Pregabalin (Lyrica) for the Treatment of Restless Legs Syndrome

Phase 4

Withdrawn

• Conditions: Restless Legs Syndrome
• Interventions: Drug: Pregabalin (Lyrica); Drug: Placebo

• Registration Number: NCT00584246
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2007-12-21
• Study First Submitted QC: 2007-12-31
• Study First Posted: 2008-01-02
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-08
• Last Update Posted: 2021-11-16

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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. -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Pregabalin (Lyrica)	Pregabalin (Lyrica)
2	Placebo	Placebo
2	Pregabalin (Lyrica)	Placebo

Primary Outcome Measures

Name	Time	Method
International RLS Study Group Severity Scale (IRLS)	2 months

Secondary Outcome Measures

Name	Time	Method
Clinical Global Impression (CGI)	2 months

Trial Locations

Locations (1)

University of South Florida; 🇺🇸 Tampa, Florida, United States