Pregabalin (Lyrica) for the Treatment of Restless Legs Syndrome

NCT00584246 | Withdrawn Phase 4

• 2 other identifiers: 3105362
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Restless Legs Syndrome

Keywords

Restless legs syndrome; RLS; Pregabalin; Lyrica

Outcome Measures

Primary Outcomes (1)

• International RLS Study Group Severity Scale (IRLS)

  2 months

Secondary Outcomes (1)

• Clinical Global Impression (CGI)

  2 months

Study Arms (2)

1

EXPERIMENTAL

Pregabalin (Lyrica)

Drug: Pregabalin (Lyrica)

2

PLACEBO COMPARATOR

Placebo

Drug: Pregabalin (Lyrica); Drug: Placebo

Interventions

Pregabalin (Lyrica) DRUG

50 - 150 mg po qhs for 2 months

1; 2

Placebo DRUG

50 - 150 mg po qhs for 2 months

2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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. -

You may not qualify if:

• 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. -

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (1)

University of South Florida

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Restless Legs Syndrome

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Theresa A Zesiewicz, MD

  University of South Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 2, 2008
• Study Start: November 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: November 16, 2021

Record last verified: 2021-11

Locations

US (1)