Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease-Associated Pain

UCB BIOSCIENCES GmbH68 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Advanced Idiopathic Parkinson's Disease

Interventions

RotigotineDRUG

Patches will contain 4 mg / 24 h (20 cm\^2), 6 mg/ 24 h (30 cm\^2), or 8 mg /24 h (40 cm\^2) of Rotigotine. Application of study medication starts at the Baseline Visit. Rotigotine will be administered once daily starting at 4 mg / 24 h. Doses will then be up-titrated in weekly increments of 2 mg / 24 h until optimal or maximum dose (16 mg / 24 h) is reached and the Maintenance Period can be started. The duration of the Titration Period will vary from 1 to 7 weeks ± 3 days. The Maintenance Period will last 12 weeks ± 5 days. Thereafter, during the De-escalation Period, the dose of study medication will be decreased by 2 mg / 24 h every other day. The De-escalation Period may last up to 12 days.

PlaceboDRUG

Placebo patches match the size of active patches 20 cm\^2, 30 cm\^2, or 40 cm\^2 and will contain Placebo. Application of Placebo patches starts at the Baseline Visit. Placebo patches will be administered once daily starting with the equivalent of 4 mg / 24 h. Doses will then be up-titrated in weekly equivalents to 2 mg / 24 h until either optimal dose or maximum dose is reached. The maximum dose is the equivalent to 16 mg / 24 h. The duration of the Titration Period will vary from 1 to 7 weeks. The Maintenance Period will last 12 weeks ± 5 days. During the De-escalation Period, the dose of Placebo will be decreased by the equivalent to 2 mg / 24 h every other day. The De-escalation Period may last up to 12 days.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (16)

2113

Gilbert, Arizona, United States

2120

Sunnyvale, California, United States

2109

Tampa, Florida, United States

Outcomes

Primary Outcomes

Change From Baseline to the End of the Maintenance Period in Pain Severity Assessed Using an 11-point Likert Pain Scale

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.

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)

Secondary Outcomes

Percentage of Responders at the End of the Maintenance Period

Responders are defined as patients experiencing a 2-Point or more Reduction on an 11-Point Likert Pain Scale from Baseline to the End of the Maintenance Period. An 11-Point Likert Scale was used to assess patients' average daily pain. The patient rated his/her average pain from 0 (no pain) to 10 (worst pain ever experienced).

Time frame: 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)

The 8-Item Parkinson's Disease Questionnaire (PDQ-8) (Peto et al, 1998) is a self-administered questionnaire that provides a reliable measure of overall health status. The PDQ-8 contains 8 items of daily living, with 1 item selected from each of the following 8 scales: mobility, Activities of Daily Living (ADL), emotional well being, stigma, social support, cognitions, communication, and bodily discomfort. The total PDQ-8 score is the sum of all the individual items converted to a summary index score between 0 and 100, with lower scores indicating better health. A negative value indicates an improvement.

Time frame: Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period)

Data from ClinicalTrials.gov

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