Status:
COMPLETED
G-CSF Treatment for Amyotrophic Lateral Sclerosis: A RCT Study Assessing Clinical Response
Lead Sponsor:
Peking University
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This study will examine the effectiveness of G-CSF in treating patients with amyotrophic lateral sclerosis (ALS) - a fatal neurological degenerative disease that causes adult-onset, progressive motor ...
Eligibility Criteria
Inclusion
- All subjects must have a verifiable diagnosis of ALS of 0.5 to 2 years' duration. The diagnosis must be supported by the Revised Criteria of the World Federation of Neurology. The grades of diagnosis must be clinically definite ALS or clinically probable ALS.
- All subjects must be over age 18 and below 65.
- The ALS is mildly to moderate based on ALS Health State Scale.
- Electrophysiological features show CMAP amplitude of motor nerve normal or mild declining.
- Serum creatine kinase is normal or mild upper, less than 500U/L.
Exclusion
- If anyone of the above eligibility requirements is not met
- Use of any other investigational agent within 30 days beginning the treatment phase of this study
- Severe cardiac, pulmonary, hepatic or/and hematic disease
- HIV positivity or signs and symptoms consistent with HIV infection
- Pregnant or nursing women
- History of cancer with less than 5 years documentation of a disease-free state
- History of anaphylactic reaction or hypersensitivity to G-CSF or proteins derived from E.coli
- Alcohol or drug abuse in recent 1 year
- Can't understand or obey the rules of treatment
- Blood donor in recent 30 days
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00397423
Start Date
December 1 2006
End Date
August 1 2007
Last Update
November 28 2007
Active Locations (1)
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1
Dongsheng Fan
Beijing, Beijing Municipality, China, 100083