UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022557 |
|---|---|
| Receipt number | R000025986 |
| Scientific Title | Edrophonium challenge test for dystonia |
| Date of disclosure of the study information | 2016/06/01 |
| Last modified on | 2016/05/31 19:51:10 |
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Basic information
Public title
Edrophonium challenge test for dystonia
Acronym
Edrophonium test for dystonia
Scientific Title
Edrophonium challenge test for dystonia
Scientific Title:Acronym
Edrophonium test for dystonia
Region
| Japan |
Condition
Condition
10 patients with blepharospasm, 10 patients with hemifacial spasms, 10 patients with cervical dystonia, 10 patients with hand dystonia, 10 patients with essential tremor8cervical), 10 patients with essential tremor(hand)
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Whether an edrophonium challenge test would be useful for diagnosing dystonia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We evaluated the subjective symptoms and objective symptoms by visual analog scale
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
6
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
edrophonium1V 10 min/isotonic saline 10ml 10 min
Interventions/Control_2
edrophonium1V 10 min/isotonic saline 10ml 10 min
Interventions/Control_3
edrophonium1V 10 min/isotonic saline 10ml 10 min
Interventions/Control_4
edrophonium1V 10 min/isotonic saline 10ml 10 min
Interventions/Control_5
edrophonium1V 10 min/isotonic saline 10ml 10 min
Interventions/Control_6
edrophonium1V 10 min/isotonic saline 10ml 10 min
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 15 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All participants were examined by a single movement disorder specialist, who performed general physical and neurological examinations, laboratory tests, and brain magnetic resonance imaging in order to exclude other causes of dystonia, including birth injury and head trauma.
Key exclusion criteria
1. Less than 15 years old
2. Those with other diseases
3. Severe renal failure, those with liver failure
4. Those that are pregnant, and those that do not take an effective means for contraception in women of childbearing age.
5. Other, which is determined to be unsuitable for the present study.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichi Matsumoto |
Organization
Shinko Hospital
Division name
Department of Neurology
Zip code
Address
Wakihamacho Chuouku, Kobe 651-0072, Japan
TEL
0782616739
dyt1mc@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinichi Matsmoto |
Organization
Shinko Hospital
Division name
Department of Neurology
Zip code
Address
Wakihamacho Chuouku, Kobe 651-0072, Japan
TEL
0782616739
Homepage URL
dyt1mc@yahoo.co.jp
Sponsor or person
Institute
Shinko Hospital
Institute
Department
Personal name
Funding Source
Organization
Shinko Hospital
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
| 2016 | Year | 06 | Month | 01 | 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
Completed
Date of protocol fixation
| 2011 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 31 | Day |
Last modified on
| 2016 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025986
| 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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| Registered date | File name |
