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

Double Blind, Placebo-controlled, Parallel, Multicenter, Randomized Interventional Phase IV Study to Evaluate the Efficacy of Rotigotine on Depressive Symptoms in Idiopathic Parkinson's Disease Patients

Sponsors

Lead Sponsor: UCB Korea Co., Ltd.

Source UCB Pharma
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.

Overall Status Completed
Start Date April 2012
Completion Date October 2014
Primary Completion Date October 2014
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Change From Baseline to the End of Maintenance Period in the Score of the Hamilton Depression Scale (HAM-D) From Baseline (Week 0) to end of Maintenance Period (up to Week 15)
Secondary Outcome
Measure Time Frame
Change From Baseline to the End of Maintenance Period in the Score of Beck Depression Inventory (BDI-II) From Baseline (Week 0) to end of Maintenance Period (up to Week 15)
Change From Baseline to the End of Maintenance Period in the Score of Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living-ADL Subscale) From Baseline (Week 0) to end of Maintenance Period (up to Week 15)
Change From Baseline to the End of Maintenance Period in the Score of Unified Parkinson's Disease Rating Scale (UPDRS) Part III (Motor Subscale) From Baseline (Week 0) to end of Maintenance Period (up to Week 15)
Change From Baseline to the End of Maintenance Period in the Combined Score of Unified Parkinson's Disease Rating Scale (UPDRS) Part II (ADL) Plus Part III (Motor Subscale) From Baseline (Week 0) to end of Maintenance Period (up to Week 15)
Change From Baseline to the End of Maintenance Period in the Score of Apathy Scale (AS) From Baseline (Week 0) to end of Maintenance Period (up to Week 15)
Change From Baseline to the End of Maintenance Period in the Score of Snaith-Hamilton Pleasure Scale (SHAPS) From Baseline (Week 0) to end of Maintenance Period (up to Week 15)
Enrollment 380
Condition
Intervention

Intervention Type: Drug

Intervention Name: Rotigotine

Description: 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

Arm Group Label: Rotigotine

Intervention Type: Drug

Intervention Name: Placebo

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

Arm Group Label: Placebo

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

Gender: All

Minimum Age: 20 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
UCB Clinical Trial Call Center Study Director +1 877 822 9493 (UCB)
Location
Facility:
03 | Ansan, Korea, Republic of
19 | Anyang, Korea, Republic of
08 | Busan, Korea, Republic of
26 | Busan, Korea, Republic of
23 | Chungbuk, Korea, Republic of
04 | Daegu, Korea, Republic of
05 | Daegu, Korea, Republic of
16 | Daejon, Korea, Republic of
28 | Goyang, Korea, Republic of
24 | Gwangju, Korea, Republic of
29 | Gwangju, Korea, Republic of
11 | Gyeonggi-Do, Korea, Republic of
15 | Jinju, Korea, Republic of
01 | Seoul, Korea, Republic of
02 | Seoul, Korea, Republic of
06 | Seoul, Korea, Republic of
07 | Seoul, Korea, Republic of
09 | Seoul, Korea, Republic of
10 | Seoul, Korea, Republic of
12 | Seoul, Korea, Republic of
13 | Seoul, Korea, Republic of
14 | Seoul, Korea, Republic of
17 | Seoul, Korea, Republic of
18 | Seoul, Korea, Republic of
20 | Seoul, Korea, Republic of
21 | Seoul, Korea, Republic of
22 | Seoul, Korea, Republic of
27 | Seoul, Korea, Republic of
25 | Yangsan, Korea, Republic of
Location Countries

Korea, Republic of

Verification Date

November 2015

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Rotigotine

Type: Experimental

Description: Rotigotine, daily doses, treatment group

Label: Placebo

Type: Placebo Comparator

Description: Placebo, daily doses, placebo group

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov