Lyrica Dose Response Study With Restless Legs Syndrome (RLS) Patients

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NCT00676403

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Study Location
Pfizer Investigational Site
Tuscaloosa, Alabama, 35406, United States
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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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
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Moderate to severe idiopathic RLS

- symptoms occur predominantly in the evening

- symptoms interfere with sleep onset or maintenance

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Any secondary RLS


- require treatment for daytime RLS symptoms


- symptomatic neuropathies

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Advanced Information
Descriptive Information
Brief Title  ICMJE Lyrica Dose Response Study With Restless Legs Syndrome (RLS) Patients
Official Title  ICMJE Randomized, Double-Blind, 6-Week Study Of Pregabalin In Subjects With Restless Legs Syndrome
Brief Summary To test the effectiveness and tolerability of Lyrica at various dose levels in RLS patients
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Restless Legs Syndrome
Intervention  ICMJE
  • Drug: placebo
    Placebo control (capsule), once a day, 1- 3 hours before bedtime for 6 weeks
    Other Name: Sugar pill
  • Drug: Pregabalin
    50 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
    Other Name: Lyrica, PD 0144723; CI-1008
  • Drug: Pregabalin
    100 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
    Other Name: Lyrica, PD 0144723; CI-1008
  • Drug: Pregabalin
    150 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
    Other Name: Lyrica, PD 0144723; CI-1008
  • Drug: Pregabalin
    300 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
    Other Name: Lyrica, PD 0144723; CI-1008
  • Drug: Pregabalin
    450 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
    Other Name: Lyrica, PD 0144723; CI-1008
Study Arms  ICMJE
  • Placebo Comparator: 1
    Placebo
    Intervention: Drug: placebo
  • Experimental: 2
    investigational treatment
    Intervention: Drug: Pregabalin
  • Experimental: 3
    investigational treatment
    Intervention: Drug: Pregabalin
  • Experimental: 4
    investigational treatment
    Intervention: Drug: Pregabalin
  • Experimental: 5
    investigational treatment
    Intervention: Drug: Pregabalin
  • Experimental: 6
    investigational treatment
    Intervention: Drug: Pregabalin
Publications * Allen R, Chen C, Soaita A, Wohlberg C, Knapp L, Peterson BT, García-Borreguero D, Miceli J. A randomized, double-blind, 6-week, dose-ranging study of pregabalin in patients with restless legs syndrome. Sleep Med. 2010 Jun;11(6):512-9. doi: 10.1016/j.sleep.2010.03.003. Epub 2010 May 13.

*   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: January 8, 2010)		137
Original Estimated Enrollment  ICMJE
 (submitted: May 12, 2008)		120
Actual Study Completion Date  ICMJE January 2009
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Moderate to severe idiopathic RLS
  • symptoms occur predominantly in the evening
  • symptoms interfere with sleep onset or maintenance

Exclusion Criteria:

  • Any secondary RLS
  • require treatment for daytime RLS symptoms
  • symptomatic neuropathies
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (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 Austria,   Germany,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00676403
Other Study ID Numbers  ICMJE A0081183
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
Study Sponsor  ICMJE Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date June 2010

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