Phase 4
Completed N=349
Placebo-controlled Study in Patients With Parkinson's Disease to Evaluate the Effect of Rotigotine on Non-motor Symptoms
Source: ClinicalTrials.gov NCT01300819 ↗Enrolled (actual)
349
Serious AEs
3.5%
Results posted
May 2014
Primary outcomePrimary: Change From Baseline to the End of Maintenance in Total Nonmotor Symptoms Scale (NMSS) Score — -19.1; -23.1 scores on a scale — p=0.147
Summary
The primary objective of this study was to demonstrate that Rotigotine improves non-motor symptoms compared to Placebo in subjects with Parkinson's Disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to the End of Maintenance in Total Nonmotor Symptoms Scale (NMSS) Score |
-19.1; -23.1 | 0.147 |
| SECONDARY Change From Baseline to the End of Maintenance in Total Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score |
-3.6; -5.7 | 0.002 sig |
| SECONDARY Change From Baseline to the End of Maintenance in Health-related Quality of Life (HRQL) Measured by a 39-item Parkinson's Disease Questionnaire (PDQ-39) |
-2.6; -5.9 | 0.024 sig |
| SECONDARY Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Cardiovascular |
-1.2; -1.1 | 0.773 |
| SECONDARY Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Sleep/Fatigue |
-3.9; -5.4 | 0.122 |
| SECONDARY Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Mood/Cognition |
-5.1; -6.6 | 0.047 sig |
| SECONDARY Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Perception/Hallucinations |
-0.2; -0.2 | 0.601 |
| SECONDARY Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Attention/Memory, |
-1.3; -1.5 | 0.997 |
| SECONDARY Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Gastrointestinal Tract |
-1.4; -1.6 | 0.584 |
| SECONDARY Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Urinary |
-2.7; -2.4 | 0.536 |
| SECONDARY Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Sexual Function |
-1.2; -1.1 | 0.889 |
| SECONDARY Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Miscellaneous |
-2.2; -3.2 | 0.043 sig |
Eligibility Criteria
Inclusion Criteria
- Subject is male or female, ≥18 years of age
- Subject has idiopathic Parkinson's disease with at least 2 of the following cardinal signs being present: bradykinesia, resting tremor, rigidity or postural instability, and without any other known or suspected cause of Parkinsonism
- Subject has a Hoehn and Yahr stage score ≤4
- Subject has a total Non-Motor Symptoms Scale (NMSS) score ≥40
- If the subject is taking levodopa (L-DOPA), he/she must be on a stable dose of L-DOPA (in combination with benserazide or carbidopa) for at least 28 days prior to the Baseline Visit
- If the subject is receiving anticholinergics, monoamine oxidase (MAO) B inhibitors, or amantadine, he/she must have been on a stable dose for at least 28 days prior to the Baseline Visit and must be maintained on that dose for the duration of the study
Exclusion Criteria
- Subject discontinued from previous therapy with a dopamine agonist after an adequate length of treatment, at an adequate dose, due to lack of efficacy as assessed by the investigator
- Subject is receiving therapy with 1 of the following drugs, either concurrently or within 28 days prior to the Baseline Visit: alpha-methyl dopa, metoclopramide, reserpine, neuroleptics (except specific atypical neuroleptics: olanzapine, ziprasidone, aripiprazole, clozapine, and quetiapine), monoamine oxidase-A (MAO-A) inhibitors, methylphenidate, amphetamine, or other dopamine agonists (DAs)
- Subject is receiving central nervous system (CNS) therapy (eg, sedatives, hypnotics, selective serotonin reuptake inhibitors [SSRIs], anxiolytics, or other sleep-modifying medication) unless dose has been stable daily for at least 28 days prior to the Baseline Visit and is likely to remain stable for the duration of the study
- Subject has evidence of an impulse control disorder according to the modified Minnesota Impulsive Disorders Interview at the Screening Visit (Visit 1), confirmed by a positive structured clinical interview
Data sourced from ClinicalTrials.gov (NCT01300819). 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.