A Study to Assess the Effect of Safinamide on Levodopa Pharmacokinetics
|ClinicalTrials.gov Identifier: NCT01026428|
Recruitment Status : Completed
First Posted : December 4, 2009
Last Update Posted : March 29, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Idiopathic Parkinson's Disease||Drug: Safinamide + Levodopa Other: Placebo + Levodopa||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||July 2010|
|Experimental: Safinamide + Levodopa||
Drug: Safinamide + Levodopa
Treatment A: 100mg safinamide once daily administration for 6 days + immediate release levodopa formulation (100 mg levodopa + 25 mg carbidopa = Nacom®).
|Placebo Comparator: Placebo + Levodopa||
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®).
- AUC and Cmax of Levodopa [ Time Frame: Main pharmacocinetics measurements will be taken at Day 1 and 6 of each period. ]
- tmax, CL, t1/2 of Levodopa [ Time Frame: Main pharmacocinetics measurements will be taken at Day 1 and 6 of each period. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01026428
|Study Director:||Sonja Krösser, PhD||Merck KGaA|