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Non-Interventional Observational Study on the Influence of Pramipexole on Sensory Symptoms of Restless Legs Syndrome (RLS)
This study is not yet open for participant recruitment.
Verified by Boehringer Ingelheim Pharmaceuticals, April 2009
First Received: July 29, 2008   Last Updated: April 22, 2009   History of Changes
Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00887289
  Purpose

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:

  • To investigate the influence of Sifrol® (pramipexole) treatment on unpleasant sensory symptoms of RLS as measured with the short form of the McGill Pain Questionnaire.
  • To assess if improvement of sensory symptoms correlates with overall RLS severity (IRLS) and with secondary symptoms like sleeping problems and daytime tiredness (items 1 & 6 from RLS-6).
  • To evaluate if the treatment effect of Sifrol on overall RLS severity (IRLS) differs between patients with high pain scores and patients with lower pain scores.
  • To compare GP and neurologist sites patient populations in terms of demographics, RLS severity at Visit 1 and treatment outcomes at Visit 3.
  • To evaluate the development of behavioural changes under PPX treatment.

Condition
Restless Legs Syndrome

MedlinePlus related topics: Restless Legs
Drug Information available for: Pramipexol Pramipexole dihydrochloride
U.S. FDA Resources
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)

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • To investigate the influence fo Sifrol (pramipexole) treatment on unpleasant sensory symptoms of RLS [ Time Frame: 11 to 14 weeks ]

Secondary Outcome Measures:
  • To evaluate the development of behavioural changes under pramipexole treatment [ Time Frame: 11 to 14 weeks ]

Estimated Enrollment: 2680
Study Start Date: April 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Detailed Description:

Study Design:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Study Population

RLS patients

Criteria

Inclusion Criteria:

  1. Diagnosis of primary moderate to severe RLS.
  2. Patients who are planned to be treated with Sifrol® (pramipexole) and where the decision of treatment is made independent of the patients' inclusion into this PMS study.
  3. Male or female patients aged at least 18 years.
  4. Written informed consent by the patient for study participation.

Exclusion Criteria:

  1. Any contraindications according to the Summary of Product Characteristics (SPC): hypersensitivity to pramipexole or to any of the excipients.
  2. Previous or ongoing treatment with Sifrol® (pramipexole).
  3. Previous or ongoing treatment with dopamine receptor agonists.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00887289

Contacts
Contact: Boehringer Ingelheim Study Coordinator 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

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

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 06, 2009