A Controlled Trial of Rasagiline in Early Parkinson Disease

Abstract

Rasagiline is effective as monotherapy for patients with early PD. The 2 dosages in this trial were both effective relative to placebo. Further study is warranted to evaluate the longer-term effects of rasagiline in PD.

Long-term safety and efficacy of adjunctive rasagiline in levodopa-treated Japanese patients with Parkinson’s disease

“…This single-arm, open-label, phase 3 study is the first evaluation of the safety and efficacy of long-term rasagiline as adjunctive therapy in patients with PD who had wearing-off phenomena or weakened effect during treatment with levodopa. TEAEs were generally mild to moderate, in line with the findings of the previous studies of rasagiline (Parkinson Study Group 2002 , 2005 ; Rascol et al 2005 ). Fall and nasopharyngitis were the most frequently occurring TEAEs.…”

Long-term safety and efficacy of adjunctive rasagiline in levodopa-treated Japanese patients with Parkinson’s disease

“…This single-arm, open-label, phase 3 study is the first evaluation of the safety and efficacy of long-term rasagiline as adjunctive therapy in patients with PD who had wearing-off phenomena or weakened effect during treatment with levodopa. TEAEs were generally mild to moderate, in line with the findings of the previous studies of rasagiline (Parkinson Study Group 2002 , 2005 ; Rascol et al 2005 ). Fall and nasopharyngitis were the most frequently occurring TEAEs.…”

Long-term, open-label, phase 3 study of rasagiline in Japanese patients with early Parkinson’s disease

“…Consistent with previous studies (Parkinson Study Group 2002 ; Hauser et al 2009 ; Olanow et al 2009 ), monotherapy with 1 mg/day rasagiline improved the signs and symptoms of PD in Japanese patients, as assessed by MDS-UPDRS scores. At the end of rasagiline treatment, the MDS-UPDRS Part II + III total score improved from baseline (before rasagiline) by a mean of − 2.8 points in both groups.…”

“…Other than nasopharyngitis, all individual TEAEs occurred at an incidence < 10%, even over 52 weeks of rasagiline treatment. The type and frequency of TEAEs were similar to those reported in the TEMPO and ADAGIO studies (Parkinson Study Group 2002 , 2004 ; Olanow et al 2009 ; Lew et al 2010 ; Rascol et al 2016 ), indicating that there were no new safety issues or issues specific to Japanese patients. In the rasagiline 1 mg/day group of the TEMPO study, the incidence of adverse events was 79.5% during the first 26 weeks of treatment, and 66.4% during the subsequent 26 weeks of treatment (Parkinson Study Group 2004 ).…”

Efficacy and safety of rasagiline in Chinese patients with early Parkinson’s disease: a randomized, double-blind, parallel, placebo-controlled, fixed-dose study

“…The ratio of responders was also higher in the rasagiline group than in the placebo group (borderline significance), as was also reported in the TEMPO study [ 10 ]. This study found no significant effect of rasagiline on CGI-S and CGI-I.…”

“…In the primary efficacy analysis, the reduction in mean UPDRS total score was significantly greater in the rasagiline group (3.2 points) than in the placebo controls (0.2 points). This difference of 3 points was slightly lower than 4.2 points observed after 26 weeks monotherapy with 1 mg/day rasagiline in Caucasian patients in the TEMPO study [ 10 ] but comparable to that reported by the ADAGIO study of Caucasian people (3.01 point difference) but treated with 1 mg/d rasagiline for a longer study period of 36 weeks [ 11 ]. Notably, the TEMPO study enrolled patients whose disease severity was Hoehn and Yahr stage 3 or lower, whereas the ADAGIO study included subjects with stage 2.5 or lower, same as in the current study.…”

Long-term safety and efficacy of adjunctive rasagiline in levodopa-treated Japanese patients with Parkinson’s disease

“…This single-arm, open-label, phase 3 study is the first evaluation of the safety and efficacy of long-term rasagiline as adjunctive therapy in patients with PD who had wearing-off phenomena or weakened effect during treatment with levodopa. TEAEs were generally mild to moderate, in line with the findings of the previous studies of rasagiline (Parkinson Study Group 2002 , 2005 ; Rascol et al 2005 ). Fall and nasopharyngitis were the most frequently occurring TEAEs.…”

Long-term, open-label, phase 3 study of rasagiline in Japanese patients with early Parkinson’s disease

“…Consistent with previous studies (Parkinson Study Group 2002 ; Hauser et al 2009 ; Olanow et al 2009 ), monotherapy with 1 mg/day rasagiline improved the signs and symptoms of PD in Japanese patients, as assessed by MDS-UPDRS scores. At the end of rasagiline treatment, the MDS-UPDRS Part II + III total score improved from baseline (before rasagiline) by a mean of − 2.8 points in both groups.…”

