Boehringer drug gives rapid relief in study

The study, part of Boehringer Ingelheim’s ongoing clinical development program to assess the therapeutic potential of pramipexole for the treatment of restless legs syndrome (RLS), demonstrated that a once-daily dose regimen improved RLS symptoms for a 24-hour period. The study also showed that pramipexole had a rapid onset of action and produced significant improvements in patients’ sleep.

The study was designed to evaluate the efficacy and safety of pramipexole in a large population in a clinical setting over a six-week treatment period. The study also included a 46-week extension period to assess the long-term safety and efficacy of treatment.

Results showed that the mean change from baseline to week six in the international RLS rating scale (IRLS scale) of severity was significantly greater for the pramipexole group compared to the placebo group. Moreover, 62.9% of the patients treated with pramipexole were classified as responders (much or very much improved) using the clinical global impressions-improvement (CGI-I) scale at week six compared to 32.5% of the placebo patients.

Sleep disturbance is one of the main features of RLS and often the presenting symptom. Patients were therefore asked to rate the severity of RLS symptoms at the time of getting to sleep as well as their satisfaction with sleep the following morning. Pramipexole-treated patients reported a significantly reduced severity of RLS symptoms while getting to sleep compared to placebo. Overall, satisfaction with sleep was also significantly higher.

Finally, patients were asked to rate the severity of RLS symptoms during the night and the day. The severity of RLS over both periods during pramipexole treatment was decreased significantly compared to placebo after the six-week treatment period. This indicates that a once daily dose regimen with pramipexole has the potential to improve RLS symptoms over a 24-hour time span.

In general, pramipexole was well tolerated, with the most frequent adverse events reported at week six in patients receiving pramipexole being headache (13% versus 9.6 % placebo), nausea (12.2% versus 6.1% placebo) and fatigue (9.1% versus 6.1% placebo).

No medication is currently approved by the FDA for RLS, a common chronic neurological disorder characterized by an uncontrollable urge to move the legs.

Pramipexole, a compound from Boehringer Ingelheim research, was jointly developed by Boehringer Ingelheim and Pharmacia Corp (today Pfizer).