NCT00152997|CompletedPhase 2

Pramipexole (BI-Sifrol®) Orally Once Daily for 6 Weeks in Patients With Primary Restless Legs Syndrome

A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Pramipexole With the Dose Range From 0.125 mg to 0.75 mg Orally Once Daily for 6 Weeks in Patients With Primary Restless Legs Syndrome.

Boehringer Ingelheim ClinicalTrials.gov

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1 other identifier

248.557

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredSep 2005

StartedAug 2004

Brief Summary

The objective of this trial is to investigate the efficacy and safety of pramipexole (0.125-0.75 mg) orally once daily as compared with placebo for 6 weeks in patients with primary restless legs syndrome (RLS) and to investigate the reliability of the Japanese version of the RLS rating scale by the International Restless Legs Syndrome Study Group (IRLSSG) as a sub-study.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_2

Geographic Reach

1 country

7 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed

1.1 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed

3 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed

3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed

Last Updated

October 31, 2013

Status Verified

October 1, 2013

Enrollment Period

1.3 years

First QC Date

September 9, 2005

Last Update Submit

October 30, 2013

Conditions

Restless Legs Syndrome

Outcome Measures

Primary Outcomes (1)

Primary Endpoint: Decrease in periodic limb movements during time in bed index (PLMI) in the PSG

Secondary Outcomes (1)

Total score of RLS severity scale-J by IRLSSG, Periodic Limb Movements during Sleep Index (PLMSI) in the PSG Periodic Limb Movements during Wakefulness Index (PLMWI) in the PSG Periodic Limb Movements in Sleep with Arousal Index (PLMAI) in the PSG )

Interventions

Pramipexole 0.125 mg tabletsDRUG

Pramipexole 0.125 mg tablets PlaceboDRUG

Eligibility Criteria

Age20 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

According to the essential diagnostic criteria for RLS of NIH and IRLSSG, the following four all criterias must be presented:
An urge to move the legs, usually accompanied or caused by uncomfortable and unpleasant sensations in 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
PLM (during time in bed) index of at least 5 per hour (in the worst affected leg) at Visit 3
Total score of RLS severity scale-Japanese version by IRLSSG \> 15 at Visit 3
At least 1 time per week of RLS symptoms interfering with sleep within the last one month at Visit 1.

You may not qualify if:

Pre-menopausal women who meet any one of the following (1) - (3):
Pregnant or possibly pregnant
In lactation
Desire to be pregnant during study period Even when a patient was confirmed not to fall under the criteria above at initiation of study, if the patient is of childbearing potential, pregnancy tests should be performed when possible. If pregnancy test is positive, the investigational product should be discontinued.
Males not using an adequate form of contraception.
Patients who took the neuroleptics within 4 weeks before the screening Visit 1, or neuroleptic-induced akathisia.
Patients who can not stop the treatment with medication or dietary supplements, which could significantly influence RLS symptoms to wash-out at least 14 days before drug administration (refer to Appendix 3 for prohibited medication), e.g. dopaminergic drugs (levodopa or dopamine agonists) or antidopaminergic drugs (neuroleptics or metoclopramide etc.), MAO inhibitors, sympathomimetics, antidepressants, hypnotics, any benzodiazepines, antiepileptics, opioids, clonidine, magnesium, ferrous salts, folic acid, vitamin B12, antihistaminics, lithium, melatonin.
Patients with diabetes mellitus requiring insulin therapy.
Patients with microcytic anemia at investigators discretion.
History or clinical signs of peripheral neuropathy (PNP) of any origin in physical, neurological examination, myelopathy or multiple sclerosis or any other neurological disease, with potential to secondarily cause RLS symptoms.
Other sleep disorder, such as, REM sleep behaviour disorder, narcolepsy or sleep apnea syndrome (with AHI \>15 at Visit 3, or a history of loud snoring occurring at least 5 nights a week combined with a history of breathing pauses during sleep and excessive daytime sleepiness).
Clinically significant renal disease or creatinine higher than upper limit of normal (ULN) at screening.

Contact the study team to confirm eligibility.