Analysis of clinical trial characteristics of amyotrophic lateral sclerosis based on ClinicalTrials.gov and ChiCTR
AIM To explore the characteristics of clinical trials of amyotrophic lateral sclerosis(ALS).METHODS Clinical trials of ALS were retrieved in the ClinicalTrials.gov and Chinese clinical trial registry(ChiCTR)from inception to Dec 10,2023.The data were extracted and analyzed including the registration numbers,country,trial phases,interventions,outcomes and other aspects.RESULTS A total of 765 clinical trials were registered in ClinicalTrials.gov and the interventional trials(540 items)predominated.However,only 31 items were registered in ChiCTR.The United States was the primary site for ALS clinical trials,which carried out 250 studies,and owned the most number of applicants.Moreover,broad cooperation between North America and Europe was conducted.Most of the clinical trials were phase Ⅱ.Suspended and terminated trials were relatively less.The revised EI Escorial criterion was widely used in clinical trials.Drug therapy was the main intervention measure.Recently,the research was focused on decreasing abnormal proteins and relieving the neuroinflammation.Besides,the revised ALS functional rating scale(ALSFRS-R)was the widest used index of effect evaluation.CONCLUSION At present,the total number of clinical trials of ALS is small,but it is increasing.And new treatments appear continuously.However,there are obvious differences in research quantity and innovation at home and abroad,and international and inter-regional cooperation needs to be strengthened.
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