The Effect of GCSF in the Treatment of ALS Patients

Amyotrophic Lateral Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01825551
• Other study ID #: 91-01-54-17265
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 13, 2013
• Last updated: November 10, 2013
• Start date: November 2012
• Est. completion date: November 2013

Study information

• Verified date: November 2013
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics CommitteeIran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

Drug:
• Granulocyte Colony Stimulating Factor

• Placebo

Locations

Country	Name	City	State
Iran, Islamic Republic of	Iranian Neurology Research Center of Tehran University of Medical Sciences	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	patient`s function	based on revised ALS Functional Rating scale (ALSFRS-r)	one year	No
Secondary	mobilizing bone marrow stem cells	based on cluster of differentiation 34 (CD34) and white blood cell (WBC) counting	1 year	Yes
Secondary	amplitude of compound muscle action potential in ulnar and peroneal nerve	based on compound muscle action potential (CMAP) measured in nerve conduction study	1 year	No
Secondary	quality of life	based on Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ40)	1 year	No
Secondary	muscle power	based on Muscle Manual Test (MMT)	1 year	No