NCT01744496CompletedPhase 4
A Multicenter, Multinational, Double-Blind, Placebo-Controlled, 2-Arm Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease-Associated Pain
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- UCB BIOSCIENCES GmbH
- Enrollment
- 68
- Locations
- 16
- Primary Endpoint
- Change From Baseline to the End of the Maintenance Period in Pain Severity Assessed Using an 11-point Likert Pain Scale
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Rotigotine
Experimental
Rotigotine Transdermal Patches
Intervention: Rotigotine (Drug)
Placebo
Placebo Comparator
Placebo Transdermal Patches
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Change From Baseline to the End of the Maintenance Period in Pain Severity Assessed Using an 11-point Likert Pain Scale
Time Frame: Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after an up to 7 weeks Titration Period)
An 11-Point Likert Scale was used to assess patients' average daily pain. The subject rated his/her average pain from 0 (no pain) to 10 (worst pain ever experienced). The average pain experienced in the last 7 days was calculated by the mean of the daily Likert Pain Scores within the 7 days prior to the respective visit (ie, Likert Pain Scores with a date of assessment before the date of visit and on or after the date of visit - 7 days). A negative value indicates an improvement.
Secondary Outcomes
- Percentage of Responders at the End of the Maintenance Period(Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period))
- Change From Baseline to the End of the Maintenance Period in the 7-Item Depression Subscore of the Hospital Anxiety and Depression Scale (HADS)(Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period))
- Change From Baseline to the End of the Maintenance Period in the Sum Score of the 8-Item Parkinson's Disease Questionnaire (PDQ-8)(Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period))
- Change From Baseline to the End of the Maintenance Period in the 7-Item Anxiety Subscore of the Hospital Anxiety and Depression Scale (HADS)(Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period))
- Change From Baseline to the End of the Maintenance Period in the 7 Domain Scores of Classification of Pain in Parkinson's Disease(Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period))
- 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)(Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period))
Investigators
Study Sites (16)
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