Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of this study is to evaluate the effect off Granulocyte Colony Stimulating Factor (GCSF) in the treatment of Amyotrophic Lateral Sclerosis (ALS) patients.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Granulocyte Colony Stimulating Factor | Active Comparator | Granulocyte Colony Stimulating Factor 10 microgram/ kg/ day for 5 days subcutaneously |
|
| Placebo | Placebo Comparator | normal saline 0.01 ml/kg/day for 5 days subcutaneously |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Granulocyte Colony Stimulating Factor | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| patient's function | based on revised ALS Functional Rating scale (ALSFRS-r) | one year |
| Measure | Description | Time Frame |
|---|---|---|
| mobilizing bone marrow stem cells | based on cluster of differentiation 34 (CD34) and white blood cell (WBC) counting | 1 year |
| amplitude of compound muscle action potential in ulnar and peroneal nerve |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Iranian Neurology Research Center of Tehran University of Medical Sciences | Tehran | Tehran Province | Iran |
Not provided
| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
Not provided
Not provided
| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
based on compound muscle action potential (CMAP) measured in nerve conduction study
| 1 year |
| quality of life | based on Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ40) | 1 year |
| muscle power | based on Muscle Manual Test (MMT) | 1 year |
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D016298 |
| Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |