Trial · NCT04161027
RCT for Pregabalin in Restless Legs Syndrome in South Korea
NCT04161027, Phase 3, Completed, Seoul National University Hospital
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. RCT for Pregabalin in Restless Legs Syndrome in South Korea. Trials, record NCT04161027. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04161027
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- RCT for Pregabalin in Restless Legs Syndrome in South Korea
- NCT number
- NCT04161027
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 116 participants, actual
- Lead sponsor
- Seoul National University Hospital
- Conditions
- Restless Legs Syndrome
- Interventions
- Pregabalin 75mg, Placebos
- First posted
- 2019-11-13
- Last updated
- 2023-04-24
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | International restless legs scale score | Baseline (week 0) and post-treatment (week 12) | 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. |
| Secondary | Remission rate | Baseline (week 0) and post-treatment (week 12) | A proportion of patients who showed a decrease in IRLS score of 50% or more after treatment. Higher scores mean a better outcome. |
| Secondary | CGI (clinical global impression)-improvement | Post-treatment (week 12) | The amount of RLS symptom improvement measured by physicians. CGI-improvement is a 7-point scale and rated as 1 (Very much improved), 2 (Much improved), 3 (Minimally improved), 4 (No change), 5 (Minimally worse), 6 (Much worse), and 7 (Very much worse). |
| Secondary | 10-cm visual analog scale (VAS) | Baseline (week 0) and post-treatment (week 12) | Changes in 10-cm VAS after 12-week treatment. A VAS score ranges from 0 (no symptoms) to 10 (very severe symptoms). |
| Secondary | Restless legs syndrome (RLS)-6 | Baseline (week 0) and post-treatment (week 12) | Changes in RLS-6 scores after 12-week treatment. A RLS-6 consists of 6 questions for RLS symptoms and a total score ranges from 0 (no symptoms) to 60 (very severe symptoms). |
| Secondary | PSQI (pittsburgh sleep quality index) | Baseline (week 0) and post-treatment (week 12) | Changes in PSQI scores after 12-week treatment. A total PSQI score ranges from 0 to 21, and higher scores indicate worse sleep quality. |
| Secondary | ISI (insomnia severity index) | Baseline (week 0) and post-treatment (week 12) | Changes in ISI scores after 12-week treatment. A total ISI score range from 0 to 28 and categories: 0-7 (No clinically significant insomnia), 8-14 (Subthreshold insomnia), 15-21 (Moderate insomnia), and 22-28 (Severe insomnia) |
| Secondary | Johns Hopkins Restless legs syndrome quality of life | Baseline (week 0) and post-treatment (week 12) | Changes in Johns Hopkins Restless legs syndrome quality of life scores after 12-week treatment. A total score ranges from 0 to 100 and lower scores indicate worse quality of life. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40635537 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04161027
GET https://conductscience.org/api/trials/v1/NCT04161027/registered