Randomized, Double Blind, 12-Month Study Of Pregabalin In Subjects With Restless Legs Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 731
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Augmentation
研究概览
简要总结
This purpose of this study is to investigate the efficacy and tolerability of pregabalin in treating idiopathic RLS patients for up to 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •idiopathic RLS with the presence of all four clinical manifestations of RLS
- •RLS symptoms occur predominantly in the evening
- •RLS history at least 6 months
- •IRLS => 15 at the beginning and the end of placebo run-in
- •Have =>15 nights with RLS symptoms in the month prior to screening
排除标准
- •Any secondary RLS
- •Current augmentation due to RLS treatment
- •Placebo responders identified during the placebo run-in
研究组 & 干预措施
PBO/PGB 300 mg
干预措施: placebo and pregabalin (Drug)
PBO/PPX 0.25 mg
干预措施: pramipexol (Drug)
PBO/PPX 0.5 mg
干预措施: pramipexol (Drug)
PGB 300 mg
干预措施: Pregabalin (Drug)
PPX 0.25 mg
干预措施: pramipexol (Drug)
PPX 0.5 mg
干预措施: pramipexol (Drug)
结局指标
主要结局
Percentage of Participants With Augmentation
时间窗: Baseline up to Week 52
Augmentation was worsening of RLS symptoms, attributable to a specific long-term therapeutic intervention for RLS. Percentage of participants with augmentation was evaluated by centralized evaluation board using a set of assessment criteria for potential augmentation which included structured interview for diagnosis of augmentation during RLS treatment (SIDA-RLS), augmentation severity rating scale (ASRS), clinical judgment. ASRS measures severity of augmentation and consist of three items to be completed by clinician. Clinician would score participants' answers by comparing post-baseline evaluations to those at baseline. ASRS total score range: 0-24, with higher score indicating more severe augmentation.
Restless Legs Syndrome (RLS) Symptom Severity
时间窗: Baseline
International Restless Legs Syndrome Study Group Rating Scale (IRLS) is psychometrically and clinically valid and reliable clinician-administered instrument used to assess the severity of RLS. It assesses RLS symptom severity and impact on daily living and is comprised of 10 items, scored on 0 to 4 scale, where lower score indicates lower symptom severity/impact on living. Two subscale scores are symptom severity (6 items) ranging from 0-24 (lower score indicates lower symptom severity) and impact on daily living (3 items) ranging from 0-12 (lower score indicates lower impact on living). Item 3 is unrelated to the other items. The global score is calculated from all 10 items, range from 0 to 40, where lower scores reflect lower severity and better quality of life.
Percentage of Participants Responding to Treatment at Week 12
时间窗: Week 12
CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. Responders were defined as participants who report CGI-I score of "very much improved" or "much improved".
Change From Baseline in the RLS Symptom Severity at Week 12
时间窗: Baseline, Week 12
IRLS is psychometrically and clinically valid and reliable clinician-administered instrument used to assess the severity of RLS. It assesses RLS symptom severity and impact on daily living and is comprised of 10 items, scored on 0 to 4 scale, where lower score indicates lower symptom severity/impact on living. Two subscale scores are symptom severity (6 items) ranging from 0-24 (lower score indicates lower symptom severity) and impact on daily living (3 items) ranging from 0-12 (lower score indicates lower impact on living). Item 3 is unrelated to the other items. The global score is calculated from all 10 items, range from 0 to 40, where lower scores reflect lower severity and better quality of life.
次要结局
- Subjective Sleep Questionnaire (SSQ): Latency Subscale Score at Week 12(Week 12)
- Change From Baseline in SSQ: Subjective WASO at Week 12(Baseline, Week 12)
- Subjective Sleep Questionnaire (SSQ): Quality of Sleep Subscale Score at Week 12(Week 12)
- RLS-Next Day Impact (RLS-NDI)(Baseline)
- Subjective Sleep Questionnaire (SSQ): Subjective Waking After Sleep Onset (WASO)(Baseline)
- Limb Pain-Visual Analog Scale (Limb Pain-VAS)(Baseline)
- Change From Baseline in Limb Pain-VAS at Week 12(Baseline, Week 12)
- Severity of Augmentation Symptoms at Week 12(Week 12)
- Clinical Global Impressions-Severity (CGI-S) at Week 12(Week 12)
- Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 12(Week 12)
- Subjective Sleep Questionnaire (SSQ): Hours of Sleep Subscale Score at Week 12(Week 12)
- Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP) at Week 12(Week 12)
- Subjective Sleep Questionnaire (SSQ): Number of Awakenings Subscale Score at Week 12(Week 12)
- Change From Baseline in RLS-NDI at Week 12(Baseline, Week 12)
- Number of Participants With Medical Outcomes Study-Sleep Scale (MOS-SS)- Optimal Sleep at Week 12(Week 12)
- Profile of Mood State (POMS) at Week 12(Week 12)
- Restless Legs Syndrome-Quality of Life Scale (RLS-QoL) at Week 12(Week 12)
- Medical Outcomes Study-Short Form 36 (SF-36) at Week 12(Week 12)