UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Japanese, multicenter, randomized, double-blind, placebo-controlled, prospective study of AT-02 in patients with fibromyalgia
Title of the study (Brief title)	A Japanese, multicenter, randomized, double-blind, placebo-controlled, prospective study of AT-02 in patients with fibromyalgia
Region	Japan

Condition
Condition	Fibromyalgia
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of AT-02 in patients newly diagnosed with fibromyalgia or patients who have been diagnosed with fibromyalgia and treated with medical intervention in comparison with Sham control (S-01)
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The difference between the mean NRS in the Baseline Observation Period (6 days from Day -2 to Day 7 of the Baseline Observation Period) and the mean NRS at Week 8 of the Treatment Period
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	(1) AT-02 group AT-02 is an investigational medical device (unapproved) that concurrently produces multiple magnetic fields to promote pain relief.
Interventions/Control_2	(2) S-01 Sham group (Sham Control) A device that is inactive and does not produce magnetic fields, although it is completely indistinguishable from AT-02 (e.g., appearance, form, weight)
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	79 years-old >
Gender	Male and Female
Key inclusion criteria	(1)Age:Patients aged 20 years of age or older - <80 years (at the time of obtaining informed consent) (2)Patients meeting the diagnostic criteria for fibromyalgia (1990) from the American College of Rheumatology (ACR) (3)Patients with NRS 4 or more and persistent pain for 3 months or longer (4)Patients from whom written informed consent can be directly obtained
Key exclusion criteria	(1) Patients with expected survival less than 3 years due to malignancies or other reasons (2) Patients using life-sustaining electrical medical devices, such as artificial heart-lung devices (3) Patients using affixed electrical medical devices, such as ECG recorders (4) Patients who are participating in another clinical trial for a pharmaceutical product or medical device (5) Patients with dementia that seriously disturbs activities of daily life (6) Females who wish to become pregnant or are presently pregnant or nursing mothers (if the patient is a woman of childbearing potential, a pregnancy test must be performed) and others.
Target sample size	40

Research contact person
Name of lead principal investigator	Iwao Kishita
Organization	P-Mind Co. Ltd.
Division name	President
Address	3-37-24, Takahira, Kita-ku, Kumamoto City, Kumamoto, 860-0085
TEL	096-345-6600
Email	kishita.2011.1.11@p-mind.co.jp

Public contact
Name of contact person	Makoto Sawaguchi
Organization	Mebix Inc.
Division name	Research Promotion Division
Address	1-11-44, Akasaka, Minato-ku, Tokyo, 107-0052
TEL	03-4362-4500
Homepage URL
Email	angel@mebix.co.jp

Sponsor
Institute	P-Mind Co. Ltd.
Institute
Department

Funding Source
Organization	P-Mind Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
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 09 Month 12 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 08 Month 08 Day
Anticipated trial start date	2016 Year 09 Month 05 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 09 Month 12 Day
Last modified on	2017 Year 06 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027632