NCT01382901已完成2 期
A Phase 2a Study Evaluating the Efficacy and Safety of a Novel Intravenous (IV) Iron Preparation (VIT-45) in the Treatment of Restless Legs Syndrome (RLS)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 45
- 主要终点
- International Restless Legs Syndrome (IRLS) Total Score
研究概览
简要总结
The purpose of this study was to evaluate the safety of 2 dosage regimens of Intravenous (IV) iron Ferric Carboxymaltose (FCM) in comparison to placebo in patients with Restless Legs Syndrome (RLS)
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
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
- •Male or female subjects > or = to 18 years old, and able to give informed consent to the study.
- •RLS signs and symptoms affirming diagnosis. The IRLS Diagnostic Criteria for RLS must be met.
- •Subjects have RLS symptoms > or = to 5 nights per week for at least the past 3 months.
- •A baseline score > or = to 15 on the IRLS Rating Scale.
- •At least one leg with an average baseline Periodic Leg Movement while asleep (PLMS) > or = to 15 movements per hour and at least 3 days of baseline PLMS data is measurable in each leg.
- •Subjects on anti-depressants, sleep medications, dopamine agonists, benzodiazepines, narcotics or other RLS treatments must be off therapy at least one week or 5 half lives, whichever is longer before any baseline RLS assessments and PLM measurements are obtained.
- •Subject has regular sleep hours between 9 p.m. and 9 a.m.
- •Subjects at risk for pregnancy must have a negative pregnancy test at baseline and be practicing an acceptable form of birth control.
排除标准
- •RLS 2° to other CNS disease or injury. Such disorders include peripheral neuropathy, neurodegenerative disorders, and multiple sclerosis.
- •RLS 2° to Chronic Kidney Disease.
- •Any pain related or sleep related disorders (e.g. sleep apnea) which may confound the outcome measures.
- •History of neuroleptic akathisia.
- •Oral iron use (including multivitamins with iron) after screening.
- •Parenteral iron use within 4 weeks prior to screening.
- •Parenteral iron use > 125 mg per week within 4 to 8 weeks prior to screening.
- •History of > or = to 10 blood transfusions in the past 2 years.
- •Anticipated need for blood transfusion during the study.
- •Known hypersensitivity reaction to any component to FCM.
- •Previously participated in an FCM clinical trial.
- •Chronic or serious active severe infection.
- •Malignancy (other than basal or squamous cell skin cancer or the subject has been cancer free for > 5 years).
- •Active inflammatory arthritis (e.g. rheumatoid arthritis, SLE).
- •Receiving prescription medication for the treatment of bronchospasm.
- •Pregnant or lactating women.
- •Severe peripheral vascular disease with significant skin changes.
- •Seizure disorder currently being treated with medication.
- •Baseline ferritin > 300 ng/mL.
- •Baseline TSAT > or = to 45%.
- •History of hemochromatosis or hemosiderosis or other iron storage disorders.
- •AST or ALT greater than the upper limit of normal.
- •Hemoglobin greater than the upper limit of normal.
- •Calcium or phosphorous outside the normal range.
- •Known positive hepatitis B antigen (HBsAg) or hepatitis C viral antibody (HCV) with evidence of active hepatitis.
- •Known positive HIV-1/HIV-2 antibodies (anti-HIV).
- •Received an investigational drug within 30 days before randomization.
- •Chronic alcohol or drug abuse within the past 6 months.
- •Significant cardiovascular disease, including myocardial infarction within 12 months prior to study inclusion, congestive heart failure NYHA (New York Heart Association) III or IV, or poorly controlled hypertension according to the judgment of the investigator.
- •Any other pre-existing laboratory abnormality, medical condition or disease which in view of the investigator participation in this study may put the subject at risk.
- •Subject unable to comply with study requirements.
研究组 & 干预措施
Intravenous (IV) Iron
Experimental
干预措施: Ferric Carboxymaltose (FCM) (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
International Restless Legs Syndrome (IRLS) Total Score
时间窗: Change from Baseline to Day 28
The scale represents the patients symptoms of RLS. The patient rates his/her symptoms based on 10 questions with a maximum possible score of 40 representing the most severe symptoms while a score of 0 represents no symptoms at all.
次要结局
未报告次要终点
研究者
相似试验
Unknown
1 期
Safety and Explore the Efficacy of Multiple Doses of FURESTEM-AD Inj. for Moderate to Severe Chronic Atopic DermatitisAtopic DermatitisNCT04725136Kang Stem Biotech Co., Ltd.96
已完成
2 期
A Study of Human Monoclonal Antibodies, BRII-196 and BRII-198COVID-19NCT04787211Brii Biosciences Limited48
已完成
2 期
A Study of VAL401 in the Treatment of Patients With Locally Advanced or Metastatic Non-small Cell Lung CancerCarcinoma, Non-Small-Cell LungAdenocarcinomaNCT02875340ValiSeek Limited8
已完成
2 期
Phase II Artesunate Study in Severe MalariaMalariaNCT00522132Medicines for Malaria Venture200
进行中（未招募）
不适用
TRIAL TO ASSESS THE EFFICACY OF LENVATINIB IN METASTATIC NEUROENDOCRINE TUMORS (TALENT STUDY).?EUCTR2015-001467-39-ESGETNE (Grupo Español de Tumores Neuroendocrinos)110