The Safety and Effectiveness of Cholinergic Receptor Block Therapy in the Treatment of ALS

NCT ID: NCT04391361

Last Updated: 2020-10-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-01
• Study Completion Date: 2023-10-31

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 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.

Conditions

Amyotrophic Lateral Sclerosis; Respiratory Function; Scopolamine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

trial group

Group Type: EXPERIMENTAL

Scopolamine, atropine, edaravone and dexmedetomidine

Intervention Type: DRUG

The patients were treated with scopolamine, atropine, edaravone and dexmedetomidine dissolved in saline.

control group

Group Type: PLACEBO_COMPARATOR

Edaravone

Intervention Type: DRUG

The patients was treated with edaravone dissolved in the same volume of saline as the intervention applied in the experimental group.

Interventions

Scopolamine, atropine, edaravone and dexmedetomidine

The patients were treated with scopolamine, atropine, edaravone and dexmedetomidine dissolved in saline.

Intervention Type: DRUG

Edaravone

The patients was treated with edaravone dissolved in the same volume of saline as the intervention applied in the experimental group.

Intervention Type: DRUG

Eligibility Criteria

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.

Exclusion Criteria

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.

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).

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jun Liu, Professor

Role: STUDY_CHAIR

Department of Neurology, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine

Locations

Department of neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Jun Liu, Professor

Role: CONTACT

jly0520@hotmail.com

64370045 ext. +86-021

Facility Contacts

Jun Liu, Professor

Role: primary

jly0520@hotmail.com

64370045 ext. +86-021

Other Identifiers

lj11128

Identifier Type: -

Identifier Source: org_study_id