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Published Online
on June 11, 2009

Stroke. 2009
Published online before print June 11, 2009, doi: 10.1161/STROKEAHA.109.552075
A more recent version of this article appeared on September 1, 2009
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Right arrow Other Stroke Treatment - Medical

Submitted on March 10, 2009
Revised on April 20, 2009
Accepted on May 6, 2009

Randomized, Placebo-Controlled, Double-Blind Study of Ropinirole in Chronic Stroke

Steven C. Cramer MD*; Bruce H. Dobkin MD; Elizabeth A. Noser MD; Rachelle W. Rodriguez; and Lori A. Enney

From the Department of Neurology (S.C.C., R.W.R.), University of California, Irvine; Department of Neurology (B.H.D.), University of California, Los Angeles; Department of Neurology (E.A.N.), University of Texas, Houston; and Neurosciences MDC (L.A.E.), GlaxoSmithKline, Research Triangle Park, NC.

* To whom correspondence should be addressed. E-mail: scramer{at}uci.edu.

Background and Purpose—Evidence suggests the potential to improve motor status in patients with stroke by modifying brain catecholaminergic tone. The current study hypothesized that increased dopaminergic tone via the dopamine agonist ropinirole, when combined with physiotherapy (PT), would significantly and safely increase gait velocity.

Methods—Patients with moderate motor deficits due to stroke 1 to 12 months prior were randomized (double blinded) to 9 weeks of immediate-release ropinirole or placebo, each with PT, and followed up for 3 additional weeks. Drug dose (0.25 to 4 mg once daily) was titrated weekly, as tolerated. The primary end point was gait velocity during the 12 weeks of study participation.

Results—Patients in the ropinirole+PT group averaged 2.4 mg/d by end of week 9, although the target dose was at least 3 mg/d. Ropinirole+PT was generally safe and well tolerated, including no drug-related serious adverse events. Across all 33 enrollees, significant gains were found over time for gait velocity and for most secondary end points. However, gains did not differ by treatment assignment. PT and occupational therapy were commonly prescribed outside of the trial, although the extent of these was not correlated with study outcomes.

Conclusions—At doses achieved in this trial, increased dopaminergic tone via ropinirole+PT was generally well tolerated but did not show any improvement over and above the effects of PT alone.


Key words: stroke treatment • stroke recovery