Posted by: Thixia | April 2, 2008

Restless Leg Syndrome, Drug Trial Patch

Improvements over 24 Months in Patients with Moderate to Severe Idiopathic Restless Legs Syndrome Treated with a Rotigotine Transdermal Patch –

OBJECTIVE:

This trial is an open label extension of a six-arm, double-blind, prospective, placebo-controlled, 7 week, dose-finding study in 33 centers in Europe. The aim of this trial is to determine safety, tolerability and efficacy of long-term application in subjects with moderate to severe idiopathic RLS.

BACKGROUND:

Rotigotine, a non-ergolinic (potent alkaloid) D3/D2/D1 dopamine agonist formulated as a once-daily transdermal  (patch) delivery system, is licensed in Europe for the treatment of early stage Parkinson’s disease and in development for RLS. The patch technology releases the drug continuously, and provides stable plasma levels over 24 hours.

DESIGN/METHODS:

After the optimal dose titration period, rotigotine is administered with dose-adjustments allowed at anytime to maintain optimal treatment. Data are presented assessing the 24 months follow-up after the titration period. Efficacy variables included IRLS total score, CGI, and RLS-6 scales.

RESULTS:

A total of 295 patients entered the open-label extension trial and 191 completed the 2-years. The baseline

IRLS score was 27.8 5.9 and optimal dose treatment resulted in a reduction of 17.2 9.2 points. A similar response was observed, when the

RLS-6 scales were analyzed with reductions of -4.0 3.1, -4.93.0, -4.3 3.3, and -2.4 2.7 for the items at bedtime falling asleep, during the night, sleep satisfaction, and daytime tiredness and sleepiness, respectively.  Compared to the condition at baseline, the CGI score item 1 severity of illness was reduced at -2.8 + 1.19.

Item 2 change of condition showed a sustained improvement at 1.4 + 0.6.

The most common adverse events (>10%) were application site reactions (50%), nasopharyngitis (12%), back pain (11%), and nausea (11%). No clinical signs and symptoms of augmentation were reported.

CONCLUSIONS/RELEVANCE:

Treatment with the rotigotine patch was well-tolerated, safe and showed clinically relevant improvement in the IRLS, CGI, and RLS-6 scores. All improvements were observed in the titration period and were sustained during 24 months follow-up.

Supported by: Schwarz- Pharma.

Category – Sleep Disorders

SubCategory – Restless Leg Syndrome

This information was published in the 59th Annual Meeting of the American Academy of Neurology.  It was published Thursday, May 3, 2007.

This is the latest data that I can find on this patch.  If you have any information let me know. 

Results were  from a Multi-National, Multi-Centre, Open-Label, Follow-Up Trial.

By:

Claudia Trenkwalder, Kassel, Germany,

Diego Garcia-Borreguero, Madrid, Spain,

Werner Poewe, Innsbruck, Austria,

Erwin Schollmayer, Monheim, Germany,

Wolfgang Oertel, Marburg, Germany

The American Academy of Neurology (AAN), established in 1948, is an international professional association of more than 21,000 neurologists and neuroscience professionals dedicated to providing the best possible care for patients with neurological disorders. The AAN is strongly committed to its mission and focuses its efforts on ensuring the reality of the principles and standards set forth in the AAN mission statement.

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