NCT01537042已完成3 期
A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group, Polysomnography Study to Investigate Safety and Efficacy of the Rotigotine Transdermal Patch in Subjects With Restless Legs Syndrome and End-Stage Renal Disease Requiring Hemodialysis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 15
- 主要终点
- Ratio From Baseline to the End of the 2-week Maintenance Period in Periodic Limb Movement Index (PLMI)
研究概览
简要总结
This is a sleep laboratory study to evaluate the efficacy and safety of Rotigotine in subjects with Restless Legs Syndrome and End-Stage Renal Disease requiring hemodialysis.
The objectives are to demonstrate superiority of Rotigotine against Placebo as well as to investigate the effect of Rotigotine on quality of life and sleep.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •End-Stage Renal Disease (ESRD) requiring hemodialysis and regular dialysis schedule
- •Fulfillment of pre-defined criteria of hematology parameters
- •Diagnosis of Restless Legs (RLS) based on the 4 cardinal diagnostic clinical features according to the International Restless Legs Syndrome Study Group
- •Initial response to previous dopaminergic treatment for RLS, or has had no previous dopaminergic treatment (ie, de novo)
- •Score of ≥ 15 points on the IRLS (indicating moderate to severe RLS) at Baseline
- •Score of ≥ 11 points on the RLS-DI (Diagnostic Index) at Baseline
- •Score of ≥ 4 points on the Clinical Global Impressions (CGI) Item 1 assessment (indicating moderately ill) at Baseline
- •Scores ≥ 15 Periodic Limb Movements (PLMs) per hour on the Periodic Limb Movement Index (PLMI) based on Polysomnography (PSG) (recorded during the second night) as assessed by the investigator at Baseline
排除标准
- •Clinically relevant Polyneuropathy or Varicosis which cannot be clearly differentiated from RLS symptoms in the opinion of the investigator
- •Clinically relevant concomitant diseases, such as Attention Deficit Hyperactivity Disorder, Painful Legs, and Moving Toes
- •Other central nervous system diseases
- •Evidence of an impulse control disorder according to the modified Minnesota Impulsive Disorders Interview (mMIDI)
- •Lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response ('yes') to either Question 4 or Question 5 of the Columbia-Suicidality Severity Rating Scale (C-SSRS) at Screening (Visit 1) or Baseline (Visit 2)
- •Prior history of psychotic episodes
- •History of symptomatic (not asymptomatic) Orthostatic Hypotension
- •Clinically relevant Cardiovascular Disease
- •Clinically relevant Venous or Arterial Peripheral Vascular Disease
- •Malignant Neoplastic Disease requiring therapy within 12 months prior to Screening (Visit 1)
- •Treatment with any of the following drug classes: neuroleptics, norepinephrine and dopamine reuptake inhibitors (bupropion), gabapentin, budipine, dopamine antagonist antiemetics (except domperidone), opioids, monoamine oxidase (MAO) inhibitors, catechol-O-methyltransferase (COMT) inhibitors, or psychostimulants (eg, amphetamines)
- •Subject is pregnant, nursing, or is a woman of childbearing potential who is not surgically sterile, 2 years postmenopausal, or does not consistently use 2 combined effective methods of contraception (including at least 1 barrier method), unless sexually abstinent
- •Previous treatment with dopamine agonists within a period of 14 days prior to Baseline (Visit 2), or L-dopa within 7 days prior to Baseline (Visit 2)
- •Medical history indicating intolerability to dopaminergic therapy (if pretreated) or has experienced Augmentation (Garcia-Borreguero and Williams, 2010) when previously treated with any dopaminergic agent
- •Subject has received previous treatment with Rotigotine
- •Known hypersensitivity to any of the components of the study medication, such as a history of significant Skin Hypersensitivity to adhesives, known Hypersensitivity to other transdermal medications, or unresolved Contact Dermatitis
研究组 & 干预措施
Rotigotine
Experimental
Rotigotine Transdermal Patch
1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h.
干预措施: Rotigotine (Drug)
Placebo
Placebo Comparator
Transdermal patch matched according to patch size and appearance.
干预措施: Placebo (Drug)
结局指标
主要结局
Ratio From Baseline to the End of the 2-week Maintenance Period in Periodic Limb Movement Index (PLMI)
时间窗: From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period
The PLMI is defined as Periodic Limb Movements (PLMs)/ total time in bed in hours. PLMs are measured by Polysomnography (PSG). The reduction of the PLMI is reflected in terms of the ratio from Baseline to the end of the Maintenance Period and was calculated as \[PLMI at end of Maintenance Period (MP)\] / \[PLMI at Baseline\]. A PLMI Ratio \<1 indicates an improvement from Baseline to the end of the 2-week MP.
次要结局
- Change From Baseline in the Periodic Limb Movements Index (PLMI) to the End of the Maintenance Period(From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period)
- Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 1 to the End of the Maintenance Period(From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period)
- Change From Baseline in the Periodic Limb Movement During Sleep Arousal Index (PLMSAI) to the End of the Maintenance Period(From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period)
- Change From Baseline in Sleep Efficiency to the End of the Maintenance Period(From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period)
- Change From Baseline in the International Restless Legs Syndrome Study Group Rating Scale (IRLS) Sum Score to the End of the Maintenance Period(From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period)
- Change From Baseline in Clinical Global Impressions (CGI) Item 1 Score(Visit 2 (Baseline); Visit 6 (End of Maintence Period))
- Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 2 to the End of the Maintenance Period(From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period)
- Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 4 to the End of the Maintenance Period(From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period)
- Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 5 to the End of the Maintenance Period(From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period)
- Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 3 to the End of the Maintenance Period(From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period)
- Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 6 to the End of the Maintenance Period(From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period)
- Change From Baseline in the Restless Legs-Quality of Life (RLS-QoL) Total Score to the End of the Maintenance Period(From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period)
- Change From Baseline in the Short-Form-36 (SF-36) Item Questionnaire Mental Component Summary (MCS) to the End of the Maintenance Period(From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period)
- Change From Baseline in the Short-Form-36 (SF-36) Item Questionnaire Physical Component Summary (PCS) to the End of the Maintenance Period(From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period)
研究者
研究点 (15)
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