UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006103 |
|---|---|
| Receipt number | 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 12:16:26 |
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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
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
kii-project@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Mie University, Graduate School of Regional Innovation Studies
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007221
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