G-CSF Treatment for Amyotrophic Lateral Sclerosis: A RCT Study Assessing Clinical Response

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00397423
• Date of registration: 08/11/2006
• Prospective Registration: Yes
• Primary sponsor: Peking University
• Public title: G-CSF Treatment for Amyotrophic Lateral Sclerosis: A RCT Study Assessing Clinical Response
• Scientific title: Granulocyte-Colony Stimulating Factor Treatment for Amyotrophic Lateral Sclerosis: A Randomized Control Trial Study Assessing Clinical Response
• Date of first enrolment: December 2006
• Target sample size: 40
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00397423
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

China

Contacts

• Name: Dongsheng Fan, MD
• Affiliation: Peking University Third Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Amyotrophic Lateral Sclerosis

Intervention(s)

Drug: NS

Drug: Granulocyte Colony Stimulating Factor

Primary Outcome(s)

the mean rate of decline of ALS-FRS score [Time Frame: 12 months]

Secondary Outcome(s)

the mean rate decline of the AARS score [Time Frame: 12 months]

Secondary ID(s)

R01-123456-1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors