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

CompletedPhase 4NCT01744496
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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 details

Official title
A Multicenter, Multinational, Double-Blind, Placebo-Controlled, 2-Arm Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease-Associated Pain
Conditions
  • Advanced Idiopathic Parkinson's Disease
Interventions
Sponsor
UCB BIOSCIENCES GmbH
Organization
UCB Pharma
Start date
2012-11
Primary completion
2013-12
Sex
All
Age range
from 18 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
Germany, Poland, Slovakia, United States
Total sites listed
16

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01744496