Stroke Circulatory System Stroke, not specified as haemorrhage or infarction
Conditions
Interventions
Current interventions as of 12/02/2013:
572 participants with stroke will be randomised to receive Co-careldopa or placebo within 5 ? 42 days post stroke.
Experimental
Sponsors
University of Leeds (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 12/02/2013: Patients meeting all of the following criteria are eligible for trial entry. It is possible that a patient?s condition may change during the 5 to 42 days post stroke and the patient must be reviewed during this period to assess eligibility: 1. New or recurrent clinically diagnosed ischaemic or haemorrhagic (excluding subarachnoid haemorrhage) stroke within 5 to 42 days prior to randomisation. 2. Cannot walk 10 metres or more indoors independently (i.e. without use of physical assistance) 3. Professionally scored Rivermead Mobility Index score of <7. 4. Expected to need rehabilitation treatment 5. Aged 18 years or above 6. Able to give informed consent 7. Able to access continuity of rehabilitation treatment following discharge from hospital. This can be through early supported discharge scheme or hospital/community therapy according to local practice. It is important that continuity of rehabilitation is available within 5 days following discharge. 8. Expected to be able to comply with treatment schedule (e.g. swallow whole tablets) 9. Expected to be in hospital for at least their first two doses trial medication Inclusion criterion numbers 6, 8 and other co-morbidities should be monitored up to 42 days post stroke as patients initially not meeting the eligibility criteria might improve and therefore meet the eligibility criteria within the 42 day post stroke period. Previous inclusion criteria as of 23/03/2010 and until 12/02/2013: Points 1 and 2 below have been amended to read as follows: 1. New clinically diagnosed ischaemic or haemorrhagic stroke (excluding subarachnoid haemorrhage) stroke in the 2 weeks prior to randomisation 2. Cannot walk 10 metres without assistance All other points remain the same. Current information as of 10/03/2010: 1. New clinically diagnosed ischaemic or haemorrhagic stroke 2. Cannot walk two metres 3. Expected to need ongoing rehabilitation treatment after randomisation 4. Aged 18 years or above, either sex 5. Able to give informed consent 6. Able to access continuity of rehabilitation treatment following discharge from hospital 7. Expected to comply with treatment schedule post-randomisation Initial information at time of registration: 1. New stroke in the previous 2 weeks 2. Aged 18 years or above, either sex 3. Able to give informed consent 4. Rivermead Mobility Index (RMI) score less than 7 (corresponds to No to the question "Can you walk 10 metres with an aid if necessary but with no standby help"). This provides a robust approach to defining participants for inclusion and would reflect the types of patients where this approach would be used if it was found to be effective.
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 12/02/2013: Patients meeting any of the following criteria are not eligible for trial entry: 1. Not expected to survive for 2 months following stroke 2. Diagnosis of Parkinson?s disease, severe medical or surgical illness, severe psychosis 3. Known hypersensitivity or contraindications to Co-careldopa (Please refer to the trial supplied Summary of Product Characteristics (SmPC)) 4. Symptomatic orthostatic hypotension 5. Needed physical assistance of at least one person to walk prior to stroke due to pre-existing co-morbidities (e.g. heart failure, osteoarthritis) 6. Pregnancy, lactation or women of child-bearing potential unwilling to use medically approved contraception whilst receiving treatment and for 1 month after treatment has finished 7. Patients currently participating in other interventional drug or treatment therapy trials* 8. Could not walk 10 metres or more indoors prior to their stroke (may have used a walking aid if necessary, but required no physical assistance). In this context physical assistance means help from one or more persons *Enrollment of a trial participant in another trial will not necessarily exclude a patient from participating in the DARS trial. Potential trials for co-enrollment with DARS are considered by the Chief Investigator and Trial Management team with regards to: 1. It has been agreed with the Chief Investigator of the relevant studies. 2. It does not confound the results of DARS 3. It does not overburden the patient, 4. Attribution of causality to adverse events is not compromised 5. There are no potential interactions Previous exclusion criteria as of 10/03/2010 and until 12/02/2013: 1. Not expected to survive 2 months following stroke 2. Diagnosis of Parkinson?s disease, dementia, severe systemic illness, severe psychosis or glaucoma 3. Known hypersensitivity to co-careldopa 4. Patients taking monoamine oxidase inhibitors, dopaminergic or sympathomimetic agents 5. Symptomatic postural hypotension 6. Need physical assistance of at least one person to walk prior to stroke due to pre-existing co-morbidities (e.g. heart failure, osteoarthritis) 7. Pregnancy/lactation or women of child bearing potential unwilling to use medically approved contraception whilst receiving treatment Initial information at time of registration: 1. Unlikely to survive for more than 1 month 2. Requiring palliative care as assessed by the treating physician 3. Parkinson's disease 4. Contraindications to L-dopa (such as glaucoma, cardiac arrhythmias, severe psychotic disorders, active peptic ulcer disease) 5. Symptomatic postural hypotension 6. Taking sympathomimetic agents 7. Unable to walk prior to stroke due to pre-existing co-morbidities (e.g. heart failure, osteoarthritis)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 12/02/2013: The proportion of participants walking as defined by a score of 7 or above on the Rivermead Mobility Index (RMI), in the Co-careldopa and control intervention groups. This is a robust unambiguous clinical cut off indicator of Co-careldopa effect as it defines clearly the proportion of those walking at least 10 metres without assistance from another person, in the active and control groups at the primary end point (8 weeks) and the secondary end points (6, 12 months). The RMI has been validated and extensively used in clinical studies. Previous primary outcome measures until 12/02/2013: The proportion of participants walking as defined by a score of 7 or above on the Rivermead Mobility Index (RMI), in the L-dopa and control intervention groups. This is a robust unambiguous clinical cut off indicator of L-dopa effect as it defines clearly the proportion of those walking at least 10 metres without assistance from another person, in the active and control groups at the primary end point (8 weeks) and the secondary end points (6, 12 months). The RMI has been validated and extensively used in clinical studies. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 12/02/2013: 1. Barthel Index - a widely used and validated scale, scored from 0 - 20, that measures self care dependency in stroke 2. Nottingham Extended Activities of Daily Living Scale (validated and sensitive to change, used to measure instrumental activities of daily living such as outdoor mobility and household tasks) 3. General Health Questionnaire 12, a widely used questionnaire to measure depression in clinical trials 4. Caregiver Burden Index (we anticipate that improved physical recovery would reduce carers strain, this is a validated measure of carer strain and has been used in stroke clinical trials) 5. EQ-5D (a widely used measure of health status for economic evaluation) 6. A standardised proforma will be developed to capture the patient and therapists perspective of the use of Co-careldopa as part of the rehabilitation treatment (including issues relating to adherence to timing of Co-careldopa treatment as well as the type of rehabilitation treatment given 7. Modified Rankin Scale will be used so that results form this study can be related to other clinical trials (see National Stroke Trials database initiative) 8. Changes on the RMI can also capture changes in posture and movement. The RMI has 15 items that measure the ability of patients to make postural adjustments (e.g. move in bed), transfer (e.g. between bed to chair, chair to toilet) and walk (indoors and outdoors) and it scored from 0 - 15. We will analyse RMI change score which, as an indicator of the effect of Co-careldopa on overall posture and movement of patients undergoing stroke rehabilitation 9. We will collect data on lesion location identified from routinely undertaken Brain CT scans at time of admission to stroke unit. All people with acute stroke should have a CT Brain scan on admission to identify p | — |
Countries
United Kingdom
Outcome results
None listed