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Sponsor study identifier
interventional
30
1 country
1
Study Start
November 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Thirty cases of amyotrophic lateral sclerosis patients were recruited from the neurology department of Ruijin Hospital, the pain department and the encephalopathy center of Luwan Branch of Ruijin Hospital. After the informed consent was signed, they were divided into a trial group and a control group. Each group contains 15 cases. The patients in the control group was treated with edaravone dissolved in saline during hospitalization, while the patients in the trial group was treated with edaravone, scopolamine, atropine and dexmedetomidine. Both groups of subjects were treated for 7 days within 3 weeks, followed by a buffer period of 3 weeks for observation, which was one treatment course. The total treatment protocol contains 3 treatment courses (or 18 weeks). Patients with amyotrophic lateral sclerosis were evaluated before treatment and 6, 12, 18, 24, 36, 48 weeks after treatment. The observations include whether the functional scores of patients with amyotrophic lateral sclerosis, Norris amyotrophic lateral sclerosis score, amyotrophic lateral sclerosis self-score, forced expiratory volume in one second, partial pressure of oxygen and maximum displacement of the hyoid were superior to those before treatment, and whether the partial pressure of carbon dioxide was inferior to those before treatment. Study hypothesis: Cholinergic receptor blocking therapy for amyotrophic lateral sclerosis is safe and effective in improving motor function and delaying disease progression in patients with amyotrophic lateral sclerosis.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 13, 2020
Actual (reported)May 18, 2020
Actual (reported)November 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Effective
Forced expiratory volume in one second (FVC%) or ALS functional rating scale score (ALSFR, minimum score: 0, maximum score: 48, higher score is related to a better outcome) was elevated.
48 weeks
Ineffective
Forced expiratory volume in one second (FVC%) or ALS functional rating scale score (ALSFR, minimum score: 0, maximum score: 48, higher score is related to a better outcome) was decreased or remained unchanged.
48 weeks
Effective
48 weeks
Ineffective
48 weeks
The patients were treated with scopolamine, atropine, edaravone and dexmedetomidine dissolved in saline.
The patients was treated with edaravone dissolved in the same volume of saline as the intervention applied in the experimental group.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Scopolamine, atropine, edaravone and dexmedetomidine
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordDepartment of neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025, China
Jun Liu, Professor
Department of Neurology, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine
First Submitted
May 13, 2020
First Posted
May 18, 2020
Study Start
November 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 30, 2023
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 14, 2020
Record last verified: 2020-10
No individual participant data (IPD) was available to other researchers.
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Source: ClinicalTrials.gov.
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