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


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:

More articles from Health and Medicine:

nachricht Resolving the mystery of preeclampsia
21.10.2016 | Universitätsklinikum Magdeburg

nachricht New potential cancer treatment using microwaves to target deep tumors
12.10.2016 | University of Texas at Arlington

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: New 3-D wiring technique brings scalable quantum computers closer to reality

Researchers from the Institute for Quantum Computing (IQC) at the University of Waterloo led the development of a new extensible wiring technique capable of controlling superconducting quantum bits, representing a significant step towards to the realization of a scalable quantum computer.

"The quantum socket is a wiring method that uses three-dimensional wires based on spring-loaded pins to address individual qubits," said Jeremy Béjanin, a PhD...

Im Focus: Scientists develop a semiconductor nanocomposite material that moves in response to light

In a paper in Scientific Reports, a research team at Worcester Polytechnic Institute describes a novel light-activated phenomenon that could become the basis for applications as diverse as microscopic robotic grippers and more efficient solar cells.

A research team at Worcester Polytechnic Institute (WPI) has developed a revolutionary, light-activated semiconductor nanocomposite material that can be used...

Im Focus: Diamonds aren't forever: Sandia, Harvard team create first quantum computer bridge

By forcefully embedding two silicon atoms in a diamond matrix, Sandia researchers have demonstrated for the first time on a single chip all the components needed to create a quantum bridge to link quantum computers together.

"People have already built small quantum computers," says Sandia researcher Ryan Camacho. "Maybe the first useful one won't be a single giant quantum computer...

Im Focus: New Products - Highlights of COMPAMED 2016

COMPAMED has become the leading international marketplace for suppliers of medical manufacturing. The trade fair, which takes place every November and is co-located to MEDICA in Dusseldorf, has been steadily growing over the past years and shows that medical technology remains a rapidly growing market.

In 2016, the joint pavilion by the IVAM Microtechnology Network, the Product Market “High-tech for Medical Devices”, will be located in Hall 8a again and will...

Im Focus: Ultra-thin ferroelectric material for next-generation electronics

'Ferroelectric' materials can switch between different states of electrical polarization in response to an external electric field. This flexibility means they show promise for many applications, for example in electronic devices and computer memory. Current ferroelectric materials are highly valued for their thermal and chemical stability and rapid electro-mechanical responses, but creating a material that is scalable down to the tiny sizes needed for technologies like silicon-based semiconductors (Si-based CMOS) has proven challenging.

Now, Hiroshi Funakubo and co-workers at the Tokyo Institute of Technology, in collaboration with researchers across Japan, have conducted experiments to...

All Focus news of the innovation-report >>>



Event News

#IC2S2: When Social Science meets Computer Science - GESIS will host the IC2S2 conference 2017

14.10.2016 | Event News

Agricultural Trade Developments and Potentials in Central Asia and the South Caucasus

14.10.2016 | Event News

World Health Summit – Day Three: A Call to Action

12.10.2016 | Event News

Latest News

Resolving the mystery of preeclampsia

21.10.2016 | Health and Medicine

Stanford researchers create new special-purpose computer that may someday save us billions

21.10.2016 | Information Technology

From ancient fossils to future cars

21.10.2016 | Materials Sciences

More VideoLinks >>>