"Efficacy and Tolerability of Nebicapone in Parkinson's Disease Patients With Wearingoff Phenomenon"

PHASE2CompletedINTERVENTIONAL
Enrollment

254

Participants

Timeline

Start Date

September 26, 2006

Primary Completion Date

September 21, 2007

Study Completion Date

September 21, 2007

Conditions
Parkinson Disease
Interventions
DRUG

Comtan®

200 mg entacapone were to be taken concomitantly with each levodopa/DDCI dose.

DRUG

Nebicapone

50 mg, 100 mg and 150 mg doses of nebicapone were to be taken concomitantly with each levodopa/DDCI dose.

DRUG

Levodopa/DDCI

"Prior to the study, all patients were to have been receiving levodopa/DDCI therapy for at least 1 year with clear clinical improvement. At entry to the study, patients were to be receiving levodopa/DDCI therapy of at least 4 but not more than 8 (inclusive) standard daily doses.~All patients were to continue receiving levodopa/DDCI during the study. Levodopa and DDCI were prescribed by the investigators and purchased locally by patients."

DRUG

Placebo

Administered orally as encapsulated tablets, which were identical in appearance to the study drugs

All Listed Sponsors
lead

Bial - Portela C S.A.

INDUSTRY

NCT03103399 - "Efficacy and Tolerability of Nebicapone in Parkinson's Disease Patients With Wearingoff Phenomenon" | Biotech Hunter | Biotech Hunter