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

Last updated on August 9, 2018

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

NCT00676403
Pfizer
Completed
Lyrica Dose Response Study With Restless Legs Syndrome (RLS) Patients

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Lyrica Dose Response Study With Restless Legs Syndrome (RLS) Patients
Randomized, Double-Blind, 6-Week Study Of Pregabalin In Subjects With Restless Legs Syndrome
To test the effectiveness and tolerability of Lyrica at various dose levels in RLS patients
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Restless Legs Syndrome
  • 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
  • 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
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.
 
Completed
137
January 2009
January 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Germany,   Spain,   United States
 
 
NCT00676403
A0081183
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2010

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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