EUCTR2008-001999-67-ES进行中（未招募）1 期
Estudio aleatorizado, doble ciego, controlado con placebo, de grupos paralelos y de 14 semanas de tratamiento para evaluar la eficacia, seguridad y tolerabilidad de Nerispirdina 50 mg, 100 mg y 200 mg en pacientes con Esclerosis Múltiple___________________________________________________________________A 14-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Nerispirdine 50 mg, 100 mg, and 200 mg in Patients with Multiple Sclerosis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 368
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. Clinically definite MS (McDonald criteria), which includes patients with remitting-relapsing, secondary progressive, progressive-relapsing, or primary progressive MS AND walking disability due to MS (untreated or treated with a stable regimen of a marketed compound for treatment of MS, limited to beta interferons or glatiramer acetate). MS type (relapsing-remitting, secondary progressive, primary progressive, or progressive relapsing) will be determined by the Investigator based on the AAN Practice Guidelines and Tools (http://www.aan.com/go/practice/guidelines) and reference 1 provided in the protocol.
- •2. Signed Informed Consent form
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Methodology-related
- •1. Patient who is able to walk 25 feet in less than 8 seconds or subject who takes more than 45 seconds (for any of the 2 allowed trials) to walk 25 feet with or without an assistive device during the T25-FW assessment at V1-V4 (before randomization). Patients without valid V1, V2, and V4 T25-FW measurements are not eligible for randomization.
- •2. Multiple sclerosis exacerbation or clinical relapse within 6 months prior to the screening visit (V1) or change in regimen or type of MS treatment during the last 3 months, or start of MS disease-modifying therapies within the 3 months prior to screening.
- •3. Age <18 years
- •4. Patients who participated in any previous nerispirdine (HP184) trials
- •5. Patients who were previously exposed to 3,4-diaminopyridine or 4-aminopyridine (4-AP, fampridine, Fampridine-SR)
- •6. Patients with current active psychiatric disorders including but not limited to active psychosis, exacerbation of schizophrenia, bipolar disorder, obsessive-compulsive disorder, major depressive disorder, anxiety disorder, and alcohol or substance abuse or dependence (except nicotine)
- •7. Use of any investigational drug within 30 days or 5 half-lives whichever is longer
- •8. Patient is the Investigator or any Subinvestigator, Research Assistant, Pharmacist, Study Coordinator, other staff or relative thereof directly involved in the conduct of the protocol/study
- •9. Patients who are unable to participate for the entire duration of the study, or in the opinion of the Investigator, are likely to be non-compliant with the obligations inherent in the clinical trial participation
- •10. Any clinically meaningful or unexplained laboratory abnormality(ies); clinically significant or unstable condition(s) or comorbidities; acute or chronically progressive medical or surgical disorder(s) other than MS which may interfere with walking and may affect patient safety (see Appendix L of the protocol)
- •Patients with confirmed neutropenia (neutrophils < 1500/mm3 or according to ethnic group), thrombocytopenia (platelets < 100 000/ mm3), increase in aminotransferases (either ALT [SGPT] or AST [SGOT] >3 ULN and CPK normal) or creatinine clearance < 50 mL/min cannot be randomized (see Appendix L specifying criteria for discontinuation of IP).
- •-Nerispirdine-related based on current knowledge on the compound
- •11. Criteria to reduce reproductive risk:
- •Breastfeeding and pregnant females cannot be included in a clinical study testing nerispirdine. Male subjects who are sexually active with a pregnant female should not participate in the study. Also, patients wishing to breastfeed or parent a child during the course of the study must not participate.
- •Women of childbearing potential (WOCBP) as defined in the protocol or male patients not using an effective contraceptive method as described in the protocol cannot be included in clinical studies testing nerispirdine. Women of childbearing potential, who are unwilling to or unable to be tested for pregnancy at study entry and at each clinic visit, or who experience an unexpected delay of menses cannot participate in the study. The pregnancy test to be used in this study is a serum pregnancy test (?-HCG), and not an urine pregnancy test. This test will be performed at each visit.
- •If, during any nerispirdine study, a female subject becomes pregnant or decides to attempt to become pregnant or if a male subject decides to attempt to father a child, then she or he must stop the study drug immediately. If
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