“…Other than nasopharyngitis, all individual TEAEs occurred at an incidence < 10%, even over 52 weeks of rasagiline treatment. The type and frequency of TEAEs were similar to those reported in the TEMPO and ADAGIO studies (Parkinson Study Group 2002 , 2004 ; Olanow et al 2009 ; Lew et al 2010 ; Rascol et al 2016 ), indicating that there were no new safety issues or issues specific to Japanese patients. In the rasagiline 1 mg/day group of the TEMPO study, the incidence of adverse events was 79.5% during the first 26 weeks of treatment, and 66.4% during the subsequent 26 weeks of treatment (Parkinson Study Group 2004 ).…”

Efficacy and safety of rasagiline in Chinese patients with early Parkinson’s disease: a randomized, double-blind, parallel, placebo-controlled, fixed-dose study

“…The ratio of responders was also higher in the rasagiline group than in the placebo group (borderline significance), as was also reported in the TEMPO study [ 10 ]. This study found no significant effect of rasagiline on CGI-S and CGI-I.…”

“…In the primary efficacy analysis, the reduction in mean UPDRS total score was significantly greater in the rasagiline group (3.2 points) than in the placebo controls (0.2 points). This difference of 3 points was slightly lower than 4.2 points observed after 26 weeks monotherapy with 1 mg/day rasagiline in Caucasian patients in the TEMPO study [ 10 ] but comparable to that reported by the ADAGIO study of Caucasian people (3.01 point difference) but treated with 1 mg/d rasagiline for a longer study period of 36 weeks [ 11 ]. Notably, the TEMPO study enrolled patients whose disease severity was Hoehn and Yahr stage 3 or lower, whereas the ADAGIO study included subjects with stage 2.5 or lower, same as in the current study.…”

Long-term safety and efficacy of adjunctive rasagiline in levodopa-treated Japanese patients with Parkinson’s disease

“…This single-arm, open-label, phase 3 study is the first evaluation of the safety and efficacy of long-term rasagiline as adjunctive therapy in patients with PD who had wearing-off phenomena or weakened effect during treatment with levodopa. TEAEs were generally mild to moderate, in line with the findings of the previous studies of rasagiline (Parkinson Study Group 2002 , 2005 ; Rascol et al 2005 ). Fall and nasopharyngitis were the most frequently occurring TEAEs.…”

Long-term, open-label, phase 3 study of rasagiline in Japanese patients with early Parkinson’s disease

“…Consistent with previous studies (Parkinson Study Group 2002 ; Hauser et al 2009 ; Olanow et al 2009 ), monotherapy with 1 mg/day rasagiline improved the signs and symptoms of PD in Japanese patients, as assessed by MDS-UPDRS scores. At the end of rasagiline treatment, the MDS-UPDRS Part II + III total score improved from baseline (before rasagiline) by a mean of − 2.8 points in both groups.…”

“…Other than nasopharyngitis, all individual TEAEs occurred at an incidence < 10%, even over 52 weeks of rasagiline treatment. The type and frequency of TEAEs were similar to those reported in the TEMPO and ADAGIO studies (Parkinson Study Group 2002 , 2004 ; Olanow et al 2009 ; Lew et al 2010 ; Rascol et al 2016 ), indicating that there were no new safety issues or issues specific to Japanese patients. In the rasagiline 1 mg/day group of the TEMPO study, the incidence of adverse events was 79.5% during the first 26 weeks of treatment, and 66.4% during the subsequent 26 weeks of treatment (Parkinson Study Group 2004 ).…”

Efficacy and safety of rasagiline in Chinese patients with early Parkinson’s disease: a randomized, double-blind, parallel, placebo-controlled, fixed-dose study

“…The ratio of responders was also higher in the rasagiline group than in the placebo group (borderline significance), as was also reported in the TEMPO study [ 10 ]. This study found no significant effect of rasagiline on CGI-S and CGI-I.…”

“…In the primary efficacy analysis, the reduction in mean UPDRS total score was significantly greater in the rasagiline group (3.2 points) than in the placebo controls (0.2 points). This difference of 3 points was slightly lower than 4.2 points observed after 26 weeks monotherapy with 1 mg/day rasagiline in Caucasian patients in the TEMPO study [ 10 ] but comparable to that reported by the ADAGIO study of Caucasian people (3.01 point difference) but treated with 1 mg/d rasagiline for a longer study period of 36 weeks [ 11 ]. Notably, the TEMPO study enrolled patients whose disease severity was Hoehn and Yahr stage 3 or lower, whereas the ADAGIO study included subjects with stage 2.5 or lower, same as in the current study.…”