An open-label clinical study to investigate pharmacokinetics (PK) of different doses (0.125 mg, 0.25 mg, 0.5 mg) of pramipexole administered once daily orally in pediatric patients who are individually optimized to stable pramipexole doses for the treatment of idiopathic Restless Legs Syndrome (RLS)

Boehringer Ingelheim Pharmaceuticals, Inc.0 sites36 target enrollmentNovember 4, 2011

ConditionsRestless Legs Syndrome MedDRA version: 14.0Level: PTClassification code 10058920Term: Restless legs syndromeSystem Organ Class: 10029205 - Nervous system disorders Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

DrugsMirapexin

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Restless Legs Syndrome
Sponsor: Boehringer Ingelheim Pharmaceuticals, Inc.
Enrollment: 36
Status: Active, not recruiting
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 4, 2011

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Boehringer Ingelheim Pharmaceuticals, Inc.

Eligibility Criteria

Inclusion Criteria

•1\) Male or female patients ages 6 years to 16 years (two age groups, 6 to 11 years and 12 to 16 years, with the same number of patients if possible)
•2\) Diagnosis of idiopathic RLS according to the Clinical RLS criteria of the IRLSSG. All 4 of the following criteria had to be present:
•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.)
•3\) Must have met all 4 of the diagnostic criteria for adult RLS (see inclusion criterion No. 2 above) and either:
•(a) The child had to be able to describe the leg discomfort in their own words or
•(b) The child must have had 2 or 3 of the following:
•Sleep disturbance

Exclusion Criteria

•1\) Any women of childbearing potential having a positive serum pregnancy test at screening
•2\) Any women of childbearing potential not using a medically accepted method of contraceptive (Intra\-Uterine Device, oral, implantable, injectable contraceptives and estrogen patch, double barrier method \[spermacide \+ diaphragm], or abstinence at the discretion of the investigator)
•3\) Patients who have a clinically significant renal disease or serum creatinine level greater than 1\.0 mg/dL at screening
•4\) Any of the following lab results at screening:
•Hemoglobin (Hgb) below the lower limit of normal (LLN), which was determined to be clinically significant
•Basal thyroid stimulating hormone (TSH), triiodothyronine (T3\) or thyroxine (T4\) clinically significantly (at the investigator’s discretion) out of the normal range at screening (if not caused by substitution therapy according to the investigator’s opinion)
•Patients with any clinically significant abnormalities in laboratory parameters atscreening at the investigator’s discretion
•5\) Other clinically significant metabolic\-endocrine, hematological, gastrointestinal disease, pulmonary disease (such as severe asthma) which in the opinion of the investigator would preclude the patient from participating in this study
•6\) History or clinical signs of any neurological disease with potential to secondarily cause RLS symptoms
•7\) Presence of any other sleep disorder such as Rapid Eye Movement (REM) sleep behavior disorder, narcolepsy, or sleep apnea syndrome