Large Clinical Study Results Show Pramipexole Rapidly Relieves Restless Legs Syndrome Symptoms and Improves Sleep

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NEW ORLEANS, March 8 /PRNewswire/ — The dopamine agonist pramipexole
demonstrated rapid effectiveness and was well-tolerated in the treatment of
Restless Legs Syndrome (RLS), according to study results revealed today from a
large clinical study in RLS patients. Full details were presented during the
9th International Congress of The Movement Disorder Society in New Orleans,
LA. [1]

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 — 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.

Restless Legs Syndrome — a common chronic neurological disorder
characterised by an uncontrollable urge to move the legs — is usually
accompanied by unpleasant and sometimes painful sensations in the legs.
Although RLS affects up to ten percent of the adult population, it is often
unrecognized by sufferers or misdiagnosed by doctors. [2] Approximately
one-third of sufferers experience symptoms more than twice weekly causing
moderate to severe distress. The motor restlessness worsens during the evening
and night causing difficulty initiating and maintaining sleep.

temporarily relieves symptoms, but the resulting sleep disruption can lead to
excessive daytime sleepiness and compromise work performance. The syndrome
also has considerable impact on social activities that require prolonged
sitting, such as working at a desk, going to the movies, making long car
journeys, or dining out.

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.

Patients of at least 18 years of age with idiopathic Restless Legs
Syndrome were randomized to treatment with pramipexole or placebo. Patients
underwent a flexible dose titration phase during weeks one to four (dose
range: 0.125 mg to 0.75 mg daily). A total of 345 patients in five European
countries received treatment. The mean age at RLS onset was 55.5 years and the
mean duration of RLS was 5.2 years.

The 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 (adjusted mean
change from baseline -12.3 versus -5.7, p<0.0001). Moreover, nearly two-thirds
(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 6 compared to 32.5% of the placebo patients (p<0.0001).

Just under one-third of patients (30.6%) treated with pramipexole showed a
Patient Global Impression response (much or very much improved) after one week
on the starting dose of just 0.125 mg per day compared to only 7.0% receiving

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 at baseline and at week 6 using a visual analogue
scale. Pramipexole-treated patients reported a significantly reduced severity
of RLS symptoms while getting to sleep compared to placebo (-30.6 versus
-13.8, p<0.0001). Overall, satisfaction with sleep was also significantly
higher (-29.9 versus -13.8, p<0.0001).

Finally, patients were asked to rate the severity of RLS symptoms during
the night and the day on a visual analogue scale. 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. The most frequent adverse
events reported at week 6 in patients receiving pramipexole were headache (13%
versus 9.6 % placebo), nausea (12.2% versus 6.1% placebo) and fatigue (9.1%
versus 6.1% placebo). Most adverse events were of mild or moderate intensity.
No medication is currently approved by the U.S. Food & Drug Administration
for Restless Legs Syndrome.

About pramipexole

Pramipexole, a compound from Boehringer Ingelheim research, was jointly
developed by Boehringer Ingelheim and Pharmacia Corp. (today Pfizer).
Currently, pramipexole is approved in the U.S. for the treatment of the signs
and symptoms of idiopathic Parkinson's disease, as monotherapy or in
combination with levodopa. The most commonly reported adverse events in early
and late Parkinson's disease in clinical trials were dizziness, dyskinesia,
extrapyramidal syndrome, hallucinations, headache, insomnia, somnolence, and
nausea. In the U.S., Boehringer Ingelheim and Pfizer co-promote Mirapex(R)
(pramipexole) for Parkinson's disease.

Boehringer Ingelheim Pharmaceuticals, Inc.

Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is
the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield,
CT) and a member of the Boehringer Ingelheim group of companies.

The Boehringer Ingelheim group is one of the world's 20 leading
pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates
globally with 152 affiliates in 45 countries and more than 34,000 employees.
Since it was founded in 1885, the family-owned company has been committed to
researching, developing, manufacturing and marketing novel products of high
therapeutic value for human and veterinary medicine.

In 2003, Boehringer Ingelheim posted net sales of US $8.37 billion
(7.4 billion euro) while spending more than one fifth of net sales in its
largest business segment, Prescription Medicines, on research and development.

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[1] Oertel W, Stiasny-Kolster K. Early and persistent effect of
pramipexole in RLS patients already with the starting dose. Movement
Disorders 2005, 20 (Suppl 10): S58.

[2] Abstracts on file with Boehringer Ingelheim and available upon
request. Hening W, Walters AS, Allen RP, Montplaisir J, Myers A,
Ferini-Strambi L. Impact, diagnosis and treatment of restless legs
syndrome (RLS) in a primary care population: the REST (RLS
epidemiology, symptoms, and treatment) primary care study. Sleep Med
2004; 5: 237-246.

SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.

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