The Effect of GCSF in the Treatment of ALS Patients

November 10, 2013 updated by: Tehran University of Medical Sciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
      • Tehran, Iran, Islamic Republic of
        • Iranian Neurology Research Center of Tehran University of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patient's function
Time Frame: one year
based on revised ALS Functional Rating scale (ALSFRS-r)
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mobilizing bone marrow stem cells
Time Frame: 1 year
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
Time Frame: 1 year
based on compound muscle action potential (CMAP) measured in nerve conduction study
1 year
quality of life
Time Frame: 1 year
based on Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ40)
1 year
muscle power
Time Frame: 1 year
based on Muscle Manual Test (MMT)
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tehran University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

March 13, 2013

First Submitted That Met QC Criteria

April 1, 2013

First Posted (Estimate)

April 5, 2013

Study Record Updates

Last Update Posted (Estimate)

November 13, 2013

Last Update Submitted That Met QC Criteria

November 10, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 91-01-54-17265

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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