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Long Term Study Of Pregabalin In Idiopathic Restless Legs Syndrome Patients

Last updated on November 9, 2018

FOR MORE INFORMATION
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.
Show details

- 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.
Show details

- 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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Long Term Study Of Pregabalin In Idiopathic Restless Legs Syndrome Patients
Randomized, Double Blind, 12-Month Study Of Pregabalin In Subjects With Restless Legs Syndrome
This purpose of this study is to investigate the efficacy and tolerability of pregabalin in treating idiopathic RLS patients for up to 12 months.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Idiopathic Restless Legs Syndrome
  • 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
  • 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
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.
 
Completed
731
May 2011
May 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Finland,   Germany,   Italy,   Netherlands,   Spain,   Sweden,   United Kingdom,   United States
 
 
NCT00806026
A0081186
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2012

ICMJE     Data element required by the

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

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