NCT04161027 is a Phase 3 clinical trial of Pregabalin 75mg in Restless Legs Syndrome, sponsored by Seoul National University Hospital.

Who is sponsoring NCT04161027?

NCT04161027 is sponsored by Seoul National University Hospital.

What drugs are being tested in NCT04161027?

Interventions in NCT04161027: Pregabalin 75mg, Placebos.

What condition does NCT04161027 study?

NCT04161027 studies Restless Legs Syndrome.

Is NCT04161027 still recruiting?

NCT04161027 is currently completed. Last updated 24 April 2023.

Last reviewed 2023-04-24 · How we verify

NCT04161027

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

RCT for Pregabalin in Restless Legs Syndrome in South Korea

Completed Phase 3 Last updated 24 April 2023

What this trial tests

Phase 3 trial testing Pregabalin 75mg in Restless Legs Syndrome in 116 participants. Completed in 4 April 2022.

Timeline

24 February 2020

Primary endpoint
4 April 2022

4 April 2022

Quick facts

Lead sponsor	Seoul National University Hospital
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	116
Start date	24 February 2020
Primary completion	4 April 2022
Estimated completion	4 April 2022
Sites	1 location across South Korea

Drugs / interventions tested

Pregabalin 75mg — full drug profile →
Placebos — full drug profile →

Conditions studied

Restless Legs Syndrome — all drugs for Restless Legs Syndrome →

Sponsor

Seoul National University Hospital

Who can join

Adults 19 to 80, any sex, with Restless Legs Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Treatment initiation and utilization patterns of pharmacotherapies for early-onset idiopathic restless legs syndrome.
Costales B, Vouri SM, Brown JD, Setlow B, et al · · 2022 · cited 3× · PMID 35605349 · DOI 10.1016/j.sleep.2022.05.003
Efficacy and Safety of Pregabalin for Restless Legs Syndrome in Korean Adults: A Randomized, Double-Blind, Placebo-Controlled Trial.
Sunwoo JS, Cho YW, Shin WC, Byun JI, et al · · 2025 · cited 2× · PMID 40635537 · DOI 10.3988/jcn.2025.0092

Verify or expand the search:

Other trials of Pregabalin 75mg

Trials testing the same drug.

NCT06271486 — Pregabalin in Treatment of Postdural Puncture Headache · Phase 3 · completed
NCT06187922 — Effect of Perioperative Oral Pregabalin in Total Knee Replacement · Phase 4 · unknown
NCT04666714 — Efficacy and Safety of Praga Formulation in the Treatment of Neuropathic Pain · Phase 3 · recruiting
NCT05460871 — Pregabalin for Central Sensitization in TKA · Phase 4 · terminated
NCT06025474 — Comparison of Vortioxetine Versus Other Antidepressants With Pregabalin Augmentation in Burning Mouth Syndrome · Phase 3 · unknown

Other recruiting trials for Restless Legs Syndrome

Currently open trials in the same condition.

NCT06889324 — Efficacy of Vibration Therapy on Restless Legs Syndrome and Sleep Disturbances Among Patients Undergoing Hemodialysis · NA · active not recruiting
NCT06866132 — Response to an Investigational Device in Patients With Restless Legs Syndrome · NA · active not recruiting
NCT06684782 — Prevalence and Characteristics of Restless Leg Syndrome in Thai Patients With Parkinson's Disease · recruiting
NCT06806891 — Restless Leg Syndrome: Is There a Response to Buddhist Walking Meditation in Hemodialysis · NA · recruiting
NCT06570941 — Benefits of a Cannabidiolic Acid Topical Cream for the Treatment of Restless Leg Syndrome · Phase 1, PHASE2 · active not recruiting

Other Seoul National University Hospital trials

Trials by the same sponsor.

NCT07262944 — EOI Block in Otoplasty With Rib Cartilage Graft · NA · recruiting
NCT07464210 — Nemtabrutinib, Bortezomib, and Rituximab for WM · Phase 2 · not yet recruiting
NCT07550803 — Effect of Intraoperative Dexamethasone on Early Postoperative Sleep Quality in Patients Undergoing Nasal Surgery · NA · not yet recruiting
NCT07522138 — Home-based Self-exercise in Patients With Parkinson's Disease: A Feasibility Study · NA · not yet recruiting
NCT07476651 — Scout Dose of Resin Microspheres · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04161027 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Seoul National University Hospital
Last refreshed: 24 April 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04161027.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing