Open label and single cohort study of edaravon on Muro disease (amyotrophic lateral sclerosis and parkinsonism-dementia complex :Kii ALS/PDC)

Phase 2

• Conditions: Muro disease (amyotrophic lateral sclerosis and parkinsonism-dementia complex : Kii : ALS/PDC)

• Registration Number: JPRN-UMIN000006103
• Lead Sponsor: Mie University, Graduate School of Regional Innovation Studies

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-08-20
• Study Completion: 2012-05-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified