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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 August 9, 2018

FOR MORE INFORMATION
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.
Show details

- 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.
Show details

- 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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Polysomnography Study Of Pregabalin And Pramipexole Versus Placebo In Patients With Restless Legs Syndrome And Associated Sleep Disturbance
A Randomized, Double-Blind, Placebo-Controlled, 3-Way Crossover, Multicenter Polysomnography Study Of Pregabalin And Pramipexole In Adults With Restless Legs Syndrome
The purpose of this study is to assess the efficacy and safety of pregabalin and pramipexole versus placebo in the treatment of restless legs syndrome and associated sleep disturbance.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Restless Legs Syndrome
  • Drug: pregabalin
    capsules; 300 mg once-per-day; 4 weeks of treatment
    Other Name: Lyrica
  • Drug: placebo
    capsules; 0 mg once-per-day; 4 weeks of treatment
  • Drug: pramipexole
    capsules; 0.5 mg once-per-day; 4 weeks of treatment
    Other Name: Mirapex
  • Experimental: pregabalin
    Intervention: Drug: pregabalin
  • Placebo Comparator: placebo
    Intervention: Drug: placebo
  • Active Comparator: pramipexole
    Intervention: Drug: pramipexole
Garcia-Borreguero D, Patrick J, DuBrava S, Becker PM, Lankford A, Chen C, Miceli J, Knapp L, Allen RP. Pregabalin versus pramipexole: effects on sleep disturbance in restless legs syndrome. Sleep. 2014 Apr 1;37(4):635-43. doi: 10.5665/sleep.3558.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
85
June 2011
June 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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:

  • 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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00991276
A0081185
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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