Rotigotine Versus Placebo, A Study To Evaluate The Efficacy In Advanced Stage Idiopathic Parkinson's Disease Patients

PHASE3CompletedINTERVENTIONAL
Enrollment

346

Participants

Timeline

Start Date

July 31, 2012

Primary Completion Date

October 31, 2014

Study Completion Date

October 31, 2014

Conditions
Idiopathic Parkinson's Disease
Interventions
DRUG

Rotigotine

"Transdermal Patch~Content:~4 mg /24 h (20 cm\^2), 6 mg /24 h (30 cm\^2), 8 mg /24 h (40 cm\^2)~For advanced-stage Parkinson's Disease, subjects received Rotigotine patches in escalating weekly dose (starting with daily doses 4 mg/24 h to 16 mg/24 h) for a maximum 7-week Titration Period, then 12 week maintenance period"

DRUG

Placebo Patch

"Transdermal Patch~Size:~20 cm\^2, 30 cm\^2, 40 cm\^2~Subjects randomized to placebo received matching placebo patches"

DRUG

L-dopa

Subject must be on a stable dose of L-dopa (either short-acting or sustained release \[in combination with benserazide or carbidopa\]) of at least 200 mg/day, administered in at least 2 intakes, for at least 28 days prior to Baseline.

Trial Locations (24)

Unknown

Sp1037 001, Beijing

Sp1037 002, Beijing

Sp1037 019, Beijing

Sp1037 025, Beijing

Sp1037 017, Changchun

Sp1037 007, Chengdu

Sp1037 027, Chengdu

Sp1037 021, Fuzhou

Sp1037 010, Guangzhou

Sp1037 011, Guangzhou

Sp1037 014, Guangzhou

Sp1037 015, Guangzhou

Sp1037 005, Hangzhou

Sp1037 013, Hangzhou

Sp1037 018, Hangzhou

Sp1037 023, Jinan

Sp1037 003, Shanghai

Sp1037 004, Shanghai

Sp1037 009, Shanghai

Sp1037 008, Suzhou

Sp1037 016, Tianjin

Sp1037 006, Wuhan

Sp1037 022, Wuhan

Sp1037 024, Wuhan

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

UCB Trading (Shanghai) Co. Ltd.

UNKNOWN

lead

UCB Pharma

INDUSTRY

NCT01646255 - Rotigotine Versus Placebo, A Study To Evaluate The Efficacy In Advanced Stage Idiopathic Parkinson's Disease Patients | Biotech Hunter | Biotech Hunter