NCT01825551

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2013

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 5, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

November 13, 2013

Status Verified

November 1, 2013

Enrollment Period

1 year

First QC Date

March 13, 2013

Last Update Submit

November 10, 2013

Conditions

Amyotrophic Lateral Sclerosis

Keywords

Amyotrophic Lateral SclerosisGranulocyte Colony Stimulating Factor

Outcome Measures

Primary Outcomes (1)

  • patient's function

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

    one year

Secondary Outcomes (4)

  • mobilizing bone marrow stem cells

    1 year

  • amplitude of compound muscle action potential in ulnar and peroneal nerve

    1 year

  • quality of life

    1 year

  • muscle power

    1 year

Study Arms (2)

Granulocyte Colony Stimulating Factor

ACTIVE COMPARATOR

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

Drug: Granulocyte Colony Stimulating Factor

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Granulocyte Colony Stimulating FactorDRUG
Granulocyte Colony Stimulating Factor
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Iranian Neurology Research Center of Tehran University of Medical Sciences

Tehran, Tehran Province, Iran

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Granulocyte Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2013

First Posted

April 5, 2013

Study Start

November 1, 2012

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

November 13, 2013

Record last verified: 2013-11

Locations

IR(1)