EUCTR2013-003016-45-NL进行中（未招募）不适用
A double blind, placebo controlled Phase 2 dose ranging study of the effects of ARA 290 on corneal nerve fiber density and neuropathic symptoms of patients with sarcoidosis - DOSARA
Araim Pharmaceuticals0 个研究点目标入组 64 人开始时间: 2013年8月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 64
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Established diagnosis of sarcoidosis with both of the following two criteria:
- •1) Score of of 4 or greater on Brief Pain Inventory average pain” questions (BPI; 0 (least discomfort)-10 (worst discomfort))
- •2) Discomfort defined as distal pain/discomfort plus one of the following: 1) dysesthesia, 2) burning/painful feet worsening at night, or 3) intolerance of sheets or clothes touching the legs or feet
- •AND either of the following two criteria
- •1) Corneal nerve fiber density reduced compared to normal (i.e., greater than 1 standard deviation less than the mean of a normative population)
- •2) A previous skin biopsy (obtained within the prior 2 years) showing a reduced intraepidermal nerve fiber density ((i.e., greater than 1 standard deviation less than the mean of a normal age and gender relevant population)
- •Be able to read and understand the written consent form, complete study-related procedures, and communicate with the study staff
- •Be willing to comply with study restrictions
- •Be willing to check in with the study center via the telephone
- •Between 18 and 70 years of age (inclusive)
- •Body Mass Index (BMI) < 40 kg/m2 (inclusive)
- •If female of childbearing potential, a negative urine pregnancy test at screening and acceptable contraception will be maintained during the screening and dosing period and 1 month beyond. Acceptable contraception consists of hormonal methods such as oral, implantable, injectable, or transdermal contraceptives for a minimum of 1 full cycle (based on the subject’s usual menstrual cycle period) before study entry, intrauterine device (IUD), or double barrier method (condoms, sponge, diaphragm, or vaginal ring with spermicidal jellies or cream).
- •Able to complete self-administered questionnaires (RAND-36, SFNSL, BPI, COMPASS-31, NPSI)
- •Refrigerator and freezer at home for storage of study medication.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 64
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 64
排除标准
- •Medical history of clinically relevant physical and mental health condition other than conditions related to sarcoidosis, as judged by the investigator
- •Clinically relevant abnormal laboratory results, vital signs, or physical findings other than conditions related to sarcoidosis or could interfere with conduct of 6-minute walk assessment (as judged by the investigator)
- •Other medical conditions known to be associated with small nerve fiber loss, except for diabetes in good control (as judged by the investigator)
- •Known clinically relevant abnormalities in ECG (as judged by the investigator)
- •Illicit drug abuse or excessive alcohol consumption (as judged by the investigator)
- •History of serious malignancy within the last 5 years other than a basal cell or squamous cell carcinoma that has been removed.
- •History of severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food that could compromise the safety of the patient
- •History of severe reaction in the past to Candida or Mumps antigens
- •Anti-TNF therapy or other biological anti-inflammatory agents administered within the 6 months prior to screening.
- •Use of erythropoiesis stimulating agents within the two months prior to screening or during the trial
- •Participation in an investigational drug trial in the 3 months prior to administration of the initial dose of study drug or more than 4 times in the calendar year preceding study enrollment
- •Inadequate venous accessibility as judged by study personnel
- •Inability or unwillingness to self-administer ARA 290 via subcutaneous injections (or not have access to home health care for assistance in administration, if needed)
- •If female, pregnant or breast-feeding
- •Any other condition that in the opinion of the investigator would complicate or compromise the study, or the well-being of the subject
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