Healthcare Industry News:  pramipexole 

Biopharmaceuticals Neurology

 News Release - October 31, 2006

Boehringer Ingelheim Launches PROUD Study to Explore Possible Disease-Modifying Effect of Pramipexole

Results - expected in 2008 - may inform future treatment practices

RIDGEFIELD, Conn., Oct. 31 (HSMN NewsFeed) -- A global clinical trial has been launched by Boehringer Ingelheim to assess the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new or recently diagnosed cases of Parkinson's disease. Efficacy will be determined by the change in parts I, II and III of the Unified Parkinson's Disease Rating Scale (UPDRS) at 15 months relative to baseline. An important goal of this study is to explore the potential benefit of earlier initiation of treatment of Parkinson's disease with pramipexole in relation to the development of motor complications of the disease. The protocol for the trial, Assessment of Potential Impact of pramipexole On Underlying Disease (PROUD), was presented today at the 10th International Congress of Parkinson's Disease and Movement Disorders (MDS) in Kyoto, Japan.

"Currently, our practice is to initiate drug therapy for Parkinson's disease when symptoms cause disability that necessitates treatment," stated Kenneth Marek, MD, Institute for Neurodegenerative Disorders. "The results from this study will help us understand how best to help newly diagnosed patients, and may cause us to change the way we use pramipexole to treat early Parkinson's disease."

This multinational randomized, double-blind, placebo-controlled, parallel-group clinical trial is being conducted at trial sites in the United States, Europe, South Africa and Japan and is part of an ongoing group of studies. Criteria for inclusion in the clinical trial mandate that male and female participants be between the ages of 30-75 and newly diagnosed with idiopathic Parkinson's disease. These participants must have at least three of the following signs of Parkinson's disease: resting tremor, bradykinesia (slowed movement), rigidity, and asymmetry, and must not require PD medication for at least six months.

The clinical trial will last for 15 months, during which participants will be divided into two groups of 250. For the first nine months, one group will receive a placebo, the other group will receive pramipexole. For the remainder of the 15-month study, both groups will receive pramipexole. Results are expected from 2008 onwards.

About Parkinson's Disease

Parkinson's disease affects approximately one percent of people over age 60, causing tremor, muscle rigidity, slowed motion, shuffling gait and a loss of facial expression. All of these effects vary from patient to patient, but worsen over time. Approximately 15 percent of patients develop Parkinson's disease before the age of 50. Parkinson's disease is the second most common chronic neurological disorder in older adults after Alzheimer's.

About pramipexole

pramipexole, a compound from Boehringer Ingelheim research, is approved for the treatment of the signs and symptoms of idiopathic Parkinson's disease. Idiopathic Parkinson's disease is the most common form of parkinsonism, a group of movement disorders that have similar features and symptoms. Parkinson's disease is called idiopathic Parkinson's because the cause is unknown. In other forms of parkinsonism, a cause is known or suspected.

pramipexole is supported by nearly a decade of real-world experience in the treatment of Parkinson's disease, and approximately 9.1 million prescriptions for pramipexole have been written in the U.S. since its launch in 1997.

pramipexole may cause patients to fall asleep without any warning, even while doing normal daily activities such as driving.

When taking pramipexole hallucinations may occur and sometimes patients may feel dizzy, sweaty or nauseated upon standing up. The most common side effects in clinical trials for RLS were nausea, headache, and tiredness. The most commonly reported adverse events in early and late Parkinson's disease in clinical trials were dizziness, involuntary movement, hallucinations, headache, difficulty falling asleep, sleepiness, and nausea. Patients and caregivers should be informed that impulse control disorders/compulsive behaviors may occur while taking medicines, including pramipexole, to treat Parkinson's disease.

Boehringer Ingelheim

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 143 affiliates in 47 countries and approximately 37,500 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 2005, Boehringer Ingelheim posted net sales of US $11.8 billion (9.5 billion euro) while spending approximately one-fifth of net sales in its largest business segment, Prescription Medicines, on research and development.

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Source: Boehringer Ingelheim

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