Phase
Condition
Peripheral Neuropathy
Neuropathy
Treatment
PXT3003 placebo
PXT3003
Clinical Study ID
Ages 16-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients aged 16 to 65 years (included boundary value), of either sex;
Patients with CMT1A (PMP22 duplication on chromosome 17p11.2) confirmed by genediagnosis; 3.2 < CMTNS-v2 score ≤ 18;
4.Patients are dorsalis pedis flexor weakness at least (clinical evaluation); 5.Ulnar nerve motor nerve conductance velocity > 15 m/s; 6.Subjects participate in clinical trials and sign informed consent voluntarily , and they have the ability to understand as will as abide by research procedures.
Exclusion
Exclusion Criteria:
Being allergic to RS-baclofen, naltrexone HCL, D-sorbitol or any component inpxt3003 excipients or having other serious prior allergic reaction;
Existence contraindications of baclofen, naltrexone or sorbitol, such as porphyria;
Any other associated cause of peripheral neuropathy such as diabetes mellitus (including diabetes history and glycosylated hemoglobin >6.5%)
Subjects with other neurological diseases affecting the evaluation of studytreatment;
Patients with the score of ONLS score is 0;
A history of unstable medical diseases with clinically significant unstable medicaldiseases (unstable angina pectoris, tumor, blood disease, hepatitis or liverfailure, renal failure, etc.) that may cause harm to the subjects participating inthis study in the past 1 year;
Limb surgery had implemented within the first six months of randomization or will beplanned before the completion of the clinical trial;
Hepatic or renal dysfunction:
TBIL>1.5×ULN,ALT>3×ULN,AST>3×ULN;
Cr>1.5×ULN;
Syphilis antibody and HIV antibody positive subjects;
Subjects with tumors indicated by chest radiograph or B-ultrasound;
Subjects with alcohol dependence in recent 3 months;
Females that are of childbearing potential, pregnant, or are breast-feeding;Subjectswho are unable to use appropriate contraceptives during the trial;
Subjects with concomitant treatment 4 weeks before enrollment, including but notlimited to baclofen, naltrexone, sorbitol, opioids, vitamin C, levothyroxine andpotentially neurotoxic drugs (such as amiodarone and chloroquine);
Subjects unable to complete the follow-up of study;
Participated in another clinical trial and used the test drug within the last 30days;
Different subjects from the same family and living in the same residence can onlyinclude one subject, so as to avoid treatment confusion, affect blind treatment andaffect the interpretation of the research results;
Investigators affirm the compliance in a certain subject is poor or there are someother factors that are not suitable to participate in this clinical trial.
Study Design
Study Description
Connect with a study center
Peking University Third Hospital
Beijing,
ChinaSite Not Available
Xuanwu Hospital Capital Medical University
Beijing,
ChinaSite Not Available
The First Bethune Hospital of Jilin University
Changchun,
ChinaSite Not Available
The Third Xiangya Hospital of Central South University
Changsha,
ChinaSite Not Available
The First Affiliated Hospital of Fujian Medical University
Fuzhou,
ChinaSite Not Available
Nanfang Hospital Southern Medical University
Guangzhou,
ChinaSite Not Available
The First Affiliated Hospital,Sun Yat-sen University
Guangzhou,
ChinaSite Not Available
The Affiliated Hospital of Guizhou Medical University
Guiyang,
ChinaSite Not Available
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou,
ChinaSite Not Available
The First Affiliated Hospital of Harbin Medical University
Harbin,
ChinaSite Not Available
The First Affiliated Hospital of Anhui Medical University
Hefei,
ChinaSite Not Available
Inner Mongolia People's Hospital
Hohhot,
ChinaSite Not Available
Qilu Hospital of Shandong University
Jinan,
ChinaSite Not Available
The Second Affiliated Hospital of Nanchang University
Nanchang,
ChinaSite Not Available
The Affiliated Hospital of Nanjing University Medical School
Nanjing,
ChinaSite Not Available
Zhongda Hospital Southeast University
Nanjing,
ChinaSite Not Available
Qilu Hospital of Shandong University(Qingdao)
Qingdao,
ChinaSite Not Available
Shanghai Jiaotong University School of Medicine Ruijin Hospital
Shanghai,
ChinaSite Not Available
The First Hospital of China Medical University
Shenyang,
ChinaSite Not Available
The Second Hospital of Hebei Medical University
Shijiazhuang,
ChinaSite Not Available
The First Affiliated Hospital of Soochow University
Suzhou,
ChinaSite Not Available
Renmin Hospital of Wuhan University(Hubei General Hospital)
Wuhan,
ChinaSite Not Available
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an,
ChinaSite Not Available
Henan Provincial People's Hospital
Zhengzhou,
ChinaSite Not Available
The First Affiliated Hospital of Zhengzