UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001455 |
|---|---|
| Receipt number | 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 22:36:53 |
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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
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
Sponsor or person
Institute
Department of Neurology
Chiba University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001763
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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