Preclinical Tests Look Good for New Parkinson's Drug

Health-related quality of life gets thumbs up

/ Author:  / Reviewed by: Joseph V. Madia, MD

In a study, people with Parkinson's who used once-daily Neupro (rotigotine) achieved improvements in quality of life, in addition to previously reported beneficial effects on motor and non-motor symptoms.

Data presented this week at the 2nd World Parkinson Congress in Glasgow, UK, showed that in the RECOVER trial, subjects who were administered Neupro® displayed clinically relevant improvements in PDQ-8 score (a self-administered health-related quality of life questionnaire comprising eight items – mobility, activities of daily living, emotional well-being, social support, cognition, communication, bodily discomfort and stigma).

"Data from the RECOVER trial demonstrated improvements in motor and non-motor symptoms for people living with Parkinson's disease as well as worthwhile changes in the quality of their everyday lives, including their daily activities, their emotional well being and their cognitive and communication abilities," said Herve Lilliu, Head of Health Outcomes and Access, UCB.

The RECOVER trial was a multicenter, 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 early- and late-stage Parkinson's disease. Patients were randomized to receive rotigotine or placebo during a titration period lasting up to 8 weeks, followed by a 4-week maintenance period.

PDQ-8 data were obtained from measurements taken at baseline and at the end of the 12 week study from 89 placebo- and 176 rotigotine-randomized patients. Mean change from baseline PDQ-8 total score was greater in the rotigotine group than the placebo group.

In a study of Asian patients, the PDQ-8 minimal important difference (MID) – defined as the smallest difference in score that informed patients/proxies would perceive as important and would lead the patient or clinician to consider a change in therapy – has been shown to range from 5.8-7.4 points.

"The change from baseline in PDQ-8 score in the rotigotine group was within the previously established MID range, suggesting that patients in the current study would consider the improvement in health-related quality of life (HRQL) achieved by rotigotine to be important. The effect sizes indicate that the PDQ-8 is a responsive instrument and that rotigotine has a clinically relevant effect on HRQL," concluded Mr. Lilliu.

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%). In general, adverse drug reactions reported in more than 10% of Parkinson's patients treated with Neupro are nausea, vomiting, application site reactions, somnolence, dizziness and headache.

Preclinical data showed rotigotine increased depth of sleep in rats

Preclinical data presented at the Congress showed that continuous administration of rotigotine or pulsatile L-DOPA had beneficial effects on wakefulness and sleep patterns in a rat model of Parkinson's disease, but only continuous rotigotine decreased the ratio of alpha to delta wave sleep during slow wave sleep, indicative of increased depth of sleep. To date the clinical significance of this finding has not been established.

The study was carried out to investigate the effects of rotigotine and pulsatile L-DOPA on sleep-wake patterns in a preclinical rat model of Parkinson's disease.

After two days of baseline recording, the study compared the effects of rotigotine administered as a slow-release formulation of 0.5 or 5 mg/kg every second day for 6 days and L-DOPA/benserazide administered daily at 10/7.5 mg/kg s.c., for 6 days in 6-OHDA lesioned rats.

Latency to slow wave sleep (SWS) and paradoxical sleep (REM) onset, duration of waking, SWS and REM sleep and the alpha and delta frequency ratio during SWS were analyzed off-line. No effects were seen with low dose rotigotine or with a placebo vehicle. Pulsatile L-DOPA and continuous rotigotine at 5 mg/kg caused an increase in active waking and a decrease in SWS duration. While L-DOPA had no effect on the alpha/delta power ratio, the high dose of continuous rotigotine decreased the alpha/delta ratio towards an increase in delta power during SWS.

For further information
Eimear O Brien, Associate Director, Global CNS Communications
T +32 2 559 9271, [email protected]
Andrea Levin, Senior Manager, Communications & PR, CNS, UCB, Inc.
Office: 770.970.8352 / Mobile: 404.483.7329 / Email: [email protected]

Reviewed by: 
Review Date: 
September 30, 2010
Last Updated:
October 1, 2010