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

UCB

Status and phase: Completed; Phase 4

Conditions: Advanced Idiopathic Parkinson's Disease

Treatments: Drug: Rotigotine; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01744496

PD0004

2012-002608-42 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 68 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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68 participants in 2 patient groups, including a placebo group

Rotigotine

Experimental group

Description:

Rotigotine Transdermal Patches

Treatment:

Drug: Rotigotine

Placebo

Placebo Comparator group

Description:

Placebo Transdermal Patches

Treatment:

Drug: Placebo