Other Trials in Early Parkinsons Disease

The Parkinson's-Reversing Breakthrough

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Palhagen et al. (72) reported a study of selegiline in 157 de novo PD subjects. Selegiline 10 mg/day delayed the need for levodopa by four months compared with placebo (P=0.028). There was a "wash-in" effect at six weeks and three months, with total and motor UPDRS scores significantly better in the selegiline group. At six months, the rate of disease progression was significantly slower for both total UPDRS (-1.9 vs. 3.5; P < 0.001) and motor UPDRS (-1.5 vs. 2.5; P < 0.001) (negative numbers refer to improvement and positive numbers refer to worsening). Between baseline and the end of an eight week washout period, there was significantly slower progression of total UPDRS scores in the selegiline group (11.3) compared with the placebo group (14.2), when length of time to reach the endpoint was used as a covariate (P = 0.033) (72).

The French Selegiline Multicenter Trial (77) randomized 93 de novo PD subjects to selegiline 10 mg/day or placebo. Significant improvements in total and motor UPDRS scores were noted at one and three months. In a small double-blind randomized trial (71) of 54 early PD patients, selegiline 10 mg/day delayed the need for levodopa by eight months (log rank test, P < 0.002), and delayed disease progression as assessed by five different scales (including UPDRS motor score) by 40% to 83% per year compared to placebo. The Finnish Study of selegiline monotherapy found that selegiline delayed the need for levodopa by nearly six months (P = 0.03), and disability measured by three different scales was reduced at 12 months with selegiline compared with placebo. At the end of two years on levodopa, the increase in daily levodopa dosage was significantly lower in the selegiline group compared with placebo (86 mg vs. 250 mg; P <0.001) (73). The selegiline group could also be managed with fewer mean daily doses of levodopa compared with placebo (3.5 vs. 4.5) (73).

In the SINDEPAR (Sinemet-Deprenyl-Parlodel) study (78), 101 untreated PD patients were randomized to selegiline or placebo, in addition to being randomized to symptomatic treatment with bromocriptine or levodopa [i.e., four treatment arms - (selegiline or placebo) + (levodopa or bromocriptine)]. After a two-month washout of selegiline and a one-week washout of bromocriptine and levodopa, endpoint evaluation at 14 months revealed significantly less worsening of total UPDRS scores with selegiline compared to placebo regardless of the symptomatic treatment used (0.4 vs. 5.8, P < 0.001) (78).

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