EUCTR2017-001042-10-IT进行中（未招募）1 期
A Phase 2, Randomized, Double-blind, Placebo-controlled, 6-Week, Parallel-design Study of the Efficacy and Safety of VX-150 in Treating Subjects With Pain Caused by Small Fiber Neuropathy - NA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 89
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
- •1. Subject will sign and date an informed consent form (ICF)
- •2. Willing and able to comply with scheduled visits, treatment plan, study restrictions, laboratory tests, contraceptive guidelines, and other study procedures
- •3. Subjects (male and female) will be between the ages of 18 and 80 years, inclusive.
- •4. Body mass index (BMI) = 18.0
- •5. Diagnosis of small fiber neuropathy, as per European Federation Neurological Societies (EFNS)/American Academy of Neurology (AAN)
- •guidelines, with pain for at least 3 months prior to screening
- •6. Reduction below the 5th percentile of sex and age-adjusted normal values in epidermal nerve fiber density on punch skin biopsy at the distal site of the leg performed at or within 6 months of screening
- •7. Presence of sural nerve response
- •8. Average NRS score between =4 and =9 reported in the daily diary on Days -7 through -1
- •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 86
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 28
排除标准
- •1. History in the past 10 years of malignancy except for squamous cell skin cancer, basal cell skin cancer, and Stage 0 cervical carcinoma in situ (all 3 with no recurrence for the last 5 years)
- •2. Exposure to neurotoxic drugs (i.e., chemotherapy) since diagnosis of small fiber neuropathy. Untreated or uncontrolled connective tissue disorders, sarcoidosis, Sjögren's syndrome, amyloidosis, Fabry's disease, celiac disease, Lyme disease, autoimmune disorders (i.e., as assessed by anti-nuclear antibodies, rheumatoid factor, sedimentation rate, and/or lupus anti-coagulant) including myasthenia gravis and Guillain-Barre syndrome, which in the opinion of the investigator makes the subject unsuitable for inclusion in this study.
- •3. A known or clinically suspected infection with human immunodeficiency virus or hepatitis B or C viruses
- •4. Current clinically significant liver or kidney dysfunction
- •5. Current uncontrolled thyroid dysfunction
- •6. Subjects with a diagnosis of diabetes who have any 1 of the following criteria:
- •HbA1c = 11% at screening
- •are not stabilized on oral hypoglycemics and/or subcutaneous insulin or diet, in the opinion of the investigator
- •evidence of ulcers or severe nephropathy resulting from their diabetes
- •advanced retinopathy, defined as greater than State 3 (moderate nonproliferative diabetic retinopathy)15
- •history of a clinical atherosclerotic event, such as myocardial infarction or stroke
- •7. History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s); or history or evidence of abnormal ECGs that in the opinion of the investigator or medical monitor would preclude the subject's participation in the study
- •8. Standard 12-lead ECG demonstrating QTc >450 msec at screening. If QTc exceeds 450 msec, the ECG will be repeated 2 more times, and the average of the 3 QTc values will be used to determine the subject's eligibility.
- •9. Concomitant severe pain conditions (i.e., low back pain, radiculopathy, severe bone and musculoskeletal disorders) which may impair self-assessment of pain due to small fiber neuropathy
- •10. Abnormal laboratory results indicative of any significant medical disease that, in the opinion of the investigator, would preclude the subject's participation in the study
- •11. Other serious, acute, or chronic medical or psychiatric illness that, in the judgment of the investigator, could compromise subject safety, limit
- •the subject's ability to complete the study and/or compromise the objectives of the study
- •12. Female subjects who are pregnant, nursing, or planning to become pregnant during the study or within 90 days after the last study drug dose
- •13. Male subjects with a female partner who is pregnant, nursing, or planning to become pregnant during the study or within 90 days after the last study drug dose
- •14. Use of restricted medication or food within the specified duration before the first dose of study drug
- •15. Alcohol, analgesic/opioid, and/or illicit drug abuse as defined by the American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, in the last 12 months before screening, or a positive test for drugs of abuse at screening
- •A positive drug screen for a known concomitant medication that is not otherwise exclusionary (e.g., benzodiazepines) will not disqualify subjects; however, marijuana and marijuana derivatives will not be allowed
- •16. Subject, or close relative of the subject, is the investigator or a subinvestigator, research assistant, pha
研究者
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