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Completed

NCT Number: NCT01825551

The Effect of GCSF in the Treatment of ALS Patients

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.

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Key information

Conditions

Amyotrophic Lateral Sclerosis Central Nervous System Diseases Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Iranian Neurology Research Center of Tehran University of Medical Sciences

Tehran, Tehran Province, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Granulocyte Colony Stimulating Factor

Drug

Placebo

Drug

Primary outcomes

  1. patient's function

    Time frame: one year

    based on revised ALS Functional Rating scale (ALSFRS-r)

Secondary outcomes

  1. mobilizing bone marrow stem cells

    Time frame: 1 year

    based on cluster of differentiation 34 (CD34) and white blood cell (WBC) counting

  2. amplitude of compound muscle action potential in ulnar and peroneal nerve

    Time frame: 1 year

    based on compound muscle action potential (CMAP) measured in nerve conduction study

  3. quality of life

    Time frame: 1 year

    based on Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ40)

  4. muscle power

    Time frame: 1 year

    based on Muscle Manual Test (MMT)

Sponsors and collaborators

Lead sponsor

Tehran University of Medical Sciences

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 5, 2013
Registry last updated
Nov 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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