Completed

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

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What is being tested

Granulocyte Colony Stimulating Factor

+ Placebo

Drug
Who is being recruted

Central Nervous System Diseases+8

+ Metabolic Diseases

+ Nervous System Diseases

From 18 to 85 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2 & 3
Interventional
Study Start: November 2012
See protocol details

Summary

Principal SponsorTehran University of Medical Sciences
Last updated: November 13, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01825551
Principal SponsorTehran University of Medical Sciences
Last updated: November 13, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

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

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 85 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Central Nervous System DiseasesMetabolic DiseasesNervous System DiseasesNeuromuscular DiseasesNutritional and Metabolic DiseasesSpinal Cord DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesProteostasis DeficienciesTDP-43 ProteinopathiesAmyotrophic Lateral Sclerosis

Criteria

4 inclusion criteria required to participate
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)
8 exclusion criteria prevent from participating
HIV positive
active immunological disease
familial ALS
hypersensitivity to GCSF
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

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

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Iranian Neurology Research Center of Tehran University of Medical Sciences

Tehran, IranOpen Iranian Neurology Research Center of Tehran University of Medical Sciences in Google Maps
CompletedOne Study Center