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Polysomnography Study Of Pregabalin And Pramipexole Versus Placebo In Patients With Restless Legs Syndrome And Associated Sleep Disturbance

Last updated on March 14, 2019

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Study Location
Pfizer Investigational Site
Jasper, Alabama, 35501 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Restless Legs Syndrome
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Diagnosis of restless legs syndrome with a total score of 15 or more points on the
International RLS rating scale (IRLS).

- RLS symptoms interfering with sleep on 3 or more nights per week for at least 6
months.

- PSG confirmation of WASO of at least 60 min, PLMI of 10 or more, and total sleep time
of at least 3 hrs and less than 6.5 hrs.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Secondary RLS.

- Daytime RLS symptoms requiring treatment.

- Primary sleep disorder.

- Sleep apnea.

- Night or shift work.

- Concurrent medical disorder that could interfere with efficacy assessment or present a
safety concern.

- Pregnant or lactating women.

- Women of child-bearing potential not using acceptable method of birth control.

- Use of prohibited medication.

NCT00991276
Pfizer
Completed
Polysomnography Study Of Pregabalin And Pramipexole Versus Placebo In Patients With Restless Legs Syndrome And Associated Sleep Disturbance

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[email protected]

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