Study to Determine The Effect of a Drug Called Neupogen on Stroke Recovery

NCT00809549 | Unknown Phase 1 DMC

• 1 other identifier: 2006076-01H
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

1. 1.Circulating bone marrow and blood vessel precursors home in to sites of ischemia and aid regeneration of injured tissue
2. 2.Increasing the number of circulating precursors will improve in regeneration of damaged brain following ischemic stroke.

Conditions

Ischemic Stroke

Keywords

Stroke; GCSF; Hematopoeitic; Neupogen; Filgrastim

Outcome Measures

Primary Outcomes (1)

• A statistically significant increase in: mortality/ non-fatal grade III or greater adverse events measured by the NCI Common Toxicity Scale/ incidence of recurrent strokes/ worsening of neurological disabilities measured by standardized stroke scales.

  6 weeks, 3 months, 6 months and 12 months after the first dose of the study drug.

Secondary Outcomes (1)

• The secondary endpoints address the feasibility and efficacy of the study treatment: adequacy of bone marrow cell mobilization/ validation of imaging sequences/ Identification of optimal parameters for follow-up to be used in a subsequent larger trial.

  6 weeks, 3 months, 6 months and 12 months after the first dose of the study drug.

Study Arms (2)

Normal Saline

PLACEBO COMPARATOR

Drug: Filgrastim

Filgrastim

EXPERIMENTAL

Drug: Filgrastim

Interventions

Filgrastim DRUG

10 ug/kg sc once daily x 4 days. Repeated once, 6 weeks later.

Also known as: Brand Name: Neupogen, rhG-CSF

Filgrastim; Normal Saline

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is between 45 and 85 years of age
• Patient is of either gender
• The qualifying stroke is ischemic with a total NIH Stroke Score less than 18.
• The stroke is classified as a partial anterior cerebral syndrome by the Oxfordshire Criteria.
• NIHSS at baseline evaluation with:
• \*Level of consciousness is not impaired as defined by an NIHSS between 0 and 1 on question 1a and
• Hemiparesis as defined by
• an NIHSS between 1 and 4 on questions 5 and/or
• an NIHSS between 1 and 4 on questions 6.
• Be able to start the experimental treatment a minimum of 3 days and a maximum of 10 days after the initial presentation with the stroke,
• Patient or surrogate gives informed consent,
• The patient is fluent in either French or English.

You may not qualify if:

• Patient with hemorrhagic stroke,
• Patients with a pre-morbid modified Rankin score \> 2 (Appendix 3b),
• Patients with pre-morbid dementia by DSM-IV criteria.
• Patients with a known allergic reaction to G-CSF or a component of G-CSF.
• Patients with one or more significant co-morbidities expected to limit lifespan to less than 12 months. Examples include but are not limited to:
• \> CHF Class II NYHA
• Known prior or ongoing malignancy except non-melanomatous skin cancer.
• Acute or chronic infections (HIV, TB, etc.. )
• Other significant cardiac, renal, hepatic or pulmonary dysfunction.
• Patients with organ dysfunction that would preclude tests required for this study. Examples include but are not limited to:
• \*Serum Cr \> 200 μmol/L that would prevent administration of contrast dye.
• Patients with a known history of bone marrow dysfunction, such as myeloid leukemia or myeloproliferative state that would prevent treatment with G-CSF.
• Patients with metal implants that would preclude MRI examination including but not limited to patients with
• pacemakers,
• ear implants, and

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (2)

The Ottawa Hospital

Ottawa, Ontario, K1Y 4E9, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Ischemic Stroke; Stroke

Interventions

Filgrastim; pegylated granulocyte colony-stimulating factor

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Michael Sharma, MD

  The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2008
• First Posted: December 17, 2008
• Study Start: July 1, 2006
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: July 13, 2012

Record last verified: 2012-07

Locations

CA (2)