Detailed RECOVER trial analysis presented at major international congress
Brussels (Belgium), 17th June 2010, 1430 CET - New data presented this week at the 14th International Congress of Parkinson's Disease and Movement Disorders in Buenos Aires, Argentina (June 13-17, 2010) showed that Neupro® (rotigotine) provided significantly greater improvement in early morning motor symptoms and sleep quality, compared with placebo, and as measured by the Unified Parkinson's Disease Rating Scale and the Parkinson's Disease Sleep Scale. [1],[2]

The latest data come from an analysis from the RECOVER study - 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.

"Sleeping without being restless, uncomfortable or immobile during the night may be just as important to people with Parkinson's disease, as being able to move around during the day" said Professor Claudia Trenkwalder from the Paracelsus-Elena Hospital, Kassel, Germany. "Findings from the RECOVER study showed that rotigotine was an effective treatment option for patients with Parkinson's disease having beneficial effects on both motor and non-motor symptoms."

About the RECOVER trial analysis
Of the 287 patients with idiopathic Parkinson's disease and unsatisfactory early morning motor control 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. Patients were hospitalized for two nights before assessment at baseline and again at the end of the maintenance period.

Early morning motor function was assessed from baseline to the end of maintenance using the Unified Parkinson's Disease Rating Scale (UPDRS) Part III (Motor Examination), a comprehensive, widely used evaluation of motor symptoms. Additional exploratory endpoints were the UPDRS Part II (Activities of Daily Living) and Part II+III scores, assessed from baseline to end of treatment. Responder rates were also assessed, with responders defined as people with a) ≥ 20% and b) ≥ 30% improvements in UPDRS Part III score from baseline to end of maintenance.

Sleep quality was assessed using the modified Parkinson's Disease Sleep Scale (PDSS-2) from baseline to end of maintenance. The PDSS-2 assesses sleep disturbance, nocturnal motor and non-motor symptoms. Mean changes in PDSS-2 domain and individual item scores were additional exploratory endpoints.

The co-primary efficacy endpoints were the mean change from baseline to end of maintenance in PDSS-2 and UPDRS Part III scores.

Primary efficacy endpoints [1],[2]
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). Rotigotine also provided significantly greater improvement than placebo in sleep quality scores as measured by the PDSS-2 total score (-6.08 vs -2.45 points; treatment difference -4.26; p<0.0001).

Additional exploratory endpoints [1],[2]
Improvement in PDSS-2 score for disturbed sleep was significantly better with rotigotine than placebo (treatment difference -1.4 points; p=0.0009),and within this domain, scores were better for difficulty falling asleep (treatment difference -0.46 points; p=0.0008) and feeling tired and sleepy in the morning (treatment difference -0.4 points; p=0.0036). No significant differences were seen for poor sleep quality, difficulty staying asleep or need to get up and pass urine.
PDSS-2 scores for motor symptoms at night were significantly better with rotigotine than placebo (treatment difference -1.54 points; p<0.0001), and within this domain, scores were better for restlessness of legs or arms (treatment difference-0.36 points; p=0.0025), urge to move legs or arms (treatment difference -4.3 points;p=0.0003), painful posturing in the morning (treatment difference -0.34 points); p=0.0027) and tremor on waking (treatment difference -0.33 points; p=0.0153). The only item not to show a significantly greater improvement with rotigotine was distressing dreams.
Patients had fewer PD symptoms at night with rotigotine than placebo, according to PDSS-2 domain scores (-1.41 points; p<0.0001), and within this domain, scores were better for feeling uncomfortable and immobile (-0.49 points; p<0.0001), pain in arms or legs (-0.36; p=0.001), muscle cramps in arms or legs (-0.31; p=0.0067), and breathing difficulties or snoring (-0.24; p=0.0064). Only scores for distressing hallucinations showed no difference between the two groups.
Patients experienced significantly greater improvements in UPDRS Part II (Activities of Daily Living) with rotigotine than placebo (-2.6 vs -1.3 points; treatment difference -1.49; p=0.0005), and significantly greater improvements in Part II+III scores (-9.6 vs -5.2 points; treatment difference -4.95; p<0.0001).
UPDRS Part III responder rates were higher with rotigotine than placebo (≥ 20% improvement: rotigotine 52%, placebo 33%; ≥ 30% improvement: rotigotine 38%, placebo 19%).

In the RECOVER study, 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%). [3]