Rotigotine Versus Placebo to Evaluate the Efficacy on Depressive Symptoms in Idiopathic Parkinson's Disease Patients

PHASE4CompletedINTERVENTIONAL
Enrollment

380

Participants

Timeline

Start Date

April 30, 2012

Primary Completion Date

October 31, 2014

Study Completion Date

October 31, 2014

Conditions
Idiopathic Parkinson's Disease
Interventions
DRUG

Rotigotine

"Transdermal Patch~Content:~2 mg /24 h (10 cm\^2), 4 mg /24 h (20 cm\^2), 6 mg /24 h (30 cm\^2), 8 mg /24 h (40 cm\^2)~* For early-stage Parkinson's disease, Subjects received Rotigotine patches in escalating weekly dose (starting with daily doses 2 mg/24 h to 8 mg/24 h) for a maximum 4-week Titration Period, then 8 week Maintenance period~* 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 8 week Maintenance period"

DRUG

Placebo

"Transdermal Patch~Size:~10 cm\^2, 20 cm\^2, 30 cm\^2, 40 cm\^2~Subjects randomized to placebo received matching placebo patches"

Trial Locations (29)

Unknown

03, Ansan

19, Anyang

08, Busan

26, Busan

04, Daegu

05, Daegu

16, Daejeon

28, Goyang

24, Gwangju

29, Gwangju

11, Gyeonggi-do

15, Jinju

23, Jungbuk

01, Seoul

02, Seoul

06, Seoul

07, Seoul

09, Seoul

10, Seoul

12, Seoul

13, Seoul

14, Seoul

17, Seoul

18, Seoul

20, Seoul

21, Seoul

22, Seoul

27, Seoul

25, Yangsan

All Listed Sponsors
lead

UCB Korea Co., Ltd.

INDUSTRY

NCT01523301 - Rotigotine Versus Placebo to Evaluate the Efficacy on Depressive Symptoms in Idiopathic Parkinson's Disease Patients | Biotech Hunter | Biotech Hunter