PMID- 38011420
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231129
IS  - 2717-011X (Electronic)
IS  - 2717-011X (Linking)
VI  - 20
IP  - 1
DP  - 2021 Jan 4
TI  - Safety and efficacy of edaravone in well-defined Iranian patients with 
      amyotrophic lateral sclerosis: A parallel-group single-blind trial.
PG  - 1-7
LID - 10.18502/cjn.v20i1.6373 [doi]
AB  - Background: This parallel-group single-blind trial evaluates the safety and 
      efficacy of Edaravone, as a free radical scavenger, in a highly selective 
      subgroup of Iranian patients with amyotrophic lateral sclerosis (ALS). Methods: 
      The study was registered in ClinicalTrials.gov (registration number: NCT03272802) 
      and Iranian Registry of Clinical Trials (registration number: 
      IRCT20190324043105N). Patients were included into the study, who were diagnosed 
      as probable or definite ALS (according to revised El Escorial criteria), mildly 
      to moderately affected by the disease [according to Amyotrophic Lateral Sclerosis 
      Health State Scale (ALS/HSS)], scored >/= 2 points on all items of the Revised 
      Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R), and had forced 
      vital capacity (FVC) of at least 80%. 20 patients (10 cases, 10 controls) were 
      observed for 12 cycles (each cycle lasted four weeks). Cases received Edaravone 
      for the first 14 days in the first cycle and for the first 10 days in the next 
      cycles. In addition, all patients received Riluzole. The 40-item Amyotrophic 
      Lateral Sclerosis Assessment Questionnaire (ALSAQ-40), ALSFRS-R, and Manual 
      Muscle Testing (MMT) scores were measured every 3 cycles to evaluate the physical 
      and functional status of the patients. Besides, injection reactions, adverse 
      events (AEs), and serious adverse events (SAEs) were measured during the study. 
      Results: ALSAQ-40, ALSFRS-R, and MMT scores were not significantly different 
      between cases and controls in 5 different time points. During the study, no 
      injection reactions were observed. AEs and SAEs were not significantly different 
      between cases and controls. Conclusion: Our data did not demonstrate efficacy of 
      Edaravone in ALS treatment, but showed its safety for use in patients with ALS. 
      Further studies are necessary to investigate Edaravone efficacy in patients with 
      ALS before prescribing this new drug outside Japan.
CI  - Copyright (c) 2021 Iranian Neurological Association, and Tehran University of 
      Medical Sciences Published by Tehran University of Medical Sciences.
FAU - Eishi-Oskouei, Alireza
AU  - Eishi-Oskouei A
AD  - Department of Neurology, School of Medicine, Isfahan University of Medical 
      Sciences, Isfahan, Iran.
AD  - Neuroscience Research Center, Isfahan University of Medical Sciences, Isfahan, 
      Iran.
AD  - Medical Student Research Center, Isfahan University of Medical Sciences, Isfahan, 
      Iran.
FAU - Basiri, Keivan
AU  - Basiri K
AD  - Department of Neurology, School of Medicine, Isfahan University of Medical 
      Sciences, Isfahan, Iran.
AD  - Neuroscience Research Center, Isfahan University of Medical Sciences, Isfahan, 
      Iran.
LA  - eng
SI  - ClinicalTrials.gov/NCT03272802
PT  - Journal Article
PL  - Iran
TA  - Curr J Neurol
JT  - Current journal of neurology
JID - 101769679
PMC - PMC8511600
OTO - NOTNLM
OT  - Amyotrophic Lateral Sclerosis
OT  - Radicava; Clinical Trial
OT  - Single-Blind Method
EDAT- 2021/01/04 00:00
MHDA- 2021/01/04 00:01
PMCR- 2021/01/04
CRDT- 2023/11/27 14:57
PHST- 2020/09/10 00:00 [received]
PHST- 2020/11/05 00:00 [accepted]
PHST- 2021/01/04 00:01 [medline]
PHST- 2021/01/04 00:00 [pubmed]
PHST- 2023/11/27 14:57 [entrez]
PHST- 2021/01/04 00:00 [pmc-release]
AID - CJN-20-1 [pii]
AID - 10.18502/cjn.v20i1.6373 [doi]
PST - ppublish
SO  - Curr J Neurol. 2021 Jan 4;20(1):1-7. doi: 10.18502/cjn.v20i1.6373.