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

NCT ID: NCT01523301

Last Updated: 2015-12-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 380 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2014-10-31

Brief Summary

The purpose of this study was to show superiority of Rotigotine over placebo on improvement of depressive symptoms in subjects with idiopathic Parkinson's disease.

Detailed Description

The study included a maximum 2-week Screening Period, a maximum 4-week Titration Period for early-stage Parkinson's disease or maximum 7-week Titration Period for advanced-stage Parkinson's disease, 8-week Maintenance Period, a maximum 6-day De-escalation Period for early-stage Parkinson's disease or maximum 12-day De-escalation Period for advanced-stage Parkinson's disease and 30-day Safety Follow-Up Period.

The maximum study durations for an individual subject with early-stage Parkinson's disease and with advanced-stage Parkinson's disease were 19 weeks and 23 weeks, respectively.

Conditions

Idiopathic Parkinson's Disease

Keywords

Rotigotine; Neupro; Depressive Symptom; Idiopathic Parkinson's disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Rotigotine

Rotigotine, daily doses, treatment group

Group Type: EXPERIMENTAL

Rotigotine

Intervention Type: DRUG

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

Placebo

Placebo, daily doses, placebo group

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Transdermal Patch

Size:

10 cm^2, 20 cm^2, 30 cm^2, 40 cm^2

Subjects randomized to placebo received matching placebo patches

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male or female subjects ≥ 20 years old
• Subjects diagnosed with idiopathic Parkinson's disease (according to the United Kingdom Parkinson's Disease Society Brain Bank Diagnostic Criteria for Parkinson's disease) at modified Hoehn and Yahr Scale stages I-III; do not have motor fluctuations, dyskinesia, and have stable motor symptom at least 4 weeks prior to the Screening Visit as judged by the local investigator
• Subject has a Beck Depression Inventory II (BDI-II) score ≥ 16 as evidenced by depression rating scale study in Parkinson's disease (Schrag A et al, 2007)
• Subject has a Mini-Mental State Examination (MMSE) score ≥ 24
• If subject is taking Levodopa (L-DOPA) and derivatives, Monoamine Oxidase (MAO) B-inhibitors, anticholinergics agents, Catechol-O-Methyl Transferase (COMT) inhibitor or N-Methyl-D-Aspartate (NMDA) antagonist, he/she must have been on stable dose for at least 28 days prior to the Screening Visit
• If subject is taking an antidepressant drug such as selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), bupropion, tricyclic antidepressants (TCAs), he/she must have been on a stable dose for at least 28 days prior to the Screening Visit and be maintained on that dose for the duration of the trial

Exclusion Criteria

• Subject has any medical or psychiatric condition (ie, bipolar disorder, dementia, hallucinations or psychosis) that, in the opinion of the investigator, could jeopardize or would compromise the subject's ability to participate in this study
• Subject has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response ('Yes') to either Question 4 or Question 5 of the C-SSRS at Screening (Visit 1)
• Current psychotherapy or behavior therapy while participating in this study
• Subject has received electroconvulsive therapy within 12 weeks of the Screening Visit
• Subject who has received dopamine agonists within 28 days of the Screening Visit
• Subject who has received neuroleptics, methylphenidate, reserpine, alpha-methyldopa, metoclopramide, levosulpiride or amphetamine derivatives within 28 days of the Screening Visit

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UCB Korea Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

+1 877 822 9493 (UCB)

Locations

03

Ansan, , South Korea

19

Anyang, , South Korea

08

Busan, , South Korea

26

Busan, , South Korea

04

Daegu, , South Korea

05

Daegu, , South Korea

16

Daejeon, , South Korea

28

Goyang, , South Korea

24

Gwangju, , South Korea

29

Gwangju, , South Korea

11

Gyeonggi-do, , South Korea

15

Jinju, , South Korea

23

Jungbuk, , South Korea

01

Seoul, , South Korea

02

Seoul, , South Korea

06

Seoul, , South Korea

07

Seoul, , South Korea

09

Seoul, , South Korea

10

Seoul, , South Korea

12

Seoul, , South Korea

13

Seoul, , South Korea

14

Seoul, , South Korea

17

Seoul, , South Korea

18

Seoul, , South Korea

20

Seoul, , South Korea

21

Seoul, , South Korea

22

Seoul, , South Korea

27

Seoul, , South Korea

25

Yangsan, , South Korea

Countries

South Korea

References

Chung SJ, Asgharnejad M, Bauer L, Ramirez F, Jeon B. Evaluation of rotigotine transdermal patch for the treatment of depressive symptoms in patients with Parkinson's disease. Expert Opin Pharmacother. 2016 Aug;17(11):1453-61. doi: 10.1080/14656566.2016.1202917. Epub 2016 Jul 7.

Reference Type: DERIVED

PMID: 27322571 (View on PubMed)

Other Identifiers

SP1041

Identifier Type: -

Identifier Source: org_study_id