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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04391361
Other study ID # lj11128
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date November 1, 2020
Est. completion date October 31, 2023

Study information

Verified date October 2020
Source Ruijin Hospital
Contact Jun Liu, Professor
Phone 64370045
Email jly0520@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date October 31, 2023
Est. primary completion date September 30, 2023
Accepts healthy volunteers No
Gender All
Age group 30 Years to 65 Years
Eligibility Inclusion Criteria:

1. Patients should voluntarily participate in the experiment by signing an informed consent form.

2. Patients should comply with the research process and cooperate with the interventions applied throughout the experiment.

3. Patients should be between 30 and 65 years of age, and both sexes are acceptable.

4. 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.

5. Patient's amyotrophic lateral sclerosis history must not exceed 5 years.

6. ALS functional scale score (ALSFRS-R) should be = 2 points for each patients.

Exclusion Criteria:

1. Patients with cardiac conduction block, severe ventricular insufficiency, severe hepatorenal insufficiency and severe, progressive or uncontrolled major organ and systemic disease.

2. High or low blood pressure: systolic blood pressure >150 or <110 mmHg; bradycardia (<60 beats per minute).

3. Patients with ventilator-assisted ventilation.

4. Patients who are allergic to research intervention drugs.

5. Patients with obvious signs of dementia.

6. Female patients who are pregnant or breastfeeding or who have a plan to become pregnant in the near future.

7. Persons with other psychiatric disorders that may affect the assessment of their condition.

8. Severely obese patients (BMI >35kg/m2).

Study Design


Intervention

Drug:
Scopolamine, atropine, edaravone and dexmedetomidine
The patients were treated with scopolamine, atropine, edaravone and dexmedetomidine dissolved in saline.
Edaravone
The patients was treated with edaravone dissolved in the same volume of saline as the intervention applied in the experimental group.

Locations

Country Name City State
China Department of neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Secondary Effective Partial pressure of oxygen (PO2), maximum displacement of the hyoid or the modified Norris scale score (minimum score: 0, maximum score: 100, higher score is related to a better outcome) was elevated or partial pressure of carbon dioxide (PCO2) was decreased or remained unchanged. 48 weeks
Secondary Ineffective Partial pressure of carbon dioxide (PCO2) was elevated, or partial pressure of oxygen (PO2), maximum displacement of the hyoid or the modified Norris scale score (minimum score: 0, maximum score: 100, higher score is related to a better outcome) was decreased or remained unchanged. 48 weeks
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