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

October 30, 2013 updated by: Boehringer Ingelheim

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

404

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Interventional Model: Parallel Assignment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

September 11, 2006

First Submitted That Met QC Criteria

September 11, 2006

First Posted (Estimate)

September 12, 2006

Study Record Updates

Last Update Posted (Estimate)

October 31, 2013

Last Update Submitted That Met QC Criteria

October 30, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 248.616

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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