EUCTR2010-023097-40-FR进行中（未招募）不适用
A Phase II, Randomised, Placebo-Controlled Trial of the Safety, Efficacy, Pharmacodynamics of PTX3003 in Patients with Charcot-Marie-Tooth Disease Type 1A - non applicable
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Pharnext
- 入组人数
- 80
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. DNA proven CMT1A
- •2. Muscle weakness in at least foot dorsiflexion (clinical assess-ment)
- •3. Age between 18 and 65 years
- •4. Male or non pregnant, non breastfeeding female
- •5. CMT neuropathy score at screening = 18
- •6. Agrees to perform neurophysiological studies and two cutaneous biopsies (at baseline and end of treatment) for the determination of PMP22 mRNA expression and histology
- •7. Providing signed written informed consent to participate in the study and willing and able to comply with all study procedures and scheduled visits.
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patients with another neurological disease
- •2. Patients using unauthorized concomitant treatments including but not limited to ascorbic acid, opioids, potentially neurotoxic drugs (list provided in appendix 1). Patients who can/agree to stop these medications 4 weeks before randomization can be in-cluded.
- •3. Patients who have participated in another trial of investigational drug within the past 30 days
- •4. Concomitant major systemic disease
- •5. Clinically significant history of unstable medical illness over the last 30 days (unstable angina…)
- •6. History of significant hematologic, kidney, liver disease, or insu-lin-dependent diabetes
- •7. Clinically significant abnormalities on the pre-study laboratory evaluation, physical evaluation, ECG
- •8. ASAT/ALAT and serum creatinin levels above the upper limit of normal (ULN)
- •9. Limited mental capacity or psychiatric disease rendering the subject unable to provide written informed consent or comply with evaluation procedures
- •10. History of recent alcohol or drug abuse or non-adherence with treatment or other experimental protocols
- •11. Female of childbearing potential (apart of patients using ade-quate contraceptive measures), pregnant or breast feeding
- •12. Suspected inability to complete the study follow-up (foreign workers, transient visitors, tourists or any others for whom fol-low-up evaluation is not assured)
- •13. Limb surgery within six months before randomization or planned before completion of the trial
- •14. Known allergy to any of the individual components of PXT3003
- •15. Porphyria (a contra indication to baclofen)
研究者
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