12-Week Efficacy And Safety Of Pregabalin In Treating Restless Legs Syndrome (RLS) Subjects

Back to Search
Print
Bookmark Trial

NCT01061372

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

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

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

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

- Idiopathic Restless Legs Syndrome with the presence of all four clinical manifestations of RLS:

- RLS symptoms occur predominantly in the evening

- RLS history at least 6 months

- International Restless Legs Study Group Rating Scale (IRLS) greater than or equal to 15 at the beginning and the end of placebo run-in

- Have greater than or equal to 15 nights with RLS symptoms in the month prior to screening

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


- Any secondary RLS


- Current augmentation due to RLS treatment


- Placebo responders identified during the placebo run-in

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

Call Now

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Advanced Search

Based on your search, you may also be interested in

Restless Legs SyndromeA Study to Determine the Efficacy and Safety of Cabergoline for the Treatment of Patients With RLS
NCT00625547
  1. Innsbruck,
  2. Wien,
  3. Altoetting,
  4. Aschaffenburg,
  5. Bad Honnef,
  6. Bad Saarow,
  7. Beckum,
  8. Berlin,
  9. Berlin,
  10. Berlin,
  11. Berlin,
  12. Berlin,
  13. Bochum,
  14. Bremerhaven,
  15. Dillingen,
  16. Duesseldorf,
  17. Duisburg,
  18. Gelsenkirchen,
  19. Gera,
  20. Goettingen,
  21. Goettingen,
  22. Halle,
  23. Hamburg,
  24. Heilbronn,
  25. Jena,
  26. Kaiserslautern,
  27. Karlsruhe,
  28. Karlsruhe,
  29. Kassel,
  30. Köthen,
  31. Marburg,
  32. Mittweida,
  33. Moenchengladbach,
  34. Neubrandenburg,
  35. Oldenburg,
  36. Quickborn,
  37. Regensburg,
  38. Schwalmstadt,
  39. Schwerin,
  40. Stuttgart,
  41. Tuttlingen,
  42. Ulm,
  43. Wiesbaden,
  44. Wolfsburg,
  45. Goteborg,
  46. Karlstad,
  47. Linköping,
  48. Basel,
  49. Bern,
  50. Zürich,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Restless Legs SyndromeLyrica Dose Response Study With Restless Legs Syndrome (RLS) Patients
NCT00676403
  1. Tuscaloosa, Alabama
  2. Little Rock, Arkansas
  3. San Diego, California
  4. Santa Monica, California
  5. Aurora, Colorado
  6. Brandon, Florida
  7. Macon, Georgia
  8. Louisville, Kentucky
  9. Baton Rouge, Louisiana
  10. Raleigh, North Carolina
  11. Salisbury, North Carolina
  12. Winston-Salem, North Carolina
  13. Oklahoma City, Oklahoma
  14. Dallas, Texas
  15. Alexandria, Virginia
  16. Innsbruck,
  17. Vienna,
  18. Bad Saarow,
  19. Berlin,
  20. Goettingen,
  21. Mittweida,
  22. Muenchen,
  23. Oldenburg,
  24. Schwerin,
  25. Madrid,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Restless Legs SyndromeA Study to Evaluate the Efficacy and Safety of Cabergoline Compared With Placebo for the Treatment of RLS
NCT00627003
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Restless Legs SyndromePolysomnography Study Of Pregabalin And Pramipexole Versus Placebo In Patients With Restless Legs Syndrome And Associated Sleep Disturbance
NCT00991276
  1. Jasper, Alabama
  2. Phoenix, Arizona
  3. Tucson, Arizona
  4. Little Rock, Arkansas
  5. Little Rock, Arkansas
  6. Burlingame, California
  7. Pasadena, California
  8. Redlands, California
  9. San Diego, California
  10. San Diego, California
  11. Santa Ana, California
  12. Santa Monica, California
  13. Aurora, Colorado
  14. Hallandale Beach, Florida
  15. Miami, Florida
  16. Pembroke Pines, Florida
  17. Spring Hill, Florida
  18. Atlanta, Georgia
  19. Macon, Georgia
  20. Overland Park, Kansas
  21. Crestview Hills, Kentucky
  22. Lexington, Kentucky
  23. Baton Rouge, Louisiana
  24. Chevy Chase, Maryland
  25. Brighton, Massachusetts
  26. Kalamazoo, Michigan
  27. Portage, Michigan
  28. New York, New York
  29. Hickory, North Carolina
  30. Raleigh, North Carolina
  31. Winston Salem, North Carolina
  32. Winston-Salem, North Carolina
  33. Cincinnati, Ohio
  34. Dublin, Ohio
  35. Middleburg Heights, Ohio
  36. Oklahoma City, Oklahoma
  37. Clarks Summit, Pennsylvania
  38. Lafayette Hill, Pennsylvania
  39. Columbia, South Carolina
  40. Austin, Texas
  41. Austin, Texas
  42. Dallas, Texas
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE 12-Week Efficacy And Safety Of Pregabalin In Treating Restless Legs Syndrome (RLS) Subjects
Official Title  ICMJE Randomized Double-Blind, 12-Week Study Of Pregabalin In Subjects With Restless Legs Syndrome
Brief Summary The purpose of this study is to assess efficacy and safety of pregabalin in treating moderate to severe Restless Legs Syndrome in comparison to placebo.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
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, orally administered once a day, 1-3 hours before bedtime for 12 weeks
  • Drug: pregabalin
    pregabalin 150 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 weeks
    Other Name: Lyrica
  • Drug: pregabalin
    pregabalin 300 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 weeks
    Other Name: Lyrica
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: Pregabalin 150 mg/day
    Intervention: Drug: pregabalin
  • Experimental: Pregabalin 300 mg/day
    Intervention: Drug: pregabalin
Publications * Not Provided

*   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 Withdrawn
Actual Enrollment  ICMJE
 (submitted: June 28, 2010)		0
Original Estimated Enrollment  ICMJE
 (submitted: February 1, 2010)		350
Estimated Study Completion Date  ICMJE August 2011
Estimated Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Idiopathic Restless Legs Syndrome with the presence of all four clinical manifestations of RLS:
  • RLS symptoms occur predominantly in the evening
  • RLS history at least 6 months
  • International Restless Legs Study Group Rating Scale (IRLS) greater than or equal to 15 at the beginning and the end of placebo run-in
  • Have greater than or equal to 15 nights with RLS symptoms in the month prior to screening

Exclusion Criteria:

  • Any secondary RLS
  • Current augmentation due to RLS treatment
  • Placebo responders identified during the placebo run-in
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 Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01061372
Other Study ID Numbers  ICMJE A0081184
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
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