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

Last updated on December 17, 2017

FOR MORE INFORMATION
Study Location
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+ 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

NCT01061372
Pfizer
Withdrawn
12-Week Efficacy And Safety Of Pregabalin In Treating Restless Legs Syndrome (RLS) Subjects

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12-Week Efficacy And Safety Of Pregabalin In Treating Restless Legs Syndrome (RLS) Subjects
Randomized Double-Blind, 12-Week Study Of Pregabalin In Subjects With Restless Legs Syndrome
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Restless Legs Syndrome
  • 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
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: Pregabalin 150 mg/day
    Intervention: Drug: pregabalin
  • Experimental: Pregabalin 300 mg/day
    Intervention: Drug: pregabalin
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
August 2011
August 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01061372
A0081184
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

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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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