The Effect of GCSF in the Treatment of ALS Patients

Tehran University of Medical Sciences

Status and phase: Completed; Phase 3; Phase 2

Conditions: Amyotrophic Lateral Sclerosis

Treatments: Drug: Granulocyte Colony Stimulating Factor; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01825551

91-01-54-17265

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

Granulocyte Colony Stimulating Factor

Active Comparator group

Description:

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

Treatment:

Drug: Granulocyte Colony Stimulating Factor

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo