Pregabalin (Lyrica) for the Treatment of Restless Legs Syndrome

University of South Florida

Status and phase: Withdrawn; Phase 4

Conditions: Restless Legs Syndrome

Treatments: Drug: Placebo; Drug: Pregabalin (Lyrica)

Study type: Interventional

Funder types: Other

Identifiers

NCT00584246

3

105362

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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. -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Pregabalin (Lyrica)

Treatment:

Drug: Pregabalin (Lyrica)

2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Pregabalin (Lyrica)

Drug: Placebo