Status:
UNKNOWN
The Safety and Effectiveness of Cholinergic Receptor Block Therapy in the Treatment of ALS
Lead Sponsor:
Ruijin Hospital
Conditions:
Amyotrophic Lateral Sclerosis
Respiratory Function
Eligibility:
All Genders
30-65 years
Phase:
PHASE2
Brief Summary
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 Hosp...
Eligibility Criteria
Inclusion
- Patients should voluntarily participate in the experiment by signing an informed consent form.
- Patients should comply with the research process and cooperate with the interventions applied throughout the experiment.
- Patients should be between 30 and 65 years of age, and both sexes are acceptable.
- Patients should comply with the diagnostic criteria and exclusion criteria for amyotrophic lateral sclerosis in the Chinese Guidelines for the Diagnosis and Treatment of Amyotrophic Lateral Sclerosis developed by the Chinese Society of Neurology of the Chinese Medical Association in 2012.
- Patient's amyotrophic lateral sclerosis history must not exceed 5 years.
- ALS functional scale score (ALSFRS-R) should be ≥ 2 points for each patients.
Exclusion
- Patients with cardiac conduction block, severe ventricular insufficiency, severe hepatorenal insufficiency and severe, progressive or uncontrolled major organ and systemic disease.
- High or low blood pressure: systolic blood pressure \>150 or \<110 mmHg; bradycardia (\<60 beats per minute).
- Patients with ventilator-assisted ventilation.
- Patients who are allergic to research intervention drugs.
- Patients with obvious signs of dementia.
- Female patients who are pregnant or breastfeeding or who have a plan to become pregnant in the near future.
- Persons with other psychiatric disorders that may affect the assessment of their condition.
- Severely obese patients (BMI \>35kg/m2).
Key Trial Info
Start Date :
November 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04391361
Start Date
November 1 2020
End Date
October 31 2023
Last Update
October 14 2020
Active Locations (1)
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1
Department of neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025