NCT01026428

A Study to Assess the Effect of Safinamide on Levodopa Pharmacokinetics

A Randomised, Double-blind, Placebo-controlled, Two-period, Two-sequence-crossover Interaction Study to Assess the Effect of Safinamide on Levodopa Pharmacokinetics in Subjects With Parkinson's Disease

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Newron Pharmaceuticals SPA · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to investigate the effect of safinamide on levodopa blood levels, both after single and multiple dosing of safinamide . A further objective of the study is to assess the safety and tolerability of safinamide when given together with levodopa in the applied regimen. For that purpose, all study participants will undergo intensive blood sampling for investigation of levodopa levels and various tolerability examinations, such as the measurement of vital signs (blood pressure, pulse, body temperature), recording of ECGs and questioning to find out how the study participants are feeling. Furthermore, blood samples will be drawn and urine tests will be performed repeatedly for safety purpose during the course of the study. The results of this clinical trial may be used for the drug registration of safinamide in the future.

Detailed description

Treatments are given in a crossover design.

Conditions

• Idiopathic Parkinson's Disease

Interventions

Type	Name	Description
DRUG	Safinamide + Levodopa	Treatment A: 100mg safinamide once daily administration for 6 days + immediate release levodopa formulation (100 mg levodopa + 25 mg carbidopa = Nacom®).
OTHER	Placebo + Levodopa	Treatment B: Placebo matching 100mg safinamide once daily administration for 6 days + immediate release levodopa formulation (100 mg levodopa + 25 mg carbidopa = Nacom®).

Timeline

• Start date: 2009-09-01
• Primary completion: 2010-07-01
• First posted: 2009-12-04
• Last updated: 2013-03-29

Locations

2 sites across 1 country: Italy