Randomized, placebo-controlled, double-blind study of ropinirole in chronic stroke.
OBJECTIVE
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.
Cramer
Steven C
SC
Department of Neurology, University of California, Irvine, USA. scramer@uci.edu
Dobkin
Bruce H
BH
Noser
Elizabeth A
EA
Rodriguez
Rachelle W
RW
Enney
Lori A
LA
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002908:Chronic Disease; D018491:Dopamine Agonists / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D005684:Gait / Q000187:drug effects*; D006801:Humans; D007211:Indoles / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D026741:Physical Therapy Modalities; D020521:Stroke / Q000628:therapy*; D013997:Time Factors
D018491:Dopamine Agonists; D007211:Indoles; C046649:ropinirole