UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Edrophonium challenge test for dystonia
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Shinichi Matsumoto
Organization	Shinko Hospital
Division name	Department of Neurology
Address	Wakihamacho Chuouku, Kobe 651-0072, Japan
TEL	0782616739
Email	dyt1mc@yahoo.co.jp

Public contact
Name of contact person	Shinichi Matsmoto
Organization	Shinko Hospital
Division name	Department of Neurology
Address	Wakihamacho Chuouku, Kobe 651-0072, Japan
TEL	0782616739
Homepage URL
Email	dyt1mc@yahoo.co.jp

Sponsor
Institute	Shinko Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 06 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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