Pregabalin (Lyrica) for the Treatment of Restless Legs Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00584246
Recruitment Status : Withdrawn (Study withdrawn due to budget (personnel) limitations.)
First Posted : January 2, 2008
Last Update Posted : April 20, 2018
Information provided by (Responsible Party):
Theresa Zesiewicz, MD, University of South Florida

December 21, 2007
January 2, 2008
April 20, 2018
November 2007
May 2008   (Final data collection date for primary outcome measure)
International RLS Study Group Severity Scale (IRLS) [ Time Frame: 2 months ]
Same as current
Complete list of historical versions of study NCT00584246 on Archive Site
Clinical Global Impression (CGI) [ Time Frame: 2 months ]
Same as current
Not Provided
Not Provided
Pregabalin (Lyrica) for the Treatment of Restless Legs Syndrome
Pregabalin (Lyrica) for the Treatment of Restless Legs Syndrome
This study will evaluate the safety and efficacy of Pregabalin (Lyrica) in treating patients with Restless Legs Syndrome (RLS) in a double-blind, placebo-controlled trial.
Not Provided
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Restless Legs Syndrome
  • Drug: Pregabalin (Lyrica)
    50 - 150 mg po qhs for 2 months
  • Drug: Placebo
    50 - 150 mg po qhs for 2 months
  • Experimental: 1
    Pregabalin (Lyrica)
    Intervention: Drug: Pregabalin (Lyrica)
  • Placebo Comparator: 2
    • Drug: Pregabalin (Lyrica)
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
May 2008
May 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Outpatients with RLS diagnosed by a movement disorder specialist/ Sleep specialist .
  2. Patients must report some degree of pain which occurs on a regular basis.
  3. Age 18 years to 80 years.
  4. Women of child-bearing potential must use a reliable method of contraception and must provide a negative pregnancy test at entry into the study.
  5. Stable doses of all medications for 30 days prior to study entry and for the duration of the study.
  6. Willing and able to provide informed consent.
  7. Willing to comply with protocol. -

Exclusion Criteria:

  1. Any illness that in the investigator's opinion preclude participation in this study.
  2. Pregnancy or lactation.
  3. Concurrent participation in another clinical study.
  4. Current treatment with a dopamine agonist (unless stopped at least 2 weeks prior to baseline).
  5. Dementia or other psychiatric illness that prevents the patient from giving informed consent (Mini Mental Status Exam score less than 24).
  6. Legal incapacity or limited legal capacity.
  7. Presence of severe renal disease BUN 50% greater than normal, Patients must have evidence from their PCP or Urologists of normal PSA and urodynamic tests within the last 12 month. Normal BUN levels should be within a range of 5 to 20 mg/ d L and creatinine between .7 and 1.4 mg/ d L. Labs will be requested from PCP.
  8. Presence of major hepatic impairment (Cirrhosis, Viral Hepatitis, Nonalcoholic Steatohepatitis, Wilson's disease, or Hemochromatosis). LFT must show non-clinically significant results (Albumin range 3.0-6.0; Alkaline phosphatase range 40-150; ALT range 0-55; AST range 5-34).
  9. Presence of severe daytime sleepiness.
  10. Present complaints of somnolence, dizziness, blurred vision, bleeding tendencies, cardiac abnormalities.
  11. Patients taking dopamine agonists for any condition other than RLS. -
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Theresa Zesiewicz, MD, University of South Florida
University of South Florida
Not Provided
Principal Investigator: Theresa A Zesiewicz, MD University of South Florida
University of South Florida
April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP