Pregabalin (Lyrica) for the Treatment of Restless Legs Syndrome

Restless Legs Syndrome Clinical Trial

Official title:

Pregabalin (Lyrica) for the Treatment of Restless Legs Syndrome

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00584246
• Other study ID #: 3
• Secondary ID: 105362
• Status: Withdrawn
• Phase: Phase 4
• Start date: November 2007
• Est. completion date: May 2008

Study information

• Verified date: November 2021
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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. -

Related Conditions & MeSH terms

• Psychomotor Agitation
• Restless Legs Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
United States	University of South Florida	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	International RLS Study Group Severity Scale (IRLS)		2 months
Secondary	Clinical Global Impression (CGI)		2 months