A 6 Week Trial to Study the Efficacy and Safety of a Starting Dose 0.25 mg Pramipexole (Mirapex) in Patients With RLS

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00375284
First received: September 11, 2006
Last updated: October 30, 2013
Last verified: October 2013
  Purpose

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).


Condition Intervention Phase
Restless Legs Syndrome
Drug: Pramipexole
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: A Phase IV Randomised, Double-blind, Active and Placebo-controlled, 6-week Trial to Investigate the Efficacy and Safety of a Starting (and Fixed) Dose 0.25 mg Pramipexole (Mirapex®) in Patients With Idiopathic Restless Legs Syndrome

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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. [ Time Frame: 6 weeks ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 6 weeks ]

Enrollment: 404
Study Start Date: September 2006
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Male or female out-patients 18 to 80 years of age.
  3. 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).
  4. RLS symptoms present at least 2 to 3 days per week during the last 3 months.
  5. IRLS rating scale score >15 at baseline (Visit 2).

Exclusion Criteria:

  1. 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.
  2. Any women of child-bearing potential not having negative pregnancy test at screening.
  3. Breastfeeding women.
  4. 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).
  5. 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.
  6. Withdrawal symptoms of any medication must not be present at baseline (Visit 2).
  7. Previous pramipexole non-responders in other indications than RLS.
  8. Patients with known hypersensitivity to pramipexole or any other component of the investigational product or placebo tablets.
  9. Confirmed diagnosis of diabetes mellitus requiring insulin therapy.
  10. 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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00375284

  Hide Study Locations
Locations
United States, Alabama
248.616.065 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
248.616.028 Boehringer Ingelheim Investigational Site
Dothan, Alabama, United States
United States, Arizona
248.616.035 Boehringer Ingelheim Investigational Site
Mesa, Arizona, United States
248.616.025 Boehringer Ingelheim Investigational Site
Peoria, Arizona, United States
248.616.073 Boehringer Ingelheim Investigational Site
Phoenix, Arizona, United States
248.616.067 Boehringer Ingelheim Investigational Site
Tucson, Arizona, United States
United States, Arkansas
248.616.009 Boehringer Ingelheim Investigational Site
Fayetteville, Arkansas, United States
United States, California
248.616.040 Boehringer Ingelheim Investigational Site
Foothill Ranch, California, United States
248.616.062 Boehringer Ingelheim Investigational Site
Fullerton, California, United States
248.616.050 Boehringer Ingelheim Investigational Site
Pasadena, California, United States
United States, Colorado
248.616.031 Boehringer Ingelheim Investigational Site
Colorado Springs, Colorado, United States
248.616.017 Boehringer Ingelheim Investigational Site
Pueblo, Colorado, United States
United States, Connecticut
248.616.071 Boehringer Ingelheim Investigational Site
Wallingford, Connecticut, United States
United States, Florida
248.616.043 Boehringer Ingelheim Investigational Site
Deland, Florida, United States
248.616.014 Boehringer Ingelheim Investigational Site
Jacksonville, Florida, United States
248.616.020 Boehringer Ingelheim Investigational Site
Naples, Florida, United States
248.616.048 Boehringer Ingelheim Investigational Site
Pembroke Pines, Florida, United States
248.616.072 Boehringer Ingelheim Investigational Site
Spring Hill, Florida, United States
248.616.018 Boehringer Ingelheim Investigational Site
St. Petersburg, Florida, United States
United States, Georgia
248.616.049 Boehringer Ingelheim Investigational Site
Augusta, Georgia, United States
248.616.033 Boehringer Ingelheim Investigational Site
Columbus, Georgia, United States
248.616.057 Boehringer Ingelheim Investigational Site
Macon, Georgia, United States
248.616.066 Boehringer Ingelheim Investigational Site
Savannah, Georgia, United States
248.616.047 Boehringer Ingelheim Investigational Site
Stockbridge, Georgia, United States
United States, Illinois
248.616.059 Boehringer Ingelheim Investigational Site
Chicago, Illinois, United States
United States, Kansas
248.616.045 Boehringer Ingelheim Investigational Site
Lenexa, Kansas, United States
248.616.061 Boehringer Ingelheim Investigational Site
Olathe, Kansas, United States
United States, Louisiana
248.616.060 Boehringer Ingelheim Investigational Site
Baton Rouge, Louisiana, United States
United States, Massachusetts
248.616.058 Boehringer Ingelheim Investigational Site
Brighton, Massachusetts, United States
248.616.051 Boehringer Ingelheim Investigational Site
Wellesley Hills, Massachusetts, United States
United States, Minnesota
248.616.001 Boehringer Ingelheim Investigational Site
Minneapolis, Minnesota, United States
United States, Mississippi
248.616.004 Boehringer Ingelheim Investigational Site
Jackson, Mississippi, United States
United States, Missouri
248.616.064 Boehringer Ingelheim Investigational Site
Florissant, Missouri, United States
248.616.063 Boehringer Ingelheim Investigational Site
St. Louis, Missouri, United States
248.616.016 Boehringer Ingelheim Investigational Site
St. Louis, Missouri, United States
United States, New Hampshire
248.616.053 Boehringer Ingelheim Investigational Site
Dover, New Hampshire, United States
United States, New Mexico
248.616.036 Boehringer Ingelheim Investigational Site
Albuquerque, New Mexico, United States
United States, New York
248.616.021 Boehringer Ingelheim Investigational Site
Albany, New York, United States
United States, Ohio
248.616.013 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio, United States
248.616.003 Boehringer Ingelheim Investigational Site
Cleveland, Ohio, United States
248.616.068 Boehringer Ingelheim Investigational Site
Marion, Ohio, United States
United States, Oklahoma
248.616.012 Boehringer Ingelheim Investigational Site
Norman, Oklahoma, United States
248.616.019 Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma, United States
248.616.006 Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
248.616.069 Boehringer Ingelheim Investigational Site
Clarks Summit, Pennsylvania, United States
United States, South Carolina
248.616.008 Boehringer Ingelheim Investigational Site
Columbia, South Carolina, United States
United States, Texas
248.616.005 Boehringer Ingelheim Investigational Site
Dallas, Texas, United States
248.616.070 Boehringer Ingelheim Investigational Site
Rockwall, Texas, United States
248.616.039 Boehringer Ingelheim Investigational Site
San Marcos, Texas, United States
United States, Virginia
248.616.011 Boehringer Ingelheim Investigational Site
Alexandria, Virginia, United States
248.616.055 Boehringer Ingelheim Investigational Site
Norfolk, Virginia, United States
United States, Wisconsin
248.616.024 Boehringer Ingelheim Investigational Site
Milwaukee, Wisconsin, United States
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00375284     History of Changes
Other Study ID Numbers: 248.616
Study First Received: September 11, 2006
Last Updated: October 30, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Restless Legs Syndrome
Psychomotor Agitation
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
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
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on April 16, 2014