RCT for Pregabalin in Restless Legs Syndrome in South Korea

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-24

Study Completion Date

2022-04-04

Brief Summary

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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.

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Detailed Description

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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

\- Placebo responders, who showed a decrease of IRLS score of 40% or more, are excluded before randomization. Subjects will randomly assigned to receive either pregabalin or placebo with a 1:1 allocation. A starting dose is 75 mg/day for 2 weeks (taken 1-2 hours before habitual bedtime). At the visit of 2 weeks and 4 weeks, a dose can be titrated by 75-150 mg according to the response and tolerability. A dose ranging 75-300 mg per day will be maintained for 8 weeks.

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.

Conditions

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Restless Legs Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Pregabalin

Group Type EXPERIMENTAL

Pregabalin 75mg

Intervention Type DRUG

Pregabalin 75 mg capsule

Placebo

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

Placebo capsule

Interventions

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Pregabalin 75mg

Pregabalin 75 mg capsule

Intervention Type DRUG

Placebos

Placebo capsule

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No