Clinical Trials Of Rasagiline Tempo

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Subjects with early PD (n = 404) were evaluated in a phase III study called TEMPO (Rasagiline Mesylate [TVP-1012] in Early Monotherapy for Parkinson's Disease Outpatients) (94). Subjects were randomized to receive rasagiline 1 mg/day (n = 134), rasagiline 2 mg/day (n = 132), or placebo (n = 138), with the change in total UPDRS scores between baseline and 26 weeks as the primary outcome measure. Significant improvements in total UPDRS scores were observed for both rasagiline 1 mg/day and rasagiline 2 mg/day (-4.2 and -3.6, respectively) compared with placebo (P < 0.001 for each comparison) (94). Two-thirds of both rasagiline groups compared to approximately one-half of the placebo group were responders (defined as less than 3 points worsening in total UPDRS scores from baseline to week 26; P < 0.01 for each rasagiline group compared with placebo). Secondary endpoints including UPDRS motor and ADL subscales, and the Parkinson's disease quality of life scale (PDQUALIF), an assessment of quality of life, significantly favored both dosages of rasagiline compared with placebo. The need for levodopa did not differ among the groups (16.7% for placebo, 11.2% for rasagiline 1 mg, and 16.7% for rasagiline 2 mg). Rasagiline was very well tolerated.

The TEMPO study included an open treatment phase, in which all subjects who completed 26 weeks of the double-blind, placebo-controlled phase were placed on rasagiline. Those treated with rasagiline 1 mg/day or 2 mg/day from the start remained on that dosage for the full 12 months, whereas subjects initially treated with placebo for the first six months were then treated with rasagiline 2 mg/day (delayed start) (95). There were 380 subjects enrolled, and the intention-to-treat cohort consisted of 371 subjects. The primary outcome measure was the change in total UPDRS from baseline to 12 months. Subjects treated with rasagiline 2 mg/day for one year were 2.29 points better on the total UPDRS than subjects initially treated with placebo for six months followed by rasagiline 2mg/day for six months

(P = 0.01). Subjects who received rasagiline 1 mg/day for one year also experienced less worsening of total UPDRS scores than those treated with placebo for six months followed by rasagiline 2 mg/day for 6 months (1.82 points better total UPDRS in the 1 mg/d group; P = 0.05). The better outcome of patients who took rasagiline for the full year suggests that rasagiline may slow progression of disability in PD. Further studies are currently underway to confirm this effect.

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