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The Effect of GCSF in the Treatment of ALS Patients

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ClinicalTrials.gov Identifier: NCT01825551
Recruitment Status : Completed
First Posted : April 5, 2013
Last Update Posted : November 13, 2013
Sponsor:
Information provided by (Responsible Party):
Tehran University of Medical Sciences

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Drug: Granulocyte Colony Stimulating Factor Drug: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Granulocyte Colony Stimulating Factor (GCSF) in the Treatment of Amyotrophic Lateral Sclerosis (ALS) Patients Referred to Tehran Imam Khomeini and Shariati Hospital Centers in 2013
Study Start Date : November 2012
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013


Arm Intervention/treatment
Active Comparator: Granulocyte Colony Stimulating Factor
Granulocyte Colony Stimulating Factor 10 microgram/ kg/ day for 5 days subcutaneously
Drug: Granulocyte Colony Stimulating Factor
Placebo Comparator: Placebo
normal saline 0.01 ml/kg/day for 5 days subcutaneously
Drug: Placebo



Primary Outcome Measures :
  1. patient`s function [ Time Frame: one year ]
    based on revised ALS Functional Rating scale (ALSFRS-r)


Secondary Outcome Measures :
  1. mobilizing bone marrow stem cells [ Time Frame: 1 year ]
    based on cluster of differentiation 34 (CD34) and white blood cell (WBC) counting

  2. amplitude of compound muscle action potential in ulnar and peroneal nerve [ Time Frame: 1 year ]
    based on compound muscle action potential (CMAP) measured in nerve conduction study

  3. quality of life [ Time Frame: 1 year ]
    based on Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ40)

  4. muscle power [ Time Frame: 1 year ]
    based on Muscle Manual Test (MMT)



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age between 18 and 85
  • definite or probable ALS according to revised El Escorial criteria
  • maximum 2 years from initiation of symptoms to study entry
  • mild to moderate disability according to revised ALS functional rating scale (ALSFRS-r)

Exclusion Criteria:

  • familial ALS
  • pregnancy or lactation
  • myeloproliferative or hematologic disorders
  • active immunological disease
  • liver or renal or heart disease
  • HIV positive
  • significant cognitive disorder
  • hypersensitivity to GCSF

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): NCT01825551


Locations
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Iran, Islamic Republic of
Iranian Neurology Research Center of Tehran University of Medical Sciences
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Tehran University of Medical Sciences

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Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01825551     History of Changes
Other Study ID Numbers: 91-01-54-17265
First Posted: April 5, 2013    Key Record Dates
Last Update Posted: November 13, 2013
Last Verified: November 2013
Keywords provided by Tehran University of Medical Sciences:
Amyotrophic Lateral Sclerosis
Granulocyte Colony Stimulating Factor
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
Sargramostim
Lenograstim
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic