Je. Ahlskog et al., ADJUNCTIVE CABERGOLINE THERAPY OF PARKINSONS-DISEASE - COMPARISON WITH PLACEBO AND ASSESSMENT OF DOSE RESPONSES AND DURATION OF EFFECT, Clinical neuropharmacology, 19(3), 1996, pp. 202-212
Adjunctive cabergoline or placebo, in doses up to 5 mg daily, were adm
inistered to Parkinson's disease patients with short-duration levodopa
responses in a 6-month double-blind trial. The 13 patients randomized
to cabergoline and completing the study had significantly improved Un
ified Parkinson's Disease Rating Scale (UPDRS) motor scores and timed
hand-tapping test scores. Serial measurements on test days documented
improved scores: (a) before the first levodopa (and cabergoline) dose
of the day, (b) at the time of the peak levodopa effect, and (c) at th
e end of the levodopa response cycle, 5 h after test doses, Continued
testing verified that these therapeutic responses were sustained for a
t least 48 h after the last cabergoline dose, Patients randomized to p
lacebo failed to improve on any of these measures. In a subsequent ope
n-label dose-escalation phase, further improvement was documented as t
he dosage was gradually raised to 10 mg daily. As in the double-blind
phase, levodopa reduction allowed the improvement to occur in the abse
nce of significantly increased dyskinesias. Other side effects were mo
re substantial with higher doses, however, including two of 11 patient
s with hallucinations and confusion. In summary, adjunctive single-dai
ly-dose cabergoline therapy resulted in long-lasting, dose-related imp
rovement in parkinsonism not seen in patients receiving placebo.