Pramipexole delivered sustained efficacy in clinical trial of patients with Restless Legs Syndrome
Two large, randomised, placebo-controlled studies presented at the inaugural conference of the World Association of Sleep Medicine (WASM; Berlin, Germany) in October demonstrate that pramipexole delivered both short-term and sustained efficacy in patients suffering from Restless Legs Syndrome (RLS)1,2 enrolled in these trials.
New data from a randomized, placebo-controlled "withdrawal" study1 show that discontinuation of pramipexole leads to rapid worsening of RLS in patients who had previously responded well to pramipexole therapy. In this study, RLS patients who responded to pramipexole treatment in a preceding 6-month open label treatment phase were randomized to receive either blinded pramipexole (n=78) or placebo (n=69) for 12 weeks. The primary endpoint of the study was assessment of Time to Worsening of RLS symptoms measured using the International RLS Rating Scale (IRLS) and the Clinical Global Impressions – Global Improvement (CGI-I) scale. The results showed:
- RLS patients who were randomized to continue treatment with pramipexole experienced a significantly longer time before their symptoms worsened than those patients who were randomised to placebo (p<0.0001)
- The proportion of patients that experienced worsening of their RLS symptoms in the blinded pramipexole group was statistically significantly smaller compared to those randomized to receive placebo (pramipexole 20.5 percent vs. placebo 85.5 percent; p<0.0001)
- One week after randomization, more than 70.0 percent of patients on placebo worsened as compared to just 9.0 percent of patients in the blinded pramipexole group
- Pramipexole also significantly improved the disease-specific quality of life score to 90 percent (70 percent for placebo; p<0.0001)
In addition, in a fixed-dose study pramipexole demonstrated significant improvement in symptoms of RLS, when measured by two standard clinical assessment tools, when compared to placebo.2 This 12-week, placebo-controlled, randomized study sought to compare the efficacy and safety of pramipexole at different doses (0.25mg; 0.5mg and 0.75mg) when compared to placebo. After 12 weeks, patients who received pramipexole - across all three doses - experienced significantly greater improvements in symptoms of RLS compared to placebo. Three hundred and forty five patients were randomized and 339 patients were assessed at the end of 12 weeks for improvement in RLS symptoms using the IRLS and CGI-I scales.
- IRLS scores at week 12 demonstrated that across all three pramipexole doses the IRLS score was significantly improved for patients when compared to placebo
- CGI-I scores also demonstrated that significantly more patients who received pramipexole treatment reported themselves as much improved or very much improved at the end of 12 weeks of treatment compared to patients treated with placebo
In both studies pramipexole was generally well-tolerated and the most frequent adverse events were nausea, headache and fatigue.
Previous studies in RLS have reported rapid, statistically significant effects of pramipexole on RLS symptoms. The efficacy and safety of pramipexole for treatment of RLS has been studied from a starting dose of 0.125mg single dose per day and up to 0.75mg single dose per day.
These trials are part of a comprehensive clinical trial program, involving more than 1,000 patients, to assess the therapeutic potential of pramipexole in the treatment of RLS. Boehringer Ingelheim, the discoverer of the molecule, has also recently submitted applications for international regulatory approval of pramipexole in the treatment of RLS.
Anne Marie Kearns | EurekAlert!
The most recent press releases about innovation >>>
Die letzten 5 Focus-News des innovations-reports im Überblick:
An international team of scientists has proposed a new multi-disciplinary approach in which an array of new technologies will allow us to map biodiversity and the risks that wildlife is facing at the scale of whole landscapes. The findings are published in Nature Ecology and Evolution. This international research is led by the Kunming Institute of Zoology from China, University of East Anglia, University of Leicester and the Leibniz Institute for Zoo and Wildlife Research.
Using a combination of satellite and ground data, the team proposes that it is now possible to map biodiversity with an accuracy that has not been previously...
Heatwaves in the Arctic, longer periods of vegetation in Europe, severe floods in West Africa – starting in 2021, scientists want to explore the emissions of the greenhouse gas methane with the German-French satellite MERLIN. This is made possible by a new robust laser system of the Fraunhofer Institute for Laser Technology ILT in Aachen, which achieves unprecedented measurement accuracy.
Methane is primarily the result of the decomposition of organic matter. The gas has a 25 times greater warming potential than carbon dioxide, but is not as...
Hydrogen is regarded as the energy source of the future: It is produced with solar power and can be used to generate heat and electricity in fuel cells. Empa researchers have now succeeded in decoding the movement of hydrogen ions in crystals – a key step towards more efficient energy conversion in the hydrogen industry of tomorrow.
As charge carriers, electrons and ions play the leading role in electrochemical energy storage devices and converters such as batteries and fuel cells. Proton...
Scientists from the Excellence Cluster Universe at the Ludwig-Maximilians-Universität Munich have establised "Cosmowebportal", a unique data centre for cosmological simulations located at the Leibniz Supercomputing Centre (LRZ) of the Bavarian Academy of Sciences. The complete results of a series of large hydrodynamical cosmological simulations are available, with data volumes typically exceeding several hundred terabytes. Scientists worldwide can interactively explore these complex simulations via a web interface and directly access the results.
With current telescopes, scientists can observe our Universe’s galaxies and galaxy clusters and their distribution along an invisible cosmic web. From the...
Temperature measurements possible even on the smallest scale / Molecular ruby for use in material sciences, biology, and medicine
Chemists at Johannes Gutenberg University Mainz (JGU) in cooperation with researchers of the German Federal Institute for Materials Research and Testing (BAM)...