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

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ClinicalTrials.gov Identifier: NCT04391361
Recruitment Status : Not yet recruiting
First Posted : May 18, 2020
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
Ruijin Hospital

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.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Respiratory Function Scopolamine Drug: Scopolamine, atropine, edaravone and dexmedetomidine Drug: Edaravone Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Safety and Effectiveness of Cholinergic Receptor Block Therapy in the Treatment of Amyotrophic Lateral Sclerosis
Estimated Study Start Date : November 1, 2020
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : October 31, 2023


Arm Intervention/treatment
Experimental: trial group Drug: Scopolamine, atropine, edaravone and dexmedetomidine
The patients were treated with scopolamine, atropine, edaravone and dexmedetomidine dissolved in saline.

Placebo Comparator: control group Drug: Edaravone
The patients was treated with edaravone dissolved in the same volume of saline as the intervention applied in the experimental group.




Primary Outcome Measures :
  1. Effective [ Time Frame: 48 weeks ]
    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.

  2. Ineffective [ Time Frame: 48 weeks ]
    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.


Secondary Outcome Measures :
  1. Effective [ Time Frame: 48 weeks ]
    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.

  2. Ineffective [ Time Frame: 48 weeks ]
    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.



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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04391361


Contacts
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Contact: Jun Liu, Professor 64370045 ext +86-021 jly0520@hotmail.com

Locations
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China, Shanghai
Department of neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai, China, 200025
Contact: Jun Liu, Professor    64370045 ext +86-021    jly0520@hotmail.com   
Sponsors and Collaborators
Ruijin Hospital
Investigators
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Study Chair: Jun Liu, Professor Department of Neurology, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine
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Responsible Party: Ruijin Hospital
ClinicalTrials.gov Identifier: NCT04391361    
Other Study ID Numbers: lj11128
First Posted: May 18, 2020    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No individual participant data (IPD) was available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Atropine
Scopolamine
Dexmedetomidine
Edaravone
Butylscopolammonium Bromide
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action