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

NCT00991276

Last updated date
Study Location
Pfizer Investigational Site
Jasper, Alabama, 35501, United States
Contact
1-800-718-1021

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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.

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NCT00991276
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Advanced Information
Descriptive Information
Brief Title  ICMJE Polysomnography Study Of Pregabalin And Pramipexole Versus Placebo In Patients With Restless Legs Syndrome And Associated Sleep Disturbance
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled, 3-Way Crossover, Multicenter Polysomnography Study Of Pregabalin And Pramipexole In Adults With Restless Legs Syndrome
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Restless Legs Syndrome
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: pregabalin
    Intervention: Drug: pregabalin
  • Placebo Comparator: placebo
    Intervention: Drug: placebo
  • Active Comparator: pramipexole
    Intervention: Drug: pramipexole
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 20, 2011)
85
Original Estimated Enrollment  ICMJE
 (submitted: October 6, 2009)
105
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00991276
Other Study ID Numbers  ICMJE A0081185
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP