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

Purpose

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

Condition	Intervention	Phase
Idiopathic Parkinson's Disease	Drug: Rotigotine Drug: Placebo Patch	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Double Blind, Placebo-controlled, Parallel, Multicenter, Randomized Interventional Phase IV Study to Evaluate the Efficacy of Rotigotine in Depressive Symptoms in Idiopathic Parkinson's Disease Patients

Resource links provided by NLM:

Genetics Home Reference related topics: Parkinson disease Perry syndrome

MedlinePlus related topics: Depression Parkinson's Disease

Drug Information available for: Rotigotine

U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:

Change from the Baseline to the end of Maintenance Period in the score of the Hamilton Depression Scale (HAM-D) [ Time Frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 15) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from Baseline to the end of Maintenance Period in the score of Beck Depression Inventory (BDI-II) [ Time Frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 15) ] [ Designated as safety issue: No ]
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) [ Time Frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 15) ] [ Designated as safety issue: No ]
Change from Baseline to the end of Maintenance Period in the score of Unified Parkinson's Disease Rating Scale (UPDRS) part III (motor subscale) [ Time Frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 15) ] [ Designated as safety issue: No ]
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) [ Time Frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 15) ] [ Designated as safety issue: No ]
Change from Baseline to the end of Maintenance Period in the score of Apathy Scale (AS) [ Time Frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 15) ] [ Designated as safety issue: No ]
Change from Baseline to the end of Maintenance Period in the score of Snaith-Hamilton Pleasure Scale (SHAPS) [ Time Frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 15) ] [ Designated as safety issue: No ]

Estimated Enrollment:	266
Study Start Date:	April 2012
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Rotigotine Rotigotine, daily doses, treatment group	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, receive 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, receive 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 Comparator: Placebo Placebo, daily doses, placebo group	Drug: Placebo Patch Transdermal Patch Size: 10 cm^2, 20 cm^2, 30 cm^2, 40 cm^2 Subjects randomized to placebo will receive matching placebo patches

Arms

Assigned Interventions

Experimental: Rotigotine

Rotigotine, daily doses, treatment group

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, receive 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, receive 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 Comparator: Placebo

Placebo, daily doses, placebo group

Drug: Placebo Patch

Transdermal Patch

Size:

10 cm^2, 20 cm^2, 30 cm^2, 40 cm^2 Subjects randomized to placebo will receive matching placebo patches

Detailed Description:

The study includes 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 will be 19 weeks and 23 weeks, respectively.

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 Hamilton Depression Scale (HAM- D) 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01523301

Contacts

Contact: UCB Clinical Trial Call Center

+1 877 822 9493

Locations

Korea, Republic of
03	Recruiting
Ansan, Korea, Republic of
19	Recruiting
Anyang, Korea, Republic of
08	Recruiting
Busan, Korea, Republic of
26	Recruiting
Busan, Korea, Republic of
23	Recruiting
Chungbuk, Korea, Republic of
04	Recruiting
Daegu, Korea, Republic of
05	Recruiting
Daegu, Korea, Republic of
16	Recruiting
Daejon, Korea, Republic of
28	Recruiting
Goyang, Korea, Republic of
29	Recruiting
Gwangju, Korea, Republic of
24	Recruiting
Gwangju, Korea, Republic of
11	Recruiting
Gyeonggi-Do, Korea, Republic of
15	Recruiting
Jinju, Korea, Republic of
22	Recruiting
Seoul, Korea, Republic of
01	Recruiting
Seoul, Korea, Republic of
02	Recruiting
Seoul, Korea, Republic of
07	Recruiting
Seoul, Korea, Republic of
09	Recruiting
Seoul, Korea, Republic of
10	Recruiting
Seoul, Korea, Republic of
12	Recruiting
Seoul, Korea, Republic of
13	Recruiting
Seoul, Korea, Republic of
14	Recruiting
Seoul, Korea, Republic of
17	Recruiting
Seoul, Korea, Republic of
18	Recruiting
Seoul, Korea, Republic of
20	Recruiting
Seoul, Korea, Republic of
21	Recruiting
Seoul, Korea, Republic of
27	Recruiting
Seoul, Korea, Republic of
06	Recruiting
Seoul, Korea, Republic of
25	Recruiting
Yangsan, Korea, Republic of

Sponsors and Collaborators

UCB, Inc.

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

More Information

No publications provided

Responsible Party:	UCB, Inc.
ClinicalTrials.gov Identifier:	NCT01523301 History of Changes
Other Study ID Numbers:	SP1041
Study First Received:	January 27, 2012
Last Updated:	April 5, 2013
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by UCB, Inc.:

Rotigotine
Neupro
Depressive Symptom
Idiopathic Parkinson's disease

Additional relevant MeSH terms:

Parkinson Disease
Depression
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

Behavioral Symptoms
N 0437
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013