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Pregabalin (Lyrica) for the Treatment of Restless Legs Syndrome

Primary Purpose

Restless Legs Syndrome

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Pregabalin (Lyrica)
Placebo
Sponsored by
University of South Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Restless Legs Syndrome focused on measuring Restless legs syndrome, RLS, Pregabalin, Lyrica

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. -

Sites / Locations

  • University of South Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Pregabalin (Lyrica)

Placebo

Outcomes

Primary Outcome Measures

International RLS Study Group Severity Scale (IRLS)

Secondary Outcome Measures

Clinical Global Impression (CGI)

Full Information

First Posted
December 21, 2007
Last Updated
November 8, 2021
Sponsor
University of South Florida
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1. Study Identification

Unique Protocol Identification Number
NCT00584246
Brief Title
Pregabalin (Lyrica) for the Treatment of Restless Legs Syndrome
Official Title
Pregabalin (Lyrica) for the Treatment of Restless Legs Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Study stopped due to budget (personnel) limitations.
Study Start Date
November 2007 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of South Florida

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Restless Legs Syndrome
Keywords
Restless legs syndrome, RLS, Pregabalin, Lyrica

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Pregabalin (Lyrica)
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Pregabalin (Lyrica)
Intervention Description
50 - 150 mg po qhs for 2 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
50 - 150 mg po qhs for 2 months
Primary Outcome Measure Information:
Title
International RLS Study Group Severity Scale (IRLS)
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Clinical Global Impression (CGI)
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theresa A Zesiewicz, MD
Organizational Affiliation
University of South Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States

12. IPD Sharing Statement

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Pregabalin (Lyrica) for the Treatment of Restless Legs Syndrome

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