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New Data Presented at the American Academy of Neurology Meeting Showed That Neupro(R) (Rotigotine Transdermal System) Improved B

Posted Apr 20 2010 11:10am

At the 62nd American Academy of Neurology annual meeting in Toronto, Canada last week evidence was presented that showed improvement in motor and non-motor symptoms of Parkinson’s Disease.  This report is reproduced from PD ONLINE RESEARCH .

“The new data reported this week showed that treatment with rotigotine controlled early morning motor function and improved non-motor symptoms, as judged by the validated non-motor scale, in patients with Parkinson’s disease and these effects translated into improvements in quality of life for our patients. RECOVER is the first study carried out in a controlled setting that addresses the non-motor symptoms of Parkinson’s disease, such as sleep, mood, cognition and pain, which can be just as debilitating to patients as the more obvious movement disorder,” said Professor Ray Chaudhuri, Consultant Neurologist and Professor in Neurology and Movement Disorders at Kings College NHS Foundation Trust, and Kings Health Partners, London, UK.

These new findings were reported in extensive analyses of data from RECOVER – a multicentre, multinational, double-blind, placebo-controlled study designed to assess the effects of rotigotine in controlling early morning motor function and non-motor symptoms that affect the everyday lives of people with Parkinson’s disease.

Of the 287 Parkinson’s patients in RECOVER, 190 were randomized to rotigotine and 97 to placebo. The dose of rotigotine or placebo was tailored to individual patient need (2-16mg/24h or placebo) during a titration period lasting up to 8 weeks, followed by a 4 week maintenance period.

Early morning motor function was assessed using the Unified Parkinson’s Disease Rating Scale (UPDRS) Part III (Motor Examination) and sleep quality was assessed using the Parkinson’s Disease Sleep Scale (PDSS). Patients were hospitalized for 2 nights before assessment at baseline and again at the end of the maintenance period. The co-primary efficacy endpoints were the mean change from baseline to end of maintenance in PDSS and UPDRS Part III scores. Non-motor symptoms were assessed as secondary outcomes.

Key primary and secondary outcomes from baseline to end of maintenance were:

Motor symptoms and primary efficacy endpoints

Rotigotine provided significantly greater improvement in early morning motor symptoms than placebo (-7.0 vs -3.9 points; treatment difference -3.55; p=0.0002) as measured by the UPDRS Part III (Motor Examination), a comprehensive, widely used evaluation of motor symptoms as well as cognition, behavior and mood. Rotigotine also provided significantly greater improvement than placebo in sleep quality scores as measured by the PDSS (-5.9 vs -1.9 points; difference -4.26; p<0.0001).

Non-motor symptoms

  • Overall patients experienced greater improvements in non-motor symptoms with rotigotine than placebo (-11.4 vs -6.3 points; treatment difference -6.65; p=0.015), as measured by the Parkinson’s disease Non-Motor Symptoms assessment scale total (NMST), which measures the severity and frequency of 9 categories of non-motor symptoms, including cardiovascular, sleep/fatigue, mood/cognition and attention/memory
  • Rotigotine provided greater improvement than placebo in sleep/fatigue (treatment difference -2.03; p=0.002) and in mood/cognition (treatment difference -3.40; p=0.0003) as measured by the NMST
  • Rotigotine provided greater improvement than placebo in mood (treatment difference  -2.01; p=0.011) as measured by the Beck Depression Inventory (BDI-II), a widely used questionnaire developed to measure the intensity, severity and depth of depression
  • Rotigotine provided greater improvement than placebo in quality of life (treatment difference -5.74, p=0.0002) as measured by PDQ-8, a short form Parkinson’s disease questionnaire
  • Rotigotine provided greater improvement than placebo in pain (treatment difference -0.77, p=0.004) as measured by the Likert scale
  • There was no change in the number of nocturias (excessive urination at night) in either the rotigotine or placebo group

Tolerability

The most frequently reported adverse events were nausea (rotigotine 21%, placebo 9%), application site reactions (rotigotine 15%, placebo 4%) and dizziness (rotigotine 10%, placebo 6%).

Tolerability and efficacy of rotigotine up to 6 years demonstrated in early stage Parkinson’s disease

Rotigotine was generally well tolerated and provided sustained improvement in movement symptoms in patients with early Parkinson’s disease treated for up to 6 years, according to new data from an open label extension of an earlier double blind trial, also presented at AAN.

Of 216 patients who received treatment during the open label phase, more than half (52%) received at least 5 years of rotigotine treatment. Overall, 24% of patients discontinued due to adverse events, of which the most frequently reported (rate per patient-year) were somnolence (23% per patient-year), peripheral edema (14% per patient-year) and fall (17% per patient-year). Treatment-emergent application site reactions were reported in 70 (32%) of patients during open label treatment (12% per patient-year). Mean UPDRS (II + III) scores after up to 6 years of rotigotine treatment remained within 4 points of patients’ original double-blind baseline scores.

Long-term efficacy and tolerability of rotigotine in advanced Parkinson’s disease

Continued efficacy and tolerability were also reported in long-term follow up studies of over 600 patients who enrolled in open label extensions of 2 previous double blind trials of rotigotine in advanced Parkinson’s disease.

A 4-year open label extension trial enrolled 395 patients. While UPDRS Activities of Daily Living (ADL) mean total score improved from double-blind baseline by -4.5 points during the open label titration to rotigotine 4-16mg/24h, it gradually returned to baseline values (+0.8 points) over 4 years.  The mean UPDRS Motor Score (MS) improved from double-blind baseline by -10.1 points during titration then gradually declined to -2.8 points of improvement.

Of 258 patients who entered the open label phase of a second study, 68 (26%) withdrew by the end of year 6 because of adverse events. The -4.9-point mean ADL score improvement achieved during titration declined to +4.1 points above baseline over 6 years, and the mean MS declined from an initial -11.4-point improvement to baseline values (-0.2 points). Treatment-emergent adverse effects were typically dose-related dopaminergic effects such as insomnia (5–7% per patient-year), dyskinesias (4–8% per patient-year), and hallucinations (4–8% per patient-year).

For further information

Onsite at meeting

Andrea Levin / Public Relations Manager, CNS, UCB, Inc.

Office:  770.970.8352 / Mobile: 404.483.7329 / Email: andrea.levin@ucb.com


Filed under: Clinical Trials , Drug manufacturers , Early Onset Parkinson's Disease , Medical research , Neupro Patch , Parkinson's Disease , Restless Leg Syndrome , UCB-Schwarz Pharma Tagged: Neupro Patch; UCB Schwarz Pharma; Parkinson's Disease , Rotigotine
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