MedDataX Logo

The Effect of GCSF in the Treatment of ALS Patients

NCT ID: NCT01825551

Last Updated: 2013-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2013-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Amyotrophic Lateral Sclerosis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Amyotrophic Lateral Sclerosis Granulocyte Colony Stimulating Factor

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Granulocyte Colony Stimulating Factor

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

Group Type ACTIVE_COMPARATOR

Granulocyte Colony Stimulating Factor

Intervention Type DRUG

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Granulocyte Colony Stimulating Factor

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Tehran University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Iranian Neurology Research Center of Tehran University of Medical Sciences

Tehran, Tehran Province, Iran

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Iran

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

91-01-54-17265

Identifier Type: -

Identifier Source: org_study_id