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Pregabalin (Lyrica) for the Treatment of Restless Legs Syndrome

NCT ID: NCT00584246

Last Updated: 2021-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2008-05-31

Brief Summary

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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

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Conditions

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Restless Legs Syndrome

Keywords

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Restless legs syndrome RLS Pregabalin Lyrica

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

Pregabalin (Lyrica)

Group Type EXPERIMENTAL

Pregabalin (Lyrica)

Intervention Type DRUG

50 - 150 mg po qhs for 2 months

2

Placebo

Group Type PLACEBO_COMPARATOR

Pregabalin (Lyrica)

Intervention Type DRUG

50 - 150 mg po qhs for 2 months

Placebo

Intervention Type DRUG

50 - 150 mg po qhs for 2 months

Interventions

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Pregabalin (Lyrica)

50 - 150 mg po qhs for 2 months

Intervention Type DRUG

Placebo

50 - 150 mg po qhs for 2 months

Intervention Type DRUG

Eligibility Criteria

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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. -
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of South Florida

OTHER

Sponsor Role lead

Responsible Party

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Theresa Zesiewicz, MD

Professor of Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Theresa A Zesiewicz, MD

Role: PRINCIPAL_INVESTIGATOR

University of South Florida

Locations

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University of South Florida

Tampa, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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105362

Identifier Type: -

Identifier Source: secondary_id

3

Identifier Type: -

Identifier Source: org_study_id