Table 3.
Trial | Duration | Treatment | Patient baseline characteristics | |||
---|---|---|---|---|---|---|
Age (y) | Disease duration (y) | Levodopa dose (mg/day) | ||||
Entacapone trials* (n= 1560) | ||||||
Brooks and Sagar 2003 | 24 wk | Placebo | n= 97 | 65.3 | 9.4 | 697.0 |
200 mg | n= 203 | |||||
Fénelon et al. 2003 | 52 wk | Placebo | n= 63 | 64.2 | (Not available) | (Not available) |
200 mg | n= 99 | |||||
Im et al. 2002 | 8 wk | Placebo | n= 99 | (Not available) | (Not available) | (Not available) |
(entacapone dose not given) | n= 98 | |||||
Myllyla et al. 2001 | 52 wk | Placebo | n= 108 | 62.2 | 6.1 | 634.0 |
200 mg | n= 218 | |||||
Parkinson Study Group. 1997 | 24 wk | Placebo | n= 102 | 63.3 | 11.1 | 772.0 |
200 mg | n= 103 | |||||
Poewe et al. 2002 | 24 wk | Placebo | n= 104 (88 fluct.) | 61.0 | 8.9 | 571.0 |
200 mg | n= 197 (172 fluct.) | |||||
Rinne et al. 1998 | 24 wk | Placebo | n= 86 | 62.7 | 10.8 | 703.0 |
200 mg | n= 85 | |||||
Ruottinen and Rinne 1996 ‡ | 8 wk | Placebo | n= 22 | 61.3 | 14.0 | 905.0 |
200 mg | n= 23 | |||||
Tolcapone trials (n = 1006) | ||||||
Adler et al. 1998 | 6 wk | Placebo | n= 72 | 62.0 | 10.5 | (Not available) |
100 mg t.i.d. | n= 69 | |||||
200 mg t.i.d. | n= 74 | |||||
Baas et al. 1997 | 3 mo | Placebo | n= 58 | 63.0 | 9.8 | 668.0 |
100 mg t.i.d. | n= 60 | |||||
200 mg t.i.d. | n= 59 | |||||
Dupont et al. 1997 ‡† | 6 wk | Placebo | n= 33 | 66.0 | (Not available) | 662.0 |
200 mg t.i.d. | n= 32 | |||||
Kurth et al. 1997 † | 6 wk | Placebo | n= 42 | 64.5 | 9.2 | (Not available) |
200 mg t.i.d. | n= 40 | |||||
Myllyla et al. 1997 † | 6 wk | Placebo | n= 42 | 63.0 | 11.0 | 734.0 |
200 mg t.i.d. | n= 38 | |||||
Rajput et al. 1997 | 24 wk | Placebo | n= 66 | 64.0 | 10.9 | 867.4 |
100 mg t.i.d. | n= 69 | |||||
200 mg t.i.d. | n= 67 |
*For all entacapone trials, dosing with either placebo or entacapone occurred with each dose of levodopa, up to 10 times daily.
†Trial also included groups that received nonapproved doses of tolcapone (50 or 400 mg t.i.d.).
‡Crossover study; all others shown used parallel‐group designs.