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The Effect of GCSF in the Treatment of ALS Patients

Information source: Tehran University of Medical Sciences
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Amyotrophic Lateral Sclerosis

Intervention: Granulocyte Colony Stimulating Factor (Drug); Placebo (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Tehran University of Medical Sciences

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.

Clinical Details

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

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

Primary outcome: patient`s function

Secondary outcome:

mobilizing bone marrow stem cells

amplitude of compound muscle action potential in ulnar and peroneal nerve

quality of life

muscle power

Eligibility

Minimum age: 18 Years. Maximum age: 85 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

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

Starting date: November 2012
Last updated: November 10, 2013

Page last updated: August 23, 2015

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