergone surgical castration.
4) Patients with major depression.
5) Patients who have severe complications including sereve hypertention.
6) Patients who cannot undergo the clinical tests included in this trial.
7) Patients with allergy to leuprorelin acetate.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuaki Kanai
Organization Chiba University Graduate School of Medicine Hospital
Division name Department of Neurology
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Chiba University Graduate School of Medicine
Division name Department of Neurology
Zip code
Address
TEL 043-222-7171-(5414)
Homepage URL
Email

Sponsor
Institute Department of Neurology
Chiba University Graduate School of Medicine
Institute
Department

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
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
2008 Year 10 Month 23 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
Date of protocol fixation
2008 Year 01 Month 09 Day
Date of IRB
Anticipated trial start date
2008 Year 10 Month 01 Day
Last follow-up date
2014 Year 02 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2008 Year 10 Month 23 Day
Last modified on
2008 Year 10 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001763

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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