RCT for Pregabalin in Restless Legs Syndrome in South Korea

• Status: Recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This randomized, double-blind, placebo-controlled, multicenter clinical trial is designed to to assess the treatment efficacy and tolerability of pregabalin in patients with idiopathic restless legs syndrome in South Korea.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Treatments: Pregabalin

Criteria

Inclusion Criteria:

• IRLS (international restless legs scale) score ≥ 15

• RLS symptom occurring ≥ 3 times/week and persisting over ≥ 6 months

• Drug-naive patients or those who stop taking RLS drugs for ≥ 1 week before screening

Exclusion Criteria:

• Secondary RLS (including iron deficiency anemia, pregnancy, chronic kidney disease [eGFR < 60 mL/min/1.73 m2], peripheral neuropathy, others)

• Serum Ferritin < 10 μg/L or history of oral iron therapy within 3 months or intravenous iron therapy within 1 year

• Severe comorbid medical or psychiatric disorders

• history of pregabalin or gabapentin treatment within 3 months

• High risk of obstructive sleep apnea by STOP-BANG questionnaire

• Other comorbid sleep disorders or shift workers

• Hypersensitivity to pregabalin

• Galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption