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

NCT00375284 | Completed Phase 4

• 1 other identifier: 248.616
• Study Type: interventional
• Target: 404
• Locations: 1 country
• Sites: 52

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).

Conditions

Restless Legs Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Interventions

Pramipexole DRUG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Male or female out-patients 18 to 80 years of age.
• 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.
• IRLS rating scale score \>15 at baseline (Visit 2).

You may not qualify if:

• 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.
• Any women of child-bearing potential not having negative pregnancy test at screening.
• Breastfeeding women.
• 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).
• 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.
• Withdrawal symptoms of any medication must not be present at baseline (Visit 2).
• Previous pramipexole non-responders in other indications than RLS.
• Patients with known hypersensitivity to pramipexole or any other component of the investigational product or placebo tablets.
• Confirmed diagnosis of diabetes mellitus requiring insulin therapy.
• Any of the following lab results at screening:
• Patients with any clinically significant abnormalities in laboratory parameters at screening at the investigators discretion.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (52)

248.616.065 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

Location

248.616.028 Boehringer Ingelheim Investigational Site

Dothan, Alabama, United States

Location

248.616.035 Boehringer Ingelheim Investigational Site

Mesa, Arizona, United States

Location

248.616.025 Boehringer Ingelheim Investigational Site

Peoria, Arizona, United States

Location

248.616.073 Boehringer Ingelheim Investigational Site

Phoenix, Arizona, United States

Location

248.616.067 Boehringer Ingelheim Investigational Site

Tucson, Arizona, United States

Location

248.616.009 Boehringer Ingelheim Investigational Site

Fayetteville, Arkansas, United States

Location

248.616.040 Boehringer Ingelheim Investigational Site

Foothill Ranch, California, United States

Location

248.616.062 Boehringer Ingelheim Investigational Site

Fullerton, California, United States

Location

248.616.050 Boehringer Ingelheim Investigational Site

Pasadena, California, United States

Location

248.616.031 Boehringer Ingelheim Investigational Site

Colorado Springs, Colorado, United States

Location

248.616.017 Boehringer Ingelheim Investigational Site

Pueblo, Colorado, United States

Location

248.616.071 Boehringer Ingelheim Investigational Site

Wallingford, Connecticut, United States

Location

248.616.043 Boehringer Ingelheim Investigational Site

DeLand, Florida, United States

Location

248.616.014 Boehringer Ingelheim Investigational Site

Jacksonville, Florida, United States

Location

248.616.020 Boehringer Ingelheim Investigational Site

Naples, Florida, United States

Location

248.616.048 Boehringer Ingelheim Investigational Site

Pembroke Pines, Florida, United States

Location

248.616.072 Boehringer Ingelheim Investigational Site

Spring Hill, Florida, United States

Location

248.616.018 Boehringer Ingelheim Investigational Site

St. Petersburg, Florida, United States

Location

248.616.049 Boehringer Ingelheim Investigational Site

Augusta, Georgia, United States

Location

248.616.033 Boehringer Ingelheim Investigational Site

Columbus, Georgia, United States

Location

248.616.057 Boehringer Ingelheim Investigational Site

Macon, Georgia, United States

Location

248.616.066 Boehringer Ingelheim Investigational Site

Savannah, Georgia, United States

Location

248.616.047 Boehringer Ingelheim Investigational Site

Stockbridge, Georgia, United States

Location

248.616.059 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Location

248.616.045 Boehringer Ingelheim Investigational Site

Lenexa, Kansas, United States

Location

248.616.061 Boehringer Ingelheim Investigational Site

Olathe, Kansas, United States

Location

248.616.060 Boehringer Ingelheim Investigational Site

Baton Rouge, Louisiana, United States

Location

248.616.058 Boehringer Ingelheim Investigational Site

Brighton, Massachusetts, United States

Location

248.616.051 Boehringer Ingelheim Investigational Site

Wellesley Hills, Massachusetts, United States

Location

248.616.001 Boehringer Ingelheim Investigational Site

Minneapolis, Minnesota, United States

Location

248.616.004 Boehringer Ingelheim Investigational Site

Jackson, Mississippi, United States

Location

248.616.064 Boehringer Ingelheim Investigational Site

Florissant, Missouri, United States

Location

248.616.016 Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

Location

248.616.063 Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

Location

248.616.053 Boehringer Ingelheim Investigational Site

Dover, New Hampshire, United States

Location

248.616.036 Boehringer Ingelheim Investigational Site

Albuquerque, New Mexico, United States

Location

248.616.021 Boehringer Ingelheim Investigational Site

Albany, New York, United States

Location

248.616.013 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

Location

248.616.003 Boehringer Ingelheim Investigational Site

Cleveland, Ohio, United States

Location

248.616.068 Boehringer Ingelheim Investigational Site

Marion, Ohio, United States

Location

248.616.012 Boehringer Ingelheim Investigational Site

Norman, Oklahoma, United States

Location

248.616.006 Boehringer Ingelheim Investigational Site

Oklahoma City, Oklahoma, United States

Location

248.616.019 Boehringer Ingelheim Investigational Site

Oklahoma City, Oklahoma, United States

Location

248.616.069 Boehringer Ingelheim Investigational Site

Clarks Summit, Pennsylvania, United States

Location

248.616.008 Boehringer Ingelheim Investigational Site

Columbia, South Carolina, United States

Location

248.616.005 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

Location

248.616.070 Boehringer Ingelheim Investigational Site

Rockwall, Texas, United States

Location

248.616.039 Boehringer Ingelheim Investigational Site

San Marcos, Texas, United States

Location

248.616.011 Boehringer Ingelheim Investigational Site

Alexandria, Virginia, United States

Location

248.616.055 Boehringer Ingelheim Investigational Site

Norfolk, Virginia, United States

Location

248.616.024 Boehringer Ingelheim Investigational Site

Milwaukee, Wisconsin, United States

Location

MeSH Terms

Conditions

Restless Legs Syndrome

Interventions

Pramipexole

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzothiazoles; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 11, 2006
• First Posted: September 12, 2006
• Study Start: September 1, 2006
• Primary Completion: July 1, 2007
• Last Updated: October 31, 2013

Record last verified: 2013-10

Locations

US (52)