A 6 Week Trial to Study the Efficacy and Safety of a Starting Dose 0.25 mg Pramipexole (Mirapex) in Patients With RLS
- Conditions
- Restless Legs Syndrome
- Registration Number
- NCT00375284
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
This trial is a 6-week, double-blind, randomized, active and placebo-controlled parallel-group study with a primary objective of comparison of starting doses of pramipexole fixed-dose (0.25 mg daily) and pramipexole titrated-dose (0.125 mg qd for 1 week, then 0.25 mg qd for the remaining 5 weeks) with placebo to evaluate efficacy and safety in treating RLS symptoms in patients diagnosed with idiopathic RLS.
The secondary objectives of this study will be to assess the onset of action of symptomatic relief of RLS for pramipexole with daily assessment of PGI and modified IRLS during two intervals of the first 2 weeks (Days 2, 3 and 4 and Days 9, 10, and 11) and assessment of IRLS, PGI and CGI-I at Weeks 1, 2, 4 and 6 (CGI-I additionally on Day 3).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 404
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Written informed consent consistent with ICH-GCP and local IRB/IEC requirements obtained prior to any study procedures being performed and the ability and willingness to comply with study treatment regimen and to attend study assessments.
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Male or female out-patients 18 to 80 years of age.
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Diagnosis of idiopathic RLS according to the clinical RLS criteria revised by the IRLSSG in collaboration with the U.S.A. National Institutes of Health [P03-03355]. All four criteria must be present to fulfil the diagnosis of RLS:
- An urge to move the legs, usually accompanied or caused by uncomfortable and unpleasant sensations in the legs. (Sometimes the urge to move is present without the uncomfortable sensations and sometimes the arms or other body parts are involved in addition to the legs).
The urge to move or unpleasant sensations begin or worsen during periods of rest or inactivity such as lying or sitting.
- The urge to move or unpleasant sensations are partially or totally relieved by movement, such as walking or stretching, at least as long as the activity continues.
- The urge to move or unpleasant sensations are worse in the evening or night than during the day or only occur in the evening or night. (When symptoms are very severe, the worsening at night may not be noticeable but must have been previously present).
-
RLS symptoms present at least 2 to 3 days per week during the last 3 months.
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IRLS rating scale score >15 at baseline (Visit 2).
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Women of child-bearing potential (i.e., premenopausal women, or postmenopausal women less than 6 months after last menses) who do not use during the clinical trial an adequate method of contraception such as: double barrier protection (e.g., diaphragm or condom and spermicide), intrauterine device, hormonal therapy (oral, injectable, or subcutaneous), or partners surgical sterilization.
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Any women of child-bearing potential not having negative pregnancy test at screening.
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Breastfeeding women.
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Concomitant or previous pharmacologic therapy for RLS as follows:
- Any intake of dopamine agonists within 14 days prior to baseline (Visit 2).
- Any intake of L-dopa within 14 days prior to baseline (Visit 2).
- Any intake of L-dopa prior to baseline visit, if augmentation in RLS symptoms was observed.
- Unsuccessful prior treatment with non-ergot dopamine agonists (e.g., pramipexole, ropinirole).
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All treatment less than 14 days before baseline (Visit 2) or concomitant treatment with medication or dietary supplements which could significantly influence RLS symptoms, e.g., dopaminergic (other than levodopa and dopamine agonists) or antidopaminergic drugs, non-selective MAO inhibitors, sympathomimetics, neuroleptics, antidepressants, hypnotics, any benzodiazepines, antiepileptics, opioids, clonidine, ferrous salts, magnesium, folic acid, vitamin B12, antihistaminics, lithium, metoclopramide.
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Withdrawal symptoms of any medication must not be present at baseline (Visit 2).
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Previous pramipexole non-responders in other indications than RLS.
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Patients with known hypersensitivity to pramipexole or any other component of the investigational product or placebo tablets.
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Confirmed diagnosis of diabetes mellitus requiring insulin therapy.
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Any of the following lab results at screening:
- Patients with any clinically significant abnormalities in laboratory parameters at screening at the investigators discretion.
