Randomized, Placebo-Controlled Study of Tolcapone in Patients With Fluctuating Parkinson Disease Treated With Levodopa-Carbidopa

Abstract

Tolcapone was well tolerated and substantially increased on time and reduced off time in patients with fluctuating Parkinson disease. Additionally, levodopa requirements were significantly decreased.

Association of adverse effects with monoamine oxidase type B inhibitor and catechol-o-methyl transferase inhibitor combination therapy in Parkinson’s disease patients

“…Both COMTI and MAOBI combination regimens with levodopa have been found to reduce "off" time and motor fluctuations [8,[14][15][16][17][22][23][24]. Our study showed that COMTI subjects had a higher relative frequency of motor fluctuations with an OR of 2.2 in the single variable model (95% CI: 0.9 to 5.1).…”

Association of adverse effects with monoamine oxidase type B inhibitor and catechol-o-methyl transferase inhibitor combination therapy in Parkinson’s disease patients

“…Both COMTI and MAOBI combination regimens with levodopa have been found to reduce "off" time and motor fluctuations [8,[14][15][16][17][22][23][24]. Our study showed that COMTI subjects had a higher relative frequency of motor fluctuations with an OR of 2.2 in the single variable model (95% CI: 0.9 to 5.1).…”

Entacapone is beneficial in both fluctuating and non-fluctuating patients with Parkinson's disease: a randomised, placebo controlled, double blind, six month study

“…[28][29][30][31] The results are also in accordance with phase III tolcapone studies in fluctuating patients. [31][32][33][34][35][36][37] In the present study, the daily ON time was significantly improved by 1.2 hours, and the OFF time correspondingly reduced, with entacapone compared with placebo. This was despite apparent individual optimisation of the levodopa and other antiparkinsonian drug treatment before entry to the trial.…”

Utility of tolcapone in fluctuating Parkinson's disease

“…However gait analysis did not confirm these findings in this trial. Secondary analyses of other UPDRS subscales of total scores in the above studies did not demonstrate statistically significant improvements over placebo (Kurth et al 1997; Myllyla et al 1997; Rajput et al 1997; Adler et al 1998; Shan et al 2001). Other secondary analysis of health-related quality of life found an improvement in one study (Baas et al 1997), but not another (Adler et al 1998).…”

Association of adverse effects with monoamine oxidase type B inhibitor and catechol-o-methyl transferase inhibitor combination therapy in Parkinson’s disease patients

“…Both COMTI and MAOBI combination regimens with levodopa have been found to reduce "off" time and motor fluctuations [8,[14][15][16][17][22][23][24]. Our study showed that COMTI subjects had a higher relative frequency of motor fluctuations with an OR of 2.2 in the single variable model (95% CI: 0.9 to 5.1).…”

Entacapone is beneficial in both fluctuating and non-fluctuating patients with Parkinson's disease: a randomised, placebo controlled, double blind, six month study

“…[28][29][30][31] The results are also in accordance with phase III tolcapone studies in fluctuating patients. [31][32][33][34][35][36][37] In the present study, the daily ON time was significantly improved by 1.2 hours, and the OFF time correspondingly reduced, with entacapone compared with placebo. This was despite apparent individual optimisation of the levodopa and other antiparkinsonian drug treatment before entry to the trial.…”

Utility of tolcapone in fluctuating Parkinson's disease

“…However gait analysis did not confirm these findings in this trial. Secondary analyses of other UPDRS subscales of total scores in the above studies did not demonstrate statistically significant improvements over placebo (Kurth et al 1997; Myllyla et al 1997; Rajput et al 1997; Adler et al 1998; Shan et al 2001). Other secondary analysis of health-related quality of life found an improvement in one study (Baas et al 1997), but not another (Adler et al 1998).…”

Association of adverse effects with monoamine oxidase type B inhibitor and catechol-o-methyl transferase inhibitor combination therapy in Parkinson’s disease patients

“…Both COMTI and MAOBI combination regimens with levodopa have been found to reduce "off" time and motor fluctuations [8,[14][15][16][17][22][23][24]. Our study showed that COMTI subjects had a higher relative frequency of motor fluctuations with an OR of 2.2 in the single variable model (95% CI: 0.9 to 5.1).…”

Entacapone is beneficial in both fluctuating and non-fluctuating patients with Parkinson's disease: a randomised, placebo controlled, double blind, six month study

“…[28][29][30][31] The results are also in accordance with phase III tolcapone studies in fluctuating patients. [31][32][33][34][35][36][37] In the present study, the daily ON time was significantly improved by 1.2 hours, and the OFF time correspondingly reduced, with entacapone compared with placebo. This was despite apparent individual optimisation of the levodopa and other antiparkinsonian drug treatment before entry to the trial.…”

Utility of tolcapone in fluctuating Parkinson's disease

“…However gait analysis did not confirm these findings in this trial. Secondary analyses of other UPDRS subscales of total scores in the above studies did not demonstrate statistically significant improvements over placebo (Kurth et al 1997; Myllyla et al 1997; Rajput et al 1997; Adler et al 1998; Shan et al 2001). Other secondary analysis of health-related quality of life found an improvement in one study (Baas et al 1997), but not another (Adler et al 1998).…”