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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022557
Receipt No. R000025986
Scientific Title Edrophonium challenge test for dystonia
Date of disclosure of the study information 2016/06/01
Last modified on 2016/05/31

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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
Email 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
Email dyt1mc@yahoo.co.jp

Sponsor
Institute Shinko Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025986

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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