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

Restless Legs Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00375284
• Other study ID #: 248.616
• Status: Completed
• Phase: Phase 4
• First received: September 11, 2006
• Last updated: October 30, 2013
• Start date: September 2006

Study information

• Verified date: October 2013
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 404
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psychomotor Agitation
• Restless Legs Syndrome

Intervention

Drug:
• Pramipexole

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

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