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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| trial group | Experimental |
| |
| control group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Scopolamine, atropine, edaravone and dexmedetomidine | Drug | The patients were treated with scopolamine, atropine, edaravone and dexmedetomidine dissolved in saline. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Ineffective |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Liu, Professor | Contact | 64370045 | +86-021 | jly0520@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jun Liu, Professor | Department of Neurology, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai Municipality | 200025 | China |
No individual participant data (IPD) was available to other researchers.
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| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
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| ID | Term |
|---|---|
| D012601 | Scopolamine |
| D001285 | Atropine |
| D000077553 | Edaravone |
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
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| Edaravone | Drug | The patients was treated with edaravone dissolved in the same volume of saline as the intervention applied in the experimental group. |
|
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 |
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009930 |
| Organic Chemicals |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D001286 | Atropine Derivatives |
| D000983 | Antipyrine |
| D047069 | Pyrazolones |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D007093 | Imidazoles |