- Haemoglobin (Hb) below lower limit of normal (LLN).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The co-primary endpoints are: Assessment of clinical response of treatment measured by the change from baseline in total IRLS score and CGI-I responder rate (at least much improved) after 6 weeks, 2 weeks and 1 week. 6 weeks
- Secondary Outcome Measures
Name Time Method Onset of action on Day 3 as measured by the CGI-I responder rate Onset of action as measured by PGI and modified IRLS score Clinical Global Impression of improvement Patient Global Impression IRLS as a responder rate VAS score for pain in limbs 6 weeks
Trial Locations
- Locations (52)
248.616.035 Boehringer Ingelheim Investigational Site
🇺🇸Mesa, Arizona, United States
248.616.049 Boehringer Ingelheim Investigational Site
🇺🇸Augusta, Georgia, United States
248.616.066 Boehringer Ingelheim Investigational Site
🇺🇸Savannah, Georgia, United States
248.616.060 Boehringer Ingelheim Investigational Site
🇺🇸Baton Rouge, Louisiana, United States
248.616.004 Boehringer Ingelheim Investigational Site
🇺🇸Jackson, Mississippi, United States
248.616.003 Boehringer Ingelheim Investigational Site
🇺🇸Cleveland, Ohio, United States
248.616.059 Boehringer Ingelheim Investigational Site
🇺🇸Chicago, Illinois, United States
248.616.045 Boehringer Ingelheim Investigational Site
🇺🇸Lenexa, Kansas, United States
248.616.061 Boehringer Ingelheim Investigational Site
🇺🇸Olathe, Kansas, United States
248.616.065 Boehringer Ingelheim Investigational Site
🇺🇸Birmingham, Alabama, United States
248.616.001 Boehringer Ingelheim Investigational Site
🇺🇸Minneapolis, Minnesota, United States
248.616.073 Boehringer Ingelheim Investigational Site
🇺🇸Phoenix, Arizona, United States
248.616.019 Boehringer Ingelheim Investigational Site
🇺🇸Oklahoma City, Oklahoma, United States
248.616.013 Boehringer Ingelheim Investigational Site
🇺🇸Cincinnati, Ohio, United States
248.616.024 Boehringer Ingelheim Investigational Site
🇺🇸Milwaukee, Wisconsin, United States
248.616.014 Boehringer Ingelheim Investigational Site
🇺🇸Jacksonville, Florida, United States
248.616.020 Boehringer Ingelheim Investigational Site
🇺🇸Naples, Florida, United States
248.616.072 Boehringer Ingelheim Investigational Site
🇺🇸Spring Hill, Florida, United States
248.616.028 Boehringer Ingelheim Investigational Site
🇺🇸Dothan, Alabama, United States
248.616.025 Boehringer Ingelheim Investigational Site
🇺🇸Peoria, Arizona, United States
248.616.062 Boehringer Ingelheim Investigational Site
🇺🇸Fullerton, California, United States
248.616.050 Boehringer Ingelheim Investigational Site
🇺🇸Pasadena, California, United States
248.616.071 Boehringer Ingelheim Investigational Site
🇺🇸Wallingford, Connecticut, United States
248.616.033 Boehringer Ingelheim Investigational Site
🇺🇸Columbus, Georgia, United States
248.616.018 Boehringer Ingelheim Investigational Site
🇺🇸St. Petersburg, Florida, United States
248.616.058 Boehringer Ingelheim Investigational Site
🇺🇸Brighton, Massachusetts, United States
248.616.051 Boehringer Ingelheim Investigational Site
🇺🇸Wellesley Hills, Massachusetts, United States
248.616.063 Boehringer Ingelheim Investigational Site
🇺🇸St. Louis, Missouri, United States
248.616.068 Boehringer Ingelheim Investigational Site
🇺🇸Marion, Ohio, United States
248.616.053 Boehringer Ingelheim Investigational Site
🇺🇸Dover, New Hampshire, United States
248.616.008 Boehringer Ingelheim Investigational Site
🇺🇸Columbia, South Carolina, United States
248.616.069 Boehringer Ingelheim Investigational Site
🇺🇸Clarks Summit, Pennsylvania, United States
248.616.006 Boehringer Ingelheim Investigational Site
🇺🇸Oklahoma City, Oklahoma, United States
248.616.070 Boehringer Ingelheim Investigational Site
🇺🇸Rockwall, Texas, United States
248.616.043 Boehringer Ingelheim Investigational Site
🇺🇸Deland, Florida, United States
248.616.009 Boehringer Ingelheim Investigational Site
🇺🇸Fayetteville, Arkansas, United States
248.616.016 Boehringer Ingelheim Investigational Site
🇺🇸St. Louis, Missouri, United States
248.616.040 Boehringer Ingelheim Investigational Site
🇺🇸Foothill Ranch, California, United States
248.616.064 Boehringer Ingelheim Investigational Site
🇺🇸Florissant, Missouri, United States
248.616.031 Boehringer Ingelheim Investigational Site
🇺🇸Colorado Springs, Colorado, United States
248.616.067 Boehringer Ingelheim Investigational Site
🇺🇸Tucson, Arizona, United States
248.616.017 Boehringer Ingelheim Investigational Site
🇺🇸Pueblo, Colorado, United States
248.616.048 Boehringer Ingelheim Investigational Site
🇺🇸Pembroke Pines, Florida, United States
248.616.057 Boehringer Ingelheim Investigational Site
🇺🇸Macon, Georgia, United States
248.616.005 Boehringer Ingelheim Investigational Site
🇺🇸Dallas, Texas, United States
248.616.047 Boehringer Ingelheim Investigational Site
🇺🇸Stockbridge, Georgia, United States
248.616.021 Boehringer Ingelheim Investigational Site
🇺🇸Albany, New York, United States
248.616.055 Boehringer Ingelheim Investigational Site
🇺🇸Norfolk, Virginia, United States
248.616.012 Boehringer Ingelheim Investigational Site
🇺🇸Norman, Oklahoma, United States
248.616.039 Boehringer Ingelheim Investigational Site
🇺🇸San Marcos, Texas, United States
248.616.011 Boehringer Ingelheim Investigational Site
🇺🇸Alexandria, Virginia, United States
248.616.036 Boehringer Ingelheim Investigational Site
🇺🇸Albuquerque, New Mexico, United States