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Non-interventional Observational Study on the Influence of Pramipexole on Sensory Symptoms of Restless Legs Syndrome (RLS)

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ClinicalTrials.gov Identifier: NCT00887289
Recruitment Status : Completed
First Posted : April 23, 2009
Results First Posted : December 15, 2010
Last Update Posted : June 27, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:

The main goal of this open-label, prospective, non-controlled, non-interventional post marketing surveillance study is to evaluate how pramipexole treatment works when applied in actual practice. In actual practice patients who would have been excluded in the clinical registration studies of pramipexole in moderate to severe primary Restless Legs Syndrome (i.e. those with certain disease histories, co-morbidities and/or demographic characteristics) will also be treated with pramipexole. Thus, during this post marketing surveillance study additional information on the efficacy and safety of pramipexole in those patients will be obtained. The objectives of this post marketing surveillance study are:

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

Condition or disease
Restless Legs Syndrome

Detailed Description:
Study Design:

Study Type : Observational
Actual Enrollment : 1504 participants
Time Perspective: Prospective
Official Title: Non-interventional Observational Study on the Influence of Pramipexole (PPX) on Sensory Symptoms of Restless Legs Syndrome (RLS)
Study Start Date : April 2009
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Restless Legs
U.S. FDA Resources




Primary Outcome Measures :
  1. Summary of Change From Baseline in Total Sum of McGill Pain Questionnaire to Visit 3 [ Time Frame: Baseline to Visit 3 ]
    Change in Total Sum Score of McGill Pain Questionnaire at Visit 3 to baseline. The sum scores can have values in the range from 0 (no pain) to 20 (worst pain). A negative change is an improvement of pain, a positive change a worsening of pain.

  2. Summary of Change From Baseline in Total Sum of McGill Pain Questionnaire to Visit 3 for Patients Treated by General Practitioner [ Time Frame: Baseline to Visit 3 ]
    Change in Total Sum Score of McGill Pain Questionnaire at Visit 3 to baseline. The sum scores can have values in the range from 0 (no pain) to 20 (worst pain). A negative change is an improvement of pain, a positive change a worsening of pain.

  3. Summary of Change From Baseline in Total Sum of McGill Pain Questionnaire to Visit 3 for Patients Treated by Neurologist [ Time Frame: Baseline to Visit 3 ]
    Change in Total Sum Score of McGill Pain Questionnaire at Visit 3 to baseline. The sum scores can have values in the range from 0 (no pain) to 20 (worst pain). A negative change is an improvement of pain, a positive change a worsening of pain.


Secondary Outcome Measures :
  1. Summary of Change From Baseline in Restless Legs Syndrome Severity Scale With 6 Questions to Visit 3 [ Time Frame: Baseline to Visit 3 ]
    Change in RLS-6 at Visit 3 to baseline. The sum scores can have values in the range from 0 (best) to 20 (worst) A negative change is an improvement of RLS-6, a positive change a worsening of RLS-6.

  2. Summary of Change From Baseline in International Restless Legs Syndrome Scale for Severity to Visit 3 [ Time Frame: Baseline to Visit 3 ]
    Change in IRLS at Visit 3 to baseline. The sum scores can have values in the range from 0 (best) to 40 (worst) A negative change is an improvement of IRLS, a positive change a worsening of IRLS.

  3. Behavioural Changes During Treatment [ Time Frame: Baseline to Visit 3 ]
    Number of patients with occurence of behavioural changes in terms of impulse control disorders



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
RLS patients
Criteria

Inclusion criteria:

  1. Diagnosis of primary moderate to severe Restless Legs Syndrome.
  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 post marketing surveillance 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: 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00887289


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Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00887289     History of Changes
Other Study ID Numbers: 248.659
First Posted: April 23, 2009    Key Record Dates
Results First Posted: December 15, 2010
Last Update Posted: June 27, 2014
Last Verified: March 2014

Additional relevant MeSH terms:
Syndrome
Psychomotor Agitation
Restless Legs Syndrome
Disease
Pathologic Processes
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Parasomnias
Mental Disorders
Pramipexole
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents