The Safety and Effectiveness of Cholinergic Receptor Block Therapy in the Treatment of ALS
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Nov 2020
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 13, 2020
CompletedFirst Posted
Study publicly available on registry
May 18, 2020
CompletedStudy Start
First participant enrolled
November 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2023
CompletedOctober 14, 2020
October 1, 2020
2.9 years
May 13, 2020
October 9, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (2)
Effective
48 weeks
Ineffective
48 weeks
Study Arms (2)
trial group
EXPERIMENTALcontrol group
PLACEBO COMPARATORInterventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patient's amyotrophic lateral sclerosis history must not exceed 5 years.
- ALS functional scale score (ALSFRS-R) should be ≥ 2 points for each patients.
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ruijin Hospitallead
Study Sites (1)
Department of neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jun Liu, Professor
Department of Neurology, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2020
First Posted
May 18, 2020
Study Start
November 1, 2020
Primary Completion
September 30, 2023
Study Completion
October 31, 2023
Last Updated
October 14, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share
No individual participant data (IPD) was available to other researchers.