BetaEntity Annotation Prototype
← Back to drugs

Annotated abstract

3441 Randomized double-blind study of selegiline versus placebo therapy in 32 fluctuating parkinson’s disease patients on levodopa/dopamine agonist therapy

bmjno · 2025-10-23 · canonical JSON source

24 visible annotations · policy: published · automated confidence ≥ 75.00%

Document resource

Background/objectives Selegiline, a selective MAO-B inhibitor increases synaptic dopamine and impulse mediated neuronal release of dopamine. The objective was to assess whether Selegiline increased and prolonged the effect of levodopa in Parkinson’s Disease.Methods Sixteen patients were randomised to Selegiline for 16 weeks with a 5 week washout and then transferred to placebo for 16 weeks. Sixteen patients were randomised to placebo for 16 weeks with a 5 week washout then transferred to Selegiline for 16 weeks. Twenty seven patients were kept on Sinemet (mean 605 mg/day), five on Madopar (mean 540mg/day) and thirty one on bromocriptine (mean 12.4 mg/day) without any alteration in levodopa/bromocriptine dose throughout the study. Parkinsonian symptoms/signs were scored with the Unified Parkinson’s Disease Rating Scale (UPDRS) at zero hour, 8:00am, ten hours after the preceding night-time levodopa/bromocriptine dose and immediately before ingestion of the test drug Selegiline 5mg or placebo and morning dose of levodopa/bromocriptine. UPDRS scores were then measured every hour for 4 hours. This 4 hour UPDRS scoring sequence was repeated in each patient at the beginning and end of active and placebo phases.Results Selegiline significantly improved mean baseline (zero hour) UPDRS score (ANOVA) and prolonged the mean response to levodopa by one and a half hours (drug by time interaction, p=0.014) . Selegiline didn’t significantly improve peak response to levodopa but increased dyskinesia one hour after levodopa intakeConclusion Selegiline (12.5 mg/day) in the majority of patients prolonged response to levodopa with improved early morning scores.