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Efficacy and safety of co-careldopa as an add-on therapy to occupational and physical therapy in patients after stroke (DARS): a randomised, double-blind, placebo controlled trial

Ford, Gary A.; Bhakta, Bipin B.; Cozens, Alastair; Hartley, Suzanne; Holloway, Ivana; Meads, David; Pearn, John; Ruddock, Sharon; Sackley, Catherine M.; Saloniki, Eirini-Christina; Santorelli, Gillian; Walker, Marion F.; Farrin, Amanda J.; Ford, Gary A.

Authors

Gary A. Ford gary.ford@ouh.nhs.uk

Bipin B. Bhakta

Alastair Cozens

Suzanne Hartley

Ivana Holloway

David Meads

John Pearn

Sharon Ruddock

Catherine M. Sackley

Eirini-Christina Saloniki

Gillian Santorelli

Marion F. Walker

Amanda J. Farrin

Gary A. Ford



Abstract

Background: Dopamine is a key modulator of striatal function and learning and may improve motor recovery after stroke. Previous small trials of dopamine agonists after stroke provide equivocal evidence of effectiveness on improving motor recovery.
Methods: This double blind, multi-centre, randomised controlled trial of co-careldopa versus placebo in addition to routine NHS occupational and physical therapy was done at UK NHS Stroke Services. We recruited stroke patients who were unable to walk 10 metres or more. Participants were randomised (1:1) to receive six weeks of co-careldopa or placebo taken 45-60 minutes before rehabilitation that included motor activities. The primary outcome was ability to walk independently at eight weeks assessed by Rivermead Mobility Index score of ≥7. Primary and safety analyses were done in the intention-to-treat population. The trial is registered ISRCTN99643613
Findings: Between May 2011 to March 2014, 593 patients (mean age 68·5 years; 308 patients co-careldopa, 285 placebo), were recruited on average 18 days following stroke onset. Primary outcome data were available for all 593. There was no evidence that ability to walk independently improved (125/308 [40·6%] co-careldopa vs 127/285 [44·6%] placebo; odds ratio 0·78, 95% confidence interval (CI) 0·53, 1·15) at eight weeks not at six or 12 months. Mortality at 12 months was not significantly different (22 [7.1%] versus 17 [6·0%]). The most frequent adverse effect, vomiting during therapy sessions after study drug, was more frequent in the co-careldopa group (19 [6.2%] vs 9 [3.2%]).
Interpretation: Co-careldopa in addition to routine occupational and physical therapy does not improve walking following stroke. Further research is needed to identify sub-groups of stroke patients who might benefit from dopaminergic therapy at different doses or time after stroke with more intensive motor therapy.

Journal Article Type Article
Publication Date 1156
Print ISSN 0140-6736
Publisher Elsevier
Peer Reviewed Not Peer Reviewed
APA6 Citation Ford, G. A., Bhakta, B. B., Cozens, A., Hartley, S., Holloway, I., Meads, D., …Ford, G. A. (1156). Efficacy and safety of co-careldopa as an add-on therapy to occupational and physical therapy in patients after stroke (DARS): a randomised, double-blind, placebo controlled trial. Manuscript submitted for publication
Keywords Stroke; Rehabilitation; L-dopa; Mobility; Recovery; Double-blind; Placebo; RCT Authors Qualifications
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