A 12 week clinical trial was conducted in the United States in order to compare pramipexole (Mirapex®) vs. placebo for the ability to reduce the symptoms of restless legs syndrome in adult subjects.

Condition	Intervention	Phase
Restless Legs Syndrome	Drug: pramipexole	Phase III

Further Study Details: 

Primary Outcomes: restless legs syndrome
Expected Total Enrollment:  344

Ages Eligible for Study:  18 Years   -   80 Years,  Genders Eligible for Study:  Both

Criteria

INCLUSION CRITERIA

1. Male or female patients aged 18-80.

2. Diagnosis of idiopathic RLS according to the Clinical RLS criteria of the IRLSSG [P03-03355]. All four criteria must be present:

    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).

3. RLSRS score >15 measured at baseline (Visit 2).
4. RLS symptoms present at least 2 to 3 days per week during the last 3 months.
5. Written informed consent consistent with ICH/GCP and local Institutional Review Board requirements obtained prior to any study procedures being performed.
6. Ability and willingness to comply with study treatment regimen and to attend study assessments.

EXCLUSION CRITERIA

1. Women of childbearing potential, who do not use adequate protection such as barrier protection, intrauterine device, or hormonal (oral or subcutaneous) contraception during their participation of the study and 2 months after the end of the study.
2. Any women of childbearing potential not having negative serum pregnancy test at screening.
3. Breastfeeding women.

4. Concomitant or previous pharmacologic therapy for RLS as follows:

    Any intake of L-Dopa within 7 days prior to baseline visit (Visit 2).  Any intake of L-Dopa within 14 days prior to baseline visit, if augmentation was observed and related to previous L-Dopa therapy.

    Any intake of dopamine agonists within 14 days prior to baseline visit (Visit 2).

    Unsuccessful prior treatment for RLS with pramipexole.

5. Current treatment (less than 14 days before treatment with trial medication) or concomitant treatment with medication or dietary supplements, which could significantly influence RLS symptoms, e.g. , dopaminergic drugs, non-selective MAO inhibitors, sympathomimetics, neuroleptics, antidepressants, hypnotics, any benzodiazepines, antiepileptics, opioids, clonidine, magnesium, ferrous salts, vitamin B12, antihistaminics, lithium, metoclopramide; current treatment [less than 5 weeks (35 days) before treatment with trial medication] with fluoxetine hydrochloride. Withdrawal symptoms of any medication must not be present at baseline.
6. Confirmed diagnosis of diabetes mellitus requiring insulin therapy.
7. Clinically significant renal disease or creatinine clearance lower than 50 mL/minute (Cockcroft formula) at screening [R96-0690].
8. Clinically significant hepatic disease or SGOT >80 IU/L, SGPT >80 IU/L, bilirubin >2.0 mg/dL at screening.
9. Clinical or laboratory signs of microcytic anemia at the investigator’s discretion; e.g., serum iron assessment; however a patient with a serum ferritin < 10 ng/mL at Visit 1 should not be enrolled in the study.

10. Any of the following lab results at screening:

     Hemoglobin (Hgb) below lower limit of normal (LLN) which is determined to be clinically significant  Basal thyroid stimulating hormone (TSH) , triiodothyronine (T3) or thyroxine (T4) clinically significantly (at the investigator’s discretion) out of normal range at screening (if not caused by substitution therapy according the investigator’s opinion)  Positive urine drug screen for drugs of abuse  Patients with any clinically significant abnormalities in laboratory parameters at screening at the investigator’s discretion

11. Other clinically significant metabolic-endocrine, hematological, gastrointestinal disease, pulmonary disease (such as severe COPD) or poorly controlled cardiovascular disease in the opinion of the investigator (including hypotension, hypertension and severe coronary artery disease).
12. History or clinical signs of peripheral neuropathy (PNP) of any origin in physical, neurological examination, myelopathy or multiple sclerosis or any other neurological disease, with potential to secondarily cause RLS symptoms.
13. Presence of any other sleep disorder such as Rapid Eye Movement (REM) sleep behavior disorder, narcolepsy or sleep apnea syndrome.
14. History of schizophrenia or any psychotic disorder, history of mental disorders or any present Axis I psychiatric disorder according DSM IV requiring any medical therapy.
15. History of/or alcohol abuse or drug addiction within the last 2 years before screening.
16. Participation in an investigational drug study within one month prior to the start of this study.
17. History of/or clinical signs of epilepsy or seizures other than fever related seizures in early childhood.
18. History of/or clinical signs of any malignant neoplasm including suspicious undiagnosed skin lesion (which may be melanoma), melanoma, or a history of melanoma.
19. Patients on a shift-work-schedule or who are otherwise unable to follow a regular sleep-wake cycle enabling use of study medication at times indicated.
20. Any other conditions that in the opinion of the investigator would interfere with the evaluation of the results or constitute a health hazard for the patient.
21. Allergic to pramipexole or the inactive ingredients in its tablet formulation

