Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
---|---|
Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00887289 |
The main goal of this open-label, prospective, non-controlled, non-interventional post marketing surveillance (PMS) study is to evaluate how pramipexole (PPX) treatment works when applied in actual practice. In actual practice patients who would have been excluded in the clinical registration studies of PPX in moderate to severe primary RLS (i.e. those with certain disease histories, co-morbidities and/or demographic characteristics) will also be treated with PPX. Thus, during this PMS study additional information on the efficacy and safety of PPX in those patients will be obtained. The objectives of this
PMS study are:
Condition |
---|
Restless Legs Syndrome |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | Non-Interventional Observational Study on the Influence of Pramipexole (PPX) on Sensory Symptoms of Restless Legs Syndrome (RLS) |
Estimated Enrollment: | 2680 |
Study Start Date: | April 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Study Design:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
RLS patients
Inclusion Criteria:
Exclusion Criteria:
Contact: Boehringer Ingelheim Study Coordinator | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
Study ID Numbers: | 248.659 |
Study First Received: | July 29, 2008 |
Last Updated: | April 22, 2009 |
ClinicalTrials.gov Identifier: | NCT00887289 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Neurotransmitter Agents Antioxidants Sleep Disorders Dyssomnias Psychomotor Agitation Dopamine Agonists Dyskinesias Pramipexol |
Sleep Disorders, Intrinsic Signs and Symptoms Dopamine Mental Disorders Restless Legs Syndrome Neurologic Manifestations Dopamine Agents Neurobehavioral Manifestations |
Neurotransmitter Agents Antioxidants Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Sleep Disorders Antiparkinson Agents Psychomotor Agitation Dopamine Agonists Pramipexol Sleep Disorders, Intrinsic Signs and Symptoms Pathologic Processes Mental Disorders Therapeutic Uses |
Syndrome Restless Legs Syndrome Psychomotor Disorders Neurobehavioral Manifestations Disease Parasomnias Nervous System Diseases Dyssomnias Dyskinesias Protective Agents Pharmacologic Actions Neurologic Manifestations Dopamine Agents Central Nervous System Agents |