A Phase 3 interventional study of Pregabalin 75mg and Placebos in Restless Legs Syndrome, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-04-24.
Sponsored by Seoul National University Hospital · Phase 3, Interventional, and Treatment
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.
Objectives: To assess the treatment efficacy and tolerability of pregabalin in patients with idiopathic restless legs syndrome (RLS) in South Korea.
Study Design: A randomized, double-blind, placebo-controlled, multicenter clinical trial Study period: total 14 weeks: 2 weeks for placebo run in period and 12 weeks treatment after randomization (titration for 4 weeks and maintenance for 8 weeks).
Subjects: a total number of 100 participants (randomly assigned 1:1 to pregabalin or placebo). The sample number was calculated based on a superiority design, 1-sided, alpha 0.05 with power 80% and drop rate 10%.
Inclusion criteria: adults aged between 19-80 and diagnosed with idiopathic RLS with IRLS score of 15 or more.
Exclusion criteria: Secondary RLS; 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; other comorbid sleep disorders or shift workers.
Treatment schedule and dose
Primary outcome: changes in IRLS score after 12-week treatment. Secondary outcomes: remission rate (decrease in IRLS score of 50% or more), CGI (clinical global impression)-improvement, changes in 10-cm visual analog scale (VAS), RLS-6, PSQI (pittsburgh sleep quality index), ISI (insomnia severity index), Johns Hopkins RLS QoL after 12-week treatment.
Statistical analysis: ANCOVA for changes in IRLS score with a baseline IRLS score as a covariate.
Tolerability: Safety profiles and Liverpool Adverse Event Profile (LAEP) will be assessed.
500 studies on the registry are indexed under Psychomotor Agitation; 55 are open to participants now.
This study's enrollment of 116 is above the median of 90 across 413 interventional studies indexed under Psychomotor Agitation.
Browse Psychomotor Agitation studies →Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
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Exclusion Criteria:
Drug: Pregabalin 75mg
Drug: Placebos
Pregabalin 75 mg capsule
Placebo capsule
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.
Time frame: Baseline (week 0) and post-treatment (week 12)
Remission rate
A proportion of patients who showed a decrease in IRLS score of 50% or more after treatment. Higher scores mean a better outcome.
Time frame: Baseline (week 0) and post-treatment (week 12)
CGI (clinical global impression)-improvement
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).
Time frame: Post-treatment (week 12)
10-cm visual analog scale (VAS)
Changes in 10-cm VAS after 12-week treatment. A VAS score ranges from 0 (no symptoms) to 10 (very severe symptoms).
Time frame: Baseline (week 0) and post-treatment (week 12)
Restless legs syndrome (RLS)-6
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).
Time frame: Baseline (week 0) and post-treatment (week 12)
PSQI (pittsburgh sleep quality index)
Changes in PSQI scores after 12-week treatment. A total PSQI score ranges from 0 to 21, and higher scores indicate worse sleep quality.
Time frame: Baseline (week 0) and post-treatment (week 12)
ISI (insomnia severity index)
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)
Time frame: Baseline (week 0) and post-treatment (week 12)
Johns Hopkins Restless legs syndrome quality of life
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.
Time frame: Baseline (week 0) and post-treatment (week 12)
Plan to share: No
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Seoul National University Hospital