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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00375284
Other study ID # 248.616
Secondary ID
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. completion date
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


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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