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Trial of subtherapeutic pergolide in de novo Parkinson's disease
Author(s) -
Grosset Katherine,
Grosset Donald,
Lees Andrew
Publication year - 2005
Publication title -
movement disorders
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.352
H-Index - 198
eISSN - 1531-8257
pISSN - 0885-3185
DOI - 10.1002/mds.20361
Subject(s) - pergolide , placebo , medicine , levodopa , parkinson's disease , anesthesia , adverse effect , confidence interval , clinical endpoint , randomized controlled trial , disease , alternative medicine , pathology , bromocriptine , hormone , prolactin
The effect of pergolide 25 μg twice daily on levodopa initiation was assessed in a randomized, placebo‐controlled, parallel group, double‐blind multicenter trial in 106 untreated early Parkinson's disease patients. The primary endpoint of mean time until levodopa was 520 days (95% confidence interval [CI], 422–618 days) for pergolide versus 434 days (95% CI, 358–609 days) for placebo. However, this increase of 86 days for pergolide was not statistically significant. The wash‐in effect of pergolide was significant at 6 weeks (change in mean Unified Parkinson's Disease Rating Scale [UPDRS] 2 and 3 was −0.1 [95% CI, −1.4 to 1.3] for pergolide vs. 2.2 [95% CI, 1.1–3.3] for placebo). At termination, the change from baseline in mean UPDRS 2 and 3 score was 11.4 (95% CI, 8.8–14) for pergolide and 14.6 (95% CI, 12–17.2) for placebo ( P = 0.08). There was no significant change in UPDRS 2 and 3 for the 83 patients achieving the planned 4‐week washout at termination (pergolide 1.2 [95% CI, −0.8 to 3.2] vs. placebo 0.0 [95% CI, −1.6 to 1.6]. Adverse events were infrequent and occurred equally for pergolide and placebo. The study shows no evidence of a neuroprotective effect but indicates a mild symptomatic benefit from pergolide at a dose normally considered subtherapeutic. © 2004 Movement Disorder Society