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Long Term Study Of Pregabalin In Idiopathic Restless Legs Syndrome Patients

Last updated on November 13, 2019

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Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35209 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Idiopathic 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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- idiopathic RLS with the presence of all four clinical manifestations of RLS

- RLS symptoms occur predominantly in the evening

- RLS history at least 6 months

- IRLS => 15 at the beginning and the end of placebo run-in

- Have =>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.
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- Any secondary RLS

- Current augmentation due to RLS treatment

- Placebo responders identified during the placebo run-in

NCT00806026
Pfizer
Completed
Long Term Study Of Pregabalin In Idiopathic Restless Legs Syndrome Patients

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Descriptive Information
Brief Title  ICMJE Long Term Study Of Pregabalin In Idiopathic Restless Legs Syndrome Patients
Official Title  ICMJE Randomized, Double Blind, 12-Month Study Of Pregabalin In Subjects With Restless Legs Syndrome
Brief SummaryThis purpose of this study is to investigate the efficacy and tolerability of pregabalin in treating idiopathic RLS patients for up to 12 months.
Detailed DescriptionNot 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 Idiopathic Restless Legs Syndrome
Intervention  ICMJE
  • Drug: placebo and pregabalin
    following 3 months placebo treatment, subjects are to be re-distributed to pregabalin 300 mg per day for 9 months. Both placebo and pregabalin are to be administered orally once a day, 1-3 hours before bedtime.
    Other Name: Lyrica
  • Drug: pramipexol
    following 3 months placebo treatment, subjects are to be re-distributed to pramipexol 0.25mg per day for 9 months. Both placebo and pramipexol are to be administered orally once a day, 1-3 hours before bedtime.
    Other Name: Mirapex
  • Drug: pramipexol
    following 3 months placebo treatment, subjects are to be re-distributed to pramipexol 0.5mg per day for 9 months. Both placebo and pramipexol are to be administered orally once a day, 1-3 hours before bedtime.
    Other Name: Mirapex
  • Drug: Pregabalin
    pregabalin 300 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 months
    Other Name: Lyrica
  • Drug: pramipexol
    pramipexol 0.25 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 months
    Other Name: Mirapex
  • Drug: pramipexol
    pramipexol 0.5 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 months
    Other Name: Mirapex
Study Arms  ICMJE
  • Experimental: PBO/PGB 300 mg
    Intervention: Drug: placebo and pregabalin
  • Active Comparator: PBO/PPX 0.25 mg
    Intervention: Drug: pramipexol
  • Active Comparator: PBO/PPX 0.5 mg
    Intervention: Drug: pramipexol
  • Experimental: PGB 300 mg
    Intervention: Drug: Pregabalin
  • Active Comparator: PPX 0.25 mg
    Intervention: Drug: pramipexol
  • Active Comparator: PPX 0.5 mg
    Intervention: Drug: pramipexol
Publications *Allen RP, Chen C, Garcia-Borreguero D, Polo O, DuBrava S, Miceli J, Knapp L, Winkelman JW. Comparison of pregabalin with pramipexole for restless legs syndrome. N Engl J Med. 2014 Feb 13;370(7):621-31. doi: 10.1056/NEJMoa1303646.


*   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: May 26, 2011)
731
Original Estimated Enrollment  ICMJE
 (submitted: December 9, 2008)
700
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion DateMay 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • idiopathic RLS with the presence of all four clinical manifestations of RLS
  • RLS symptoms occur predominantly in the evening
  • RLS history at least 6 months
  • IRLS => 15 at the beginning and the end of placebo run-in
  • Have =>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 Austria,   Finland,   Germany,   Italy,   Netherlands,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00806026
Other Study ID Numbers  ICMJE A0081186
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateAugust 2012

ICMJE     Data element required by the

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

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