Clinical Trials/NCT00390689

NCT00390689

Completed

Phase 3

A Randomised, Double-blind Study to Evaluate the Efficacy and Safety of Pramipexole at Fixed Doses of 0.25 mg, 0.5 mg, and 0.75 mg in Patients With Idiopathic Restless Legs Syndrome for 6 Weeks, Followed by a 46-week Open-label Long-term Study

Boehringer Ingelheim34 sites in 1 country154 target enrollmentOctober 2006

ConditionsIdiopathic Restless Legs Syndrome

InterventionsPramipexole 0.125 mg tablet Pramipexole 0.5 mg tablet

DrugsPramipexole 0.125 mg tablet Pramipexole 0.5 mg tablet

Overview

Phase: Phase 3
Intervention: Pramipexole 0.125 mg tablet
Conditions: Idiopathic Restless Legs Syndrome
Sponsor: Boehringer Ingelheim
Enrollment: 154
Locations: 34
Primary Endpoint: Change From Baseline in International Restless Legs Syndrome (IRLS) Total Score at 6 Weeks
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of double blind phase in this trial is to compare the efficacy and safety at the fixed dose of 0.25 mg,0.5 mg and 0.75 mg pramipexole in RLS. The objective of open label phase in this trial is to investigate the long term safety and efficacy of pramipexole in RLS.

Registry

clinicaltrials.gov

Start Date

October 2006

End Date

March 2008

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Boehringer Ingelheim

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female patients between 20 and 80 years
•Patients with a diagnosis of restless legs syndrome (RLS) according to the following diagnosis criteria of National institute of health (NIH)/International restless legs syndrome study group (IRLSSG):
•An urge to move the legs, usually accompanied or caused by uncomfortable and unpleasant sensations in 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.
•Patients with a total score larger than 15 on the IRLS at Visit 2

Exclusion Criteria

•Premenopausal women who meet any of the following 1) to 3) 1) Patients who are pregnant or possibly pregnant 2) Patients who are lactating 3) Patients who wish to become pregnant during the study period
•Patients who cannot take adequate contraceptive measures
•Patients with a history of akathisia induced by neuroleptics
•Patients with diabetes mellitus requiring insulin therapy
•Patients who are judged to have microcytic anaemia by the investigator or sub-investigator
•Patients with a history or signs of peripheral neuropathy, myelopathy, multiple sclerosis, Parkinson's disease or other neurological diseases that may result in the occurrence of secondary RLS in the physical function tests or neurological tests
•Patients with other sleep disorders such as abnormal behaviour during Rapid eye movement (REM) sleep, narcolepsy and sleep apnoea syndrome (patients with an apnoea-hypopnoea index (AHI) exceeding 15 determined by polysomnography at the relevant trial site or those with loud snoring at least 5 nights/week and an experience of respiratory arrest during sleep or excessive daytime sleepiness)

Arms & Interventions

Pramipexole 0.25 mg once daily

Pramipexole 0.25 mg given once daily

Intervention: Pramipexole 0.125 mg tablet

Pramipexole 0.5 mg once daily

Pramipexole 0.5 mg given once daily

Intervention: Pramipexole 0.5 mg tablet

Pramipexole 0.75 mg once daily

Pramipexole 0.75 mg given once daily

Intervention: Pramipexole 0.125 mg tablet

Pramipexole 0.75 mg once daily

Pramipexole 0.75 mg given once daily

Intervention: Pramipexole 0.5 mg tablet

Outcomes

Primary Outcomes

Change From Baseline in International Restless Legs Syndrome (IRLS) Total Score at 6 Weeks

Time Frame: Week 6 - change from baseline

The International Restless Legs Syndrome Study Group (IRLSSG) proposes classification of severity based on the total score on the IRLS (0-10, mild; 11-20, moderate; 21-30, severe; 31-40, very severe). A decrease in the score of the IRLS by 10 or more points corresponds to the improvement of severity by one rank and has clinical importance. Therefore, the primary endpoint in the double-blind period was set as a decrease by 10 or more points in the mean change on the total score of the IRLS from the baseline to Visit 5 (last observation day in the double-blind period) at all doses of 0.25 mg, 0.5 mg, and 0.75 mg/day of pramipexole.

Secondary Outcomes

IRLS Responder(baseline to week 6)
Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Score at 6 Weeks(Week 6 - change from baseline)
Clinically Significant Abnormalities in Vital Signs (Blood Pressure and Pulse Rate in Both Supine and Standing Positions), ECG, Laboratory Tests - Double Blind Period.(baseline to 6 weeks)
Change From Baseline in Japanese Version of the Epworth Sleepiness Scale (JESS) Total Score at 6 Weeks(Week 6 - change from baseline)
Clinical Global Impression Global Improvement (CGI-I) Responder(baseline to week 6)
Patient Global Impression (PGI) Responder(baseline to week 6)
Change From Baseline in International Restless Legs Syndrome (IRLS) Total Score at 52 Weeks for Open-Label Period(Week 52 - change from baseline)
IRLS Responder for Open-label Period(baseline to week 52)
Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Score at 52 Weeks for Open-Label Period(Week 52 - change from baseline)
Change From Baseline in Japanese Version of the Epworth Sleepiness Scale (JESS) Total Score at 52 Weeks for Open-Label Period(Week 52 - change from baseline)
Patient Global Impression (PGI) Responder at 52 Weeks for Open-Label Period(baseline to week 52)
Clinical Global Impression Global Improvement (CGI-I) Responder at 52 Weeks for Open-label Period(baseline to week 52)
Possible Augmentation in RLS Symptoms at 52 Weeks for Open-Label Period(baseline to week 52)