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The Effect of GCSF in the Treatment of ALS Patients

Primary Purpose

Amyotrophic Lateral Sclerosis

Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Granulocyte Colony Stimulating Factor
Placebo
Sponsored by
Tehran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amyotrophic Lateral Sclerosis focused on measuring Amyotrophic Lateral Sclerosis, Granulocyte Colony Stimulating Factor

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Iranian Neurology Research Center of Tehran University of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Granulocyte Colony Stimulating Factor

Placebo

Arm Description

Granulocyte Colony Stimulating Factor 10 microgram/ kg/ day for 5 days subcutaneously

normal saline 0.01 ml/kg/day for 5 days subcutaneously

Outcomes

Primary Outcome Measures

patient's function
based on revised ALS Functional Rating scale (ALSFRS-r)

Secondary Outcome Measures

mobilizing bone marrow stem cells
based on cluster of differentiation 34 (CD34) and white blood cell (WBC) counting
amplitude of compound muscle action potential in ulnar and peroneal nerve
based on compound muscle action potential (CMAP) measured in nerve conduction study
quality of life
based on Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ40)
muscle power
based on Muscle Manual Test (MMT)

Full Information

First Posted
March 13, 2013
Last Updated
November 10, 2013
Sponsor
Tehran University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01825551
Brief Title
The Effect of GCSF in the Treatment of ALS Patients
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 Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tehran University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis
Keywords
Amyotrophic Lateral Sclerosis, Granulocyte Colony Stimulating Factor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Granulocyte Colony Stimulating Factor
Arm Type
Active Comparator
Arm Description
Granulocyte Colony Stimulating Factor 10 microgram/ kg/ day for 5 days subcutaneously
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
normal saline 0.01 ml/kg/day for 5 days subcutaneously
Intervention Type
Drug
Intervention Name(s)
Granulocyte Colony Stimulating Factor
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
patient's function
Description
based on revised ALS Functional Rating scale (ALSFRS-r)
Time Frame
one year
Secondary Outcome Measure Information:
Title
mobilizing bone marrow stem cells
Description
based on cluster of differentiation 34 (CD34) and white blood cell (WBC) counting
Time Frame
1 year
Title
amplitude of compound muscle action potential in ulnar and peroneal nerve
Description
based on compound muscle action potential (CMAP) measured in nerve conduction study
Time Frame
1 year
Title
quality of life
Description
based on Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ40)
Time Frame
1 year
Title
muscle power
Description
based on Muscle Manual Test (MMT)
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Iranian Neurology Research Center of Tehran University of Medical Sciences
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

The Effect of GCSF in the Treatment of ALS Patients

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