Conditions: Parkinson's Disease
Keywords: Parkinson's Disease BIA 9-1067
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 10
Healthy volunteers: no

Brief summary:
The purpose of this study is to investigate the effect of BIA 9-1067 on the levodopa pharmacokinetics when administered in combination with immediate release levodopa/carbidopa or levodopa/benserazide in Parkinson's Disease (PD) patients.

Detailed description:
This was a three-centre, double-blind, randomised, placebo-controlled, crossover study with four consecutive single-dose treatment periods in PD patients treated with immediate release 100 mg/25 mg levodopa/carbidopa or 100 mg/25 mg levodopa/benserazide

Arms:
arm 1: Treatment Sequence A Period 1 - 25 mg BIA 9-1067 Period 2 - 50 mg BIA 9-1067 Period 3 - 100 mg BIA 9-1067 Period 4 - Placebo

Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half arm 2: Treatment Sequence B Period 1 - Placebo Period 2 - 25 mg BIA 9-1067 Period 3 - 50 mg BIA 9-1067 Period 4 - 100 mg BIA 9-1067

Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half arm 3: Treatment Sequence C Period 1 - 100 mg BIA 9-1067 Period 2 - Placebo Period 3 - 25 mg BIA 9-1067 Period 4 - 50 mg BIA 9-1067

Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half arm 4: Treatment Sequence D Period 1 - 50 mg BIA 9-1067 Period 2 - 100 mg BIA 9-1067 Period 3 - Placebo Period 4 - 25 mg BIA 9-1067

Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half

Interventions: intervention 1: BIA 9-1067 intervention 2: BIA 9-1067 intervention 3: BIA 9-1067 intervention 4: Placebo intervention 5: Levodopa/Carbidopa intervention 6: Levodopa/Benzerazide
Intervention descriptions: intervention 1: BIA 9-1067 - 25 mg single-dose intervention 2: BIA 9-1067 - 50 mg single-dose intervention 3: BIA 9-1067 - 100 mg single-dose intervention 4: single-dose intervention 5: Levodopa 100 mg Carbidopa 25 mg intervention 6: Levodopa 100 mg Benzerazide 25 mg

Protocol document: