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Recruitment Status : Withdrawn (Study withdrawn due to budget (personnel) limitations.)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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Restless Legs Syndrome Drug: Pregabalin (Lyrica) Drug: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pregabalin (Lyrica) for the Treatment of Restless Legs Syndrome
Study Start Date : November 2007
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Restless Legs
Drug Information available for: Pregabalin
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Pregabalin (Lyrica)
Drug: Pregabalin (Lyrica)
50 - 150 mg po qhs for 2 months
Placebo Comparator: 2
Drug: Pregabalin (Lyrica)
50 - 150 mg po qhs for 2 months
Drug: Placebo
50 - 150 mg po qhs for 2 months

Primary Outcome Measures :
  1. International RLS Study Group Severity Scale (IRLS) [ Time Frame: 2 months ]

Secondary Outcome Measures :
  1. Clinical Global Impression (CGI) [ Time Frame: 2 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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. -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00584246

United States, Florida
University of South Florida
Tampa, Florida, United States, 33612
Sponsors and Collaborators
University of South Florida
Principal Investigator: Theresa A Zesiewicz, MD University of South Florida

Responsible Party: Theresa Zesiewicz, MD, Professor of Neurology, University of South Florida Identifier: NCT00584246     History of Changes
Other Study ID Numbers: 3
First Posted: January 2, 2008    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018

Keywords provided by Theresa Zesiewicz, MD, University of South Florida:
Restless legs syndrome

Additional relevant MeSH terms:
Psychomotor Agitation
Restless Legs Syndrome
Pathologic Processes
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Mental Disorders
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs