The Effect of GCSF in the Treatment of ALS Patients

Phase 2

Completed

• Conditions: Amyotrophic Lateral Sclerosis
• Interventions: Drug: Placebo; Drug: Granulocyte Colony Stimulating Factor

• Registration Number: NCT01825551
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2013-03-13
• Study First Submitted QC: 2013-04-01
• Study First Posted: 2013-04-05
• Status Verified: 2013-11
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Last Update Submitted: 2013-11-10
• Last Update Posted: 2013-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	normal saline 0.01 ml/kg/day for 5 days subcutaneously
Granulocyte Colony Stimulating Factor	Granulocyte Colony Stimulating Factor	Granulocyte Colony Stimulating Factor 10 microgram/ kg/ day for 5 days subcutaneously

Primary Outcome Measures

Name	Time	Method
patient's function	one year	based on revised ALS Functional Rating scale (ALSFRS-r)

Secondary Outcome Measures

Name	Time	Method
muscle power	1 year	based on Muscle Manual Test (MMT)
mobilizing bone marrow stem cells	1 year	based on cluster of differentiation 34 (CD34) and white blood cell (WBC) counting
amplitude of compound muscle action potential in ulnar and peroneal nerve	1 year	based on compound muscle action potential (CMAP) measured in nerve conduction study
quality of life	1 year	based on Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ40)

Trial Locations

Locations (1)

Iranian Neurology Research Center of Tehran University of Medical Sciences; 🇮🇷 Tehran, Iran, Islamic Republic of