RCT for Pregabalin in Restless Legs Syndrome in South Korea

NCT04161027 | Completed Phase 3

• 1 other identifier: 1903-121-1021
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Restless Legs Syndrome

Keywords

Restless legs syndrome; pregabalin; Willis-Ekbom disease

Outcome Measures

Primary Outcomes (1)

• International restless legs scale score

  Changes in International restless legs scale (IRLS) score after 12-week treatment. IRLS is used to assess the severity of patient's RLS symptoms. A total score ranges from 0 to 40 and higher scores mean more severe symptoms. Therefore, greater differences in IRLS scores between baseline and post-treatment mean a better outcome.

  Baseline (week 0) and post-treatment (week 12)

Secondary Outcomes (7)

• Remission rate

  Baseline (week 0) and post-treatment (week 12)

• CGI (clinical global impression)-improvement

  Post-treatment (week 12)

• 10-cm visual analog scale (VAS)

  Baseline (week 0) and post-treatment (week 12)

• Restless legs syndrome (RLS)-6

  Baseline (week 0) and post-treatment (week 12)

• PSQI (pittsburgh sleep quality index)

  Baseline (week 0) and post-treatment (week 12)

Study Arms (2)

Pregabalin

EXPERIMENTAL

Drug: Pregabalin 75mg

Placebo

PLACEBO COMPARATOR

Drug: Placebos

Interventions

Pregabalin 75mg DRUG

Pregabalin 75 mg capsule

Pregabalin

Placebos DRUG

Placebo capsule

Placebo

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (1)

• Sunwoo JS, Cho YW, Shin WC, Byun JI, Shin JW, Jung KY. Efficacy and Safety of Pregabalin for Restless Legs Syndrome in Korean Adults: A Randomized, Double-Blind, Placebo-Controlled Trial. J Clin Neurol. 2025 Jul;21(4):325-331. doi: 10.3988/jcn.2025.0092.

  PMID: 40635537 DERIVED

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

• Ki-Young Jung, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A randomized, double-blind, placebo-controlled, multicenter clinical trial. Study subjects will be recruited from 4 medical centers in South Korea.

Study Record Dates

• First Submitted: November 6, 2019
• First Posted: November 13, 2019
• Study Start: February 24, 2020
• Primary Completion: April 4, 2022
• Study Completion: April 4, 2022
• Last Updated: April 24, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)