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 |
Open label and single cohort study of edaravon on Muro disease (amyotrophic lateral sclerosis and parkinsonism-dementia complex :Kii ALS/PDC)
Edaravon on Muro disease (Kii ALS/PDC)
Open label and single cohort study of edaravon on Muro disease (amyotrophic lateral sclerosis and parkinsonism-dementia complex :Kii ALS/PDC)
Edaravon on Muro disease (Kii ALS/PDC)
Japan |
Muro disease (amyotrophic lateral sclerosis and parkinsonism-dementia complex : Kii : ALS/PDC)
Neurology |
Others
NO
To evaluate edaravon on Muro disease (amyotrophic lateral sclerosis and parkinsonism-dementia complex : Kii : ALS/PDC)
Safety,Efficacy
Exploratory
Pragmatic
Phase II
CAS/CAT,motivation score in Japan
1. ALSFRS-R, 2.UPDRS, 3. MMSE, 4. FAB
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Edaravon, 6 months
20 | years-old | <= |
80 | years-old | >= |
Male and Female
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.
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
5
1st name | |
Middle name | |
Last name | Yasumasa Kokubo |
Mie University, Graduate School of Regional Innovation Studies
Kii ALS/PDC Research Center
1577, Kurima-machiyamachi, Tsu, Mie
+81-59-231-5117
ktyktykty@me.com
1st name | |
Middle name | |
Last name | Junko Karita |
Mie University, Graduate School of Regional Innovation Studies
Kii ALS/PDC Research Center
1577, Kurima-machiyamachi, Tsu, Mie
+81-59-231-5117
http://kii-als-pdc-project.com
kii-project@clin.medic.mie-u.ac.jp
Mie University, Graduate School of Regional Innovation Studies
Research Project for Japan Intractable diseases
Japan
NO
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)
2011 | Year | 08 | Month | 20 | Day |
http://kii-als-pdc-project.com
Published
http://kii-als-pdc-project.com
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.
Completed
2011 | Year | 07 | Month | 20 | Day |
2011 | Year | 12 | Month | 01 | Day |
2012 | Year | 05 | Month | 31 | Day |
2012 | Year | 09 | Month | 30 | Day |
2012 | Year | 09 | Month | 30 | Day |
2013 | Year | 01 | Month | 31 | Day |
2011 | Year | 08 | Month | 02 | Day |
2014 | Year | 02 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007221