Sifrol (Pramipexole) Onset of Action and Impact: a 12-weeks Observational Study in Patients With Primary Restless Legs Syndrome
This study has been completed.
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00721279
First received: July 23, 2008
Last updated: May 18, 2012
Last verified: May 2012
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Purpose
The objectives of the Post Market Surveillance (PMS) study are to evaluate the treatment effect of pramipexole on Restless Legs Syndrome (RLS) severity as measured by International Restless Legs Rating Scale and Global Clinical Impression - Improvement, to evaluate the time to reaching maintenance dose of pramipexole
| Condition | Intervention |
|---|---|
|
Parkinson's Disease Restless Legs Syndrome |
Drug: Pramipexole immediate release |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Sifrol Onset of Action and Impact: a 12-weeks Observational Study in Patients With Primary RLS |
Resource links provided by NLM:
Further study details as provided by Boehringer Ingelheim Pharmaceuticals:
Primary Outcome Measures:
- International Restless Legs Rating Scale [ Time Frame: Baseline and final visit (week12) ]The International Restless Legs Syndrome Rating Scale (IRLS) is a rating scale used to assess the severity of RLS symptoms. The IRLS consists of 10 items, each of which is rated from 0 to 4 points, higher values denoting an increased severity of symptoms. Maximum total score is 40. Score totals are grouped into four levels of severity: 1-10 points = mild RLS, 11-20 points = moderate RLS, 21-30 points = severe RLS, and 31-40 = very severe RLS
- Global Clinical Impression - Improvement (CGI-I) Scale [ Time Frame: baseline and final visit (week 12) ]The Clinical Global Impression Improvement scale (CGI-I) requires the clinician to rate how much the patient's illness has improved or worsened relative to a baseline state. A patient's illness is compared to change over time and rated as: very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse
| Enrollment: | 549 |
| Study Start Date: | September 2007 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients with idiopathic RLS
Criteria
Inclusion Criteria:
- Primary Restless Legs Syndrome (i.e. idiopathic RLS)
- Indication for treatment with pramipexole
- Male or female patients older than 18 years
Exclusion Criteria:
- Any contraindications according to the Summary of Product Characteristics (SPC): hypersensitivity to pramipexole or to any of the excipients
- Current treatment with pramipexole
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00721279
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| Boehringer Ingelheim Investigational Site | |
| Absam, Austria | |
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| Wr. Neustadt, Austria | |
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| Zirl, Austria | |
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
Additional Information:
No publications provided
| Responsible Party: | Boehringer Ingelheim, Study Chair, Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT00721279 History of Changes |
| Other Study ID Numbers: | 248.655 |
| Study First Received: | July 23, 2008 |
| Results First Received: | October 22, 2009 |
| Last Updated: | May 18, 2012 |
| Health Authority: | Austria: Federal Office for Safety in Health Care United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Parkinson Disease Restless Legs Syndrome Psychomotor Agitation Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Parasomnias Mental Disorders |
Dyskinesias Neurologic Manifestations Psychomotor Disorders Neurobehavioral Manifestations Signs and Symptoms Pramipexol Antioxidants Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013