Phase 4
Completed N=68
Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease-Associated Pain
Advanced Idiopathic Parkinson's Disease
Source: ClinicalTrials.gov NCT01744496 ↗
Enrolled (actual)
68
Serious AEs
4.4%
Results posted
Dec 2014
Primary outcomePrimary: Change From Baseline to the End of the Maintenance Period in Pain Severity Assessed Using an 11-point Likert Pain Scale — -2.2; -2.8 scores on a scale — p=0.172
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to the End of the Maintenance Period in Pain Severity Assessed Using an 11-point Likert Pain Scale |
-2.2; -2.8 | 0.172 |
| SECONDARY Percentage of Responders at the End of the Maintenance Period |
46.7; 60 | — |
| SECONDARY Change From Baseline to the End of the Maintenance Period in the Sum Score of the 8-Item Parkinson's Disease Questionnaire (PDQ-8) |
-3.77; -12.40 | 0.038 sig |
| SECONDARY Change From Baseline to the End of the Maintenance Period in the 7-Item Depression Subscore of the Hospital Anxiety and Depression Scale (HADS) |
-1.7; -1.9 | 0.247 |
| SECONDARY Change From Baseline to the End of the Maintenance Period in the 7-Item Anxiety Subscore of the Hospital Anxiety and Depression Scale (HADS) |
-1.0; -1.8 | 0.371 |
| SECONDARY 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) |
-5.1; -8.3 | 0.346 |
| SECONDARY Change From Baseline to the End of the Maintenance Period in the 7 Domain Scores of Classification of Pain in Parkinson's Disease |
-1.4; -1.5; -3.1; -0.7; -2.2; -4.2 | — |
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
Data sourced from ClinicalTrials.gov (NCT01744496). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.