Arizona
      Mayo Clinic - Scottsdale, Scottsdale,  Arizona,  85259,  United States
      Pivotal Reseach Centers, Peoria,  Arizona,  85381,  United States
California
      The Parkinson''''s and Movement Disorder Institute, Fountain Valley,  California,  92708,  United States
      Stanford Sleep Clinic, Stanford,  California,  94305-5730,  United States
      HealthQuest Clinical Trials Research, San Diego,  California,  92123,  United States
Colorado
      University of Colorado Health Sciences Center, Denver,  Colorado,  80262,  United States
      CNI Movement Disorders Center, Englewood,  Colorado,  80113,  United States
      National Jewish Medical and Research Center, Denver,  Colorado,  80206,  United States
District of Columbia
      George Washington University Medical Faculty Associates, Washington,  District of Columbia,  20037,  United States
Florida
      Broward Research Group, Pembroke Pines,  Florida,  33026-1956,  United States
      Clinical Research Group of St Petersburg, St. Petersburg,  Florida,  33707,  United States
      Cleveland Clinic Florida- Department of Neurology, Weston,  Florida,  33331,  United States
      PAB Clinical Research, Brandon,  Florida,  33511,  United States
Georgia
      Boehringer Ingelheim Site, Atlanta,  Georgia,  30342,  United States
      Atlanta Pulmonary Group, LLC, Atlanta,  Georgia,  30342,  United States
      Sleepmed, Inc, Macon,  Georgia,  31201,  United States
      Movement Disorders Clinic, Augusta,  Georgia,  30912,  United States
Illinois
      Northwestern University Medical School, Chicago,  Illinois,  60611,  United States
Iowa
      University of Iowa Health Care, Iowa City,  Iowa,  52242-1053,  United States
Kansas
      Mid America NeuroScience Institute, Lenexa,  Kansas,  66214,  United States
Louisiana
      Gulf Coast Research Associates, Inc., Baton Rouge,  Louisiana,  70808,  United States
Maryland
      170 Thomas Johnson Dr, Suite 100, Frederick,  Maryland,  21702,  United States
      Center for Sleep and Wake Disorders, Chevy Chase,  Maryland,  20815,  United States
Massachusetts
      Sleep Health Centers, Newton Center,  Massachusetts,  02459,  United States
Michigan
      Henry Ford Hospital - Sleep Disorders and Research Center, Detroit,  Michigan,  48202,  United States
Minnesota
      Hennepin County Medical Center, Minneapolis,  Minnesota,  55415,  United States
Mississippi
      Sleep Disorders Center, Jackson,  Mississippi,  39216,  United States
Missouri
      Sleep Medicine Center, St. Louis,  Missouri,  63108,  United States
New Mexico
      Lovelace Scientific Resources, Albuquerque,  New Mexico,  87108,  United States
New York
      Winthrop Sleep Disorders Center, Mineola,  New York,  11501,  United States
North Carolina
      Duke Health Center at Morreene Road, Durham,  North Carolina,  27705,  United States
      Wilmington Health Associates, Wilmington,  North Carolina,  28401,  United States
      Raleigh Neurology Associates, Raleigh,  North Carolina,  27607,  United States
Ohio
      Ohio Sleep Medicine Institute, Dublin,  Ohio,  43017,  United States
      Community Research, Cincinnati,  Ohio,  45219,  United States
      Metrohealth Medical Center, Cleveland,  Ohio,  44109,  United States
Oklahoma
      University of Oklahoma Health Sciences Center, Oklahoma City,  Oklahoma,  73104,  United States
Pennsylvania
      The Arthritis Group, Philadelphia,  Pennsylvania,  19152,  United States
      Center For Sleep Medicine, Lafayette Hill,  Pennsylvania,  19444,  United States
South Carolina
      SleepMed, Inc., Columbia,  South Carolina,  29201,  United States
Texas
      Sleep Associates, Plano,  Texas,  75093,  United States
      Baylor College of Medicine, Houston,  Texas,  77030,  United States
Virginia
      Eastern Virginia Medical School, Norfolk,  Virginia,  23507,  United States
      Lynchburg Pulmonary Associates, Inc., Lynchburg,  Virginia,  24501,  United States
      1500 N. Bearegard St, #300, Alexandria,  Virginia,  22311,  United States

Study chairs or principal investigators

James Cappola, Dr.,  Study Chair,  Boehringer Ingelheim Pharmaceuticals   

Study ID Numbers:  248.543
Last Updated:  August 22, 2005
Record first received:  August 22, 2005
ClinicalTrials.gov Identifier:  NCT00133198
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-23