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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006103
Receipt No. R000007221
Scientific Title Open label and single cohort study of edaravon on Muro disease (amyotrophic lateral sclerosis and parkinsonism-dementia complex :Kii ALS/PDC)
Date of disclosure of the study information 2011/08/20
Last modified on 2014/02/04

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Basic information
Public title Open label and single cohort study of edaravon on Muro disease (amyotrophic lateral sclerosis and parkinsonism-dementia complex :Kii ALS/PDC)
Acronym Edaravon on Muro disease (Kii ALS/PDC)
Scientific Title Open label and single cohort study of edaravon on Muro disease (amyotrophic lateral sclerosis and parkinsonism-dementia complex :Kii ALS/PDC)
Scientific Title:Acronym Edaravon on Muro disease (Kii ALS/PDC)
Region
Japan

Condition
Condition Muro disease (amyotrophic lateral sclerosis and parkinsonism-dementia complex : Kii : ALS/PDC)
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate edaravon on Muro disease (amyotrophic lateral sclerosis and parkinsonism-dementia complex : Kii : ALS/PDC)
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes CAS/CAT,motivation score in Japan
Key secondary outcomes 1. ALSFRS-R, 2.UPDRS, 3. MMSE, 4. FAB

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Edaravon, 6 months
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1) Patients who live or have lived in ALS/PDC focus of Mie prefecture.
2) ALS: probable ALS diagnosed by El Escorial criteria. PDC: patients with dementia and parkinsonism.
3) Range of Age: 20 y.o -80 y.o.
4) Requirement a caregiver of patient.
5) Patients who can take a medical examination at Minami Ise Hospital regularly.
6) Informed consent.
Key exclusion criteria 1) A patient with other neuronal or muscular disorders
2) A patients with systemic disorders those present dementia, parkinsonism or amyotrophy
3) Encephalitis
4) A patients with abnormal neuroradiological findings those suggest other disorders present dementia, parkinsonism or amyotrophy
5) A patients with severe psychiatric disorders
6) A patient with malignancy
7) A patient with severe renal dysfunction
8) A patient wit sever heart dysfunction
9) A patient with severe liver dysfunction
10) A patient with sever drug allergy
11) A patients with drug or alcoholic abuse
12) A patient with pregnancy or in the lactation period
13) A patient who was inappropriate for this study
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasumasa Kokubo
Organization Mie University, Graduate School of Regional Innovation Studies
Division name Kii ALS/PDC Research Center
Zip code
Address 1577, Kurima-machiyamachi, Tsu, Mie
TEL +81-59-231-5117
Email ktyktykty@me.com

Public contact
Name of contact person
1st name
Middle name
Last name Junko Karita
Organization Mie University, Graduate School of Regional Innovation Studies
Division name Kii ALS/PDC Research Center
Zip code
Address 1577, Kurima-machiyamachi, Tsu, Mie
TEL +81-59-231-5117
Homepage URL http://kii-als-pdc-project.com
Email kii-project@clin.medic.mie-u.ac.jp

Sponsor
Institute Mie University, Graduate School of Regional Innovation Studies
Institute
Department

Funding Source
Organization Research Project for Japan Intractable diseases
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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 町立南伊勢病院 (三重県) (Minami Ise Town Hospital), 三重大学病院 (三重県) (Mie University Hospital)

Other administrative information
Date of disclosure of the study information
2011 Year 08 Month 20 Day

Related information
URL releasing protocol http://kii-als-pdc-project.com
Publication of results Published

Result
URL related to results and publications http://kii-als-pdc-project.com
Number of participants that the trial has enrolled
Results Background: The purpose of this study was to reveal the clinical effect of edaravone, a free radical scavenger, in patients with amyotrophic lateral sclerosis/parkinsonism-dementia complex in the Kii Peninsula area of Japan (Kii ALS/PDC).
Objective: Five patients with Kii ALS/PDC (four men and one woman; mean age, 68.4 years; mean duration of illness, 9.4 years) were included in the study.
Method: Edaravone (30 mg per infusion) was administered twice a week for 24 weeks via intravenous drip to the patients with Kii ALS/PDC. Ascorbic acid (2000 mg/day) and tocopherol acetate (300 mg/day) were used concomitantly.
Results: Two of the five patients with relatively mild symptoms showed improvement of spontaneity, mental, and physical activity and one of them with the mildest symptoms showed marked improvement on the Unified Parkinson Disease Rating Scale, apathy scale, and Clinical Assessment for Spontaneity. The other patient showed no apparent change. The remaining two bed-ridden patients showed irritability, violence, and hypersexuality; hence, edaravone was discontinued for three months.
Discussion: Edaravone may be effective for patients in the mild-to moderate stage of Kii ALS/PDC, but a further large-scale trial will be needed to confirm this finding.
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 07 Month 20 Day
Date of IRB
Anticipated trial start date
2011 Year 12 Month 01 Day
Last follow-up date
2012 Year 05 Month 31 Day
Date of closure to data entry
2012 Year 09 Month 30 Day
Date trial data considered complete
2012 Year 09 Month 30 Day
Date analysis concluded
2013 Year 01 Month 31 Day

Other
Other related information

Management information
Registered date
2011 Year 08 Month 02 Day
Last modified on
2014 Year 02 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007221

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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