Stroke with residual deficit
Conditions
Interventions
Trade Name: Filgrastim (Neupogen)
Product Name: FILGRASTIM
Product Code: 16216/0038
Pharmaceutical Form: Solution for injection
Pharmace
Sponsors
University of Nottingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adults (18 years and over) with motor impairment (arm or leg) with residual disability (modified Rankin Score >1) due to stroke >90 days post onset. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Lack of residual motor deficit; significant cognitive impairment that will impede ability to complete assessments, diagnosis likely to interfere with outcome or rehabilitation (e.g. terminal illness), still receiving post stroke rehabilitation; pregnancy; other exclusions of G-CSF (as per British National Formulary –see SmPC).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety, feasibility, and tolerability of delivering the drug G-CSF and or rehabilitation therapy in chronic stroke patients.;Secondary Objective: 1) To study potential interaction between the drug G-CSF and rehabilitation therapy in chronic stroke patients. 2) Finalise the design including the sample size calculations and outcome measures for the definitive trial, by obtaining information on functional measures, the spectrum of disability among trial recruits and the completeness of outcome data.;Primary end point(s): Feasibility: proportion of participants receiving all 5 G-CSF/placebo injections; proportion of participants receiving all therapy sessions. Acceptability- proportion of participants screened who are eligible for enrollment who give consent; Tolerability- Adverse events (headache, backache) reported after G-CSF adminisitration; proportion of participants who withdraw or decline rehabiliation therapy sessions. | — |
Countries
United Kingdom
Outcome results
None listed