Pregabalin (Lyrica) for the Treatment of Restless Legs Syndrome

This study has been withdrawn prior to enrollment.

(Study withdrawn due to budget (personnel) limitations.)

Sponsor:

Information provided by:

University of South Florida

ClinicalTrials.gov Identifier:

NCT00584246

First received: December 21, 2007

Last updated: June 2, 2008

Last verified: June 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

December 21, 2007

Last Updated Date

June 2, 2008

Start Date ^ICMJE

November 2007

Estimated Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

International RLS Study Group Severity Scale (IRLS) [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00584246 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Clinical Global Impression (CGI) [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Pregabalin (Lyrica) for the Treatment of Restless Legs Syndrome

Official Title ^ICMJE

Pregabalin (Lyrica) for the Treatment of Restless Legs Syndrome

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Restless Legs Syndrome

Intervention ^ICMJE

Drug: Pregabalin (Lyrica)
50 - 150 mg po qhs for 2 months
Drug: Placebo
50 - 150 mg po qhs for 2 months

Study Arm (s)

Experimental: 1
Pregabalin (Lyrica)

Intervention: Drug: Pregabalin (Lyrica)
Placebo Comparator: 2
Placebo
Interventions:
- Drug: Pregabalin (Lyrica)
- Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Withdrawn

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Estimated Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

Any illness that in the investigator's opinion preclude participation in this study.
Pregnancy or lactation.
Concurrent participation in another clinical study.
Current treatment with a dopamine agonist (unless stopped at least 2 weeks prior to baseline).
Dementia or other psychiatric illness that prevents the patient from giving informed consent (Mini Mental Status Exam score less than 24).
Legal incapacity or limited legal capacity.
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.
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).
Presence of severe daytime sleepiness.
Present complaints of somnolence, dizziness, blurred vision, bleeding tendencies, cardiac abnormalities.
Patients taking dopamine agonists for any condition other than RLS. -

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00584246

Other Study ID Numbers ^ICMJE

3, 105362

Has Data Monitoring Committee

Responsible Party

Theresa Zesiewicz, MD, University of South Florida

Study Sponsor ^ICMJE

University of South Florida

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Theresa A Zesiewicz, MD

University of South Florida

Information Provided By

University of South Florida

Verification Date

June 2008

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

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