Table 2 Major trials for selegiline and rasagiline
From: Monoamine oxidase-B (MAO-B) inhibitors: implications for disease-modification in Parkinson’s disease
Selegiline | Rasagiline | ||
|---|---|---|---|
DATATOP 1993 [13] | TEMPO 2004 [31] | ||
Study design | RCT selegiline vs. placebo | Study design | Randomized, delayed start trial rasagiline for 1 year vs. 6 months placebo then 6 months rasagiline |
Participants | 800 patients | Participants | 404 patients |
Follow up period | 2 years | Follow up period | 1 year |
End point | Functional disability requiring levodopa | End point | Change in UPDRS score |
Major finding | Need for levodopa delayed by 9 months in the selegiline group | Major finding | Slower disease deterioration in the early start rasagiline group |
Conclusion | Symptomatic benefit | Conclusion | Symptomatic benefit |
Possible disease-modifying effect | |||
SELEDO 1999 [19] | PRESTO 2005 [28] | ||
Study design | RCT selegiline vs. placebo, as adjunct to levodopa | Study design | RCT rasagiline vs. placebo, as adjunct to levodopa |
Participants | 116 patients | Participants | 472 patients with daily off time |
Follow up period | 5 years | Follow up period | 26 weeks |
End point | Increase in >50% of initial levodopa dose | End point | Total daily off time |
Major finding | Primary end point delayed in the selegiline group | Major finding | Less off time in the rasagiline group |
Conclusion | Symptomatic benefit as adjunct to levodopa | Conclusion | Symptomatic benefit as adjunct to levodopa |
Larsen 1999 [17] | LARGO 2005 [29] | ||
Study design | RCT selegiline vs. placebo, as adjunct to madopar. 1 month wash out of selegiline at the end of study period | Study design | RCT rasagiline vs. entacapone vs. placebo, as adjunct to levodopa |
Participants | 163 patients | Participants | 687 patients with daily off time |
Follow up period | 5 years | Follow up period | 18 weeks |
End point | Levodopa requirement and deterioration of UPDRS score | End point | Total daily off time |
Major finding | Lower levodopa requirement and UPDRS score in the selegiline group | Major finding | Less off time in the rasagiline group |
Conclusion | Symptomatic benefit as adjunct to madopar | Conclusion | Symptomatic benefit as adjunct to levodopa |
Possible disease-modifying effect | |||
Palhagen 2006 [16] | ADAGIO 2009 [35] | ||
Study design | RCT selegiline vs. placebo, as adjunct to levodopa | Study design | Randomized, delayed start trial rasagiline for 72 weeks vs. 36 weeks placebo then 36 weeks rasagiline |
Participants | 140 patients | Participants | 1176 patients |
Follow up period | 7 years | Follow up period | 72 weeks |
End point | Deterioration of UPDRS score | End point | Three hierarchical end points to indicate significant disease-modification |
Major finding | Slower disease deterioration in the selegiline group | Major finding | Rasagiline 1 mg/day achieved all three hierarchical end points, but not in 2 mg/day dose |
Conclusion | Symptomatic benefit as adjunct to levodopa | Conclusion | Possible disease-modifying effect |