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The FDA approval of Nourianz is based on findings from randomized, multi-center, double-blind, placebo-controlled trials in patients with PD taking a stable dose of levodopa/carbidopa with or without other PD medications.
The effectiveness of the product in treating 'off' episodes in patients with Parkinson's disease who are already being treated with levodopa/carbidopa was indicated in four 12-week placebo-controlled clinical studies that included a total of 1,143 participants.
The effectiveness of Nourianz in treating 'off' episodes in patients with PD who are already being treated with levodopa/carbidopa was shown in four 12-week placebo-controlled clinical studies that included a total of 1,143 participants.
Data from four 12-week placebo-controlled clinical studies demonstrated the effectiveness of Nourianz, a selective adenosine A2A receptor antagonist, in treating "off" episodes in 1,143 PD patients who were receiving treatment with levodopa/carbidopa. Compared with patients who received placebo, patients who received Nourianz experienced a statistically significant decrease in daily "off" time from baseline.
Linazasoro et al., "Efficacy of levodopa/carbidopa/entacapone versus levodopa/carbidopa in patients with early Parkinson's disease experiencing mild wearing-off: a randomised, double-blind trial," Journal of Neural Transmission, vol.
patients with Parkinson's disease (PD) currently taking levodopa/carbidopa and experiencing "off" episodes.
Levodopa/carbidopa is the most commonly prescribed medication for Parkinson's disease.
Sinemet (levodopa/carbidopa) is a first-line treatment for Parkinson's disease.
For these patients, levodopa/carbidopa may be used (Novak et al., 2006).
Entacapone (Comtan) has been approved by the Food and Drug Adminis tration for use in the treatment of Parkinson's disease as an adjunct to levodopa/carbidopa therapy.
The drug was approved as Tasmar in January 1998 for adjunctive use in patients whose Parkinson's symptoms are not adequately controlled despite being on adequate doses of levodopa/carbidopa, according to the FDA.
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