Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

Pramipexole delivered sustained efficacy in clinical trial of patients with Restless Legs Syndrome

12.12.2005


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!
Further information:
http://www.ketchum.com
http://us.boehringer-ingelheim.com

More articles from Health and Medicine:

nachricht Antibiotic effective against drug-resistant bacteria in pediatric skin infections
17.02.2017 | University of California - San Diego

nachricht Tiny magnetic implant offers new drug delivery method
14.02.2017 | University of British Columbia

All articles from Health and Medicine >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: Breakthrough with a chain of gold atoms

In the field of nanoscience, an international team of physicists with participants from Konstanz has achieved a breakthrough in understanding heat transport

In the field of nanoscience, an international team of physicists with participants from Konstanz has achieved a breakthrough in understanding heat transport

Im Focus: DNA repair: a new letter in the cell alphabet

Results reveal how discoveries may be hidden in scientific “blind spots”

Cells need to repair damaged DNA in our genes to prevent the development of cancer and other diseases. Our cells therefore activate and send “repair-proteins”...

Im Focus: Dresdner scientists print tomorrow’s world

The Fraunhofer IWS Dresden and Technische Universität Dresden inaugurated their jointly operated Center for Additive Manufacturing Dresden (AMCD) with a festive ceremony on February 7, 2017. Scientists from various disciplines perform research on materials, additive manufacturing processes and innovative technologies, which build up components in a layer by layer process. This technology opens up new horizons for component design and combinations of functions. For example during fabrication, electrical conductors and sensors are already able to be additively manufactured into components. They provide information about stress conditions of a product during operation.

The 3D-printing technology, or additive manufacturing as it is often called, has long made the step out of scientific research laboratories into industrial...

Im Focus: Mimicking nature's cellular architectures via 3-D printing

Research offers new level of control over the structure of 3-D printed materials

Nature does amazing things with limited design materials. Grass, for example, can support its own weight, resist strong wind loads, and recover after being...

Im Focus: Three Magnetic States for Each Hole

Nanometer-scale magnetic perforated grids could create new possibilities for computing. Together with international colleagues, scientists from the Helmholtz Zentrum Dresden-Rossendorf (HZDR) have shown how a cobalt grid can be reliably programmed at room temperature. In addition they discovered that for every hole ("antidot") three magnetic states can be configured. The results have been published in the journal "Scientific Reports".

Physicist Dr. Rantej Bali from the HZDR, together with scientists from Singapore and Australia, designed a special grid structure in a thin layer of cobalt in...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

Booth and panel discussion – The Lindau Nobel Laureate Meetings at the AAAS 2017 Annual Meeting

13.02.2017 | Event News

Complex Loading versus Hidden Reserves

10.02.2017 | Event News

International Conference on Crystal Growth in Freiburg

09.02.2017 | Event News

 
Latest News

Biocompatible 3-D tracking system has potential to improve robot-assisted surgery

17.02.2017 | Medical Engineering

Real-time MRI analysis powered by supercomputers

17.02.2017 | Medical Engineering

Antibiotic effective against drug-resistant bacteria in pediatric skin infections

17.02.2017 | Health and Medicine

VideoLinks
B2B-VideoLinks
More VideoLinks >>>