Clinical trial NCT01744496: Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease-Associated Pain
Official title: A Multicenter, Multinational, Double-Blind, Placebo-Controlled, 2-Arm Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease-Associated Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Advanced Idiopathic Parkinson's Disease
Keywords: Parkinson's Disease
Rotigotine
Chronic Pain
Nonmotor symptoms
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2012-12-06
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is being conducted to compare the impact of Rotigotine and Placebo on Chronic Pain associated with Parkinson's Disease among patients with advanced stages of the disease.


Eligibility criteria: Inclusion Criteria:

* Patient has advanced idiopathic Parkinson's Disease associated chronic pain assessed by a Likert Pain Scale
* Patient is taking Levodopa with a stable daily dose of at least 200 mg for at least 21 days prior to start
* Hoehn and Yahr stage score of II to IV
* Mini-Mental State Examination (MMSE) score ≥ 25
* If an antidepressant drug is taken, the dose must be stable for at least 21 days

Exclusion Criteria:

* Therapy with a Dopamine Agonist within 21 days prior to start
* Discontinuation from previous Dopamine Agonist Therapy due to lack of efficacy
* Therapy with Dopamine-modulating substances 21 days prior to start
* Therapy with analgesics for the treatment for pain, unless the dose has been stable
* Chronic alcohol or drug abuse
* Medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the patient's ability to participate in this study
* Hypersensitivity to any components of the Investigational Medicinal Product (IMP) or comparative drugs
* Atypical Parkinson's Disease Syndrome due to drugs
* History of deep brain stimulation
* Significant skin disease that would make transdermal drug use inappropriate
* Electroconvulsive therapy within 12 weeks prior to start
* Evidence of an Impulse Control Disorder
* Previous diagnosis of severe Restless Legs Syndrome
* Chronic Migraine
* Severe Depression
* Symptomatic Orthostatic Hypotension

Primary outcomes:
measure: Change From Baseline to the End of the Maintenance Period in Pain Severity Assessed Using an 11-point Likert Pain Scale
timeFrame: Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after an up to 7 weeks Titration Period)
Secondary outcomes:
measure: Percentage of Responders at the End of the Maintenance Period
timeFrame: Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period)
measure: Change From Baseline to the End of the Maintenance Period in the Sum Score of the 8-Item Parkinson's Disease Questionnaire (PDQ-8)
timeFrame: Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period)
measure: Change From Baseline to the End of the Maintenance Period in the 7-Item Depression Subscore of the Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period)
measure: Change From Baseline to the End of the Maintenance Period in the 7-Item Anxiety Subscore of the Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period)
measure: Change From Baseline to the End of the Maintenance Period in the Combined Score of the Unified Parkinson's Disease Rating Scale (UPDRS) Parts II (Activities of Daily Living [ADL] Subscale) and III (Motor Subscale)
timeFrame: Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period)
measure: Change From Baseline to the End of the Maintenance Period in the 7 Domain Scores of Classification of Pain in Parkinson's Disease
timeFrame: Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period)
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: 2113
state: Arizona
city: Sunnyvale
country: United States
facility: 2120
state: California
city: Tampa
country: United States
facility: 2109
state: Florida
city: Chicago
country: United States
facility: 2107
state: Illinois
city: Lexington
country: United States
facility: 2102
state: Kentucky
city: Advance
country: United States
facility: 2118
state: North Carolina
city: Cincinnati
country: United States
facility: 2117
state: Ohio
city: Tulsa
country: United States
facility: 2103
state: Oklahoma
city: Roanoke
country: United States
facility: 2101
state: Virginia
city: Milwaukee
country: United States
facility: 2104
state: Wisconsin
city: Gera
country: Germany
facility: 1204
city: Gdansk
country: Poland
facility: 1607
city: Krakow
country: Poland
facility: 1603
city: Olsztyn
country: Poland
facility: 1609
city: Bratislava
country: Slovakia
facility: 1804
city: Dubnica Nad Vahom
country: Slovakia
facility: 1805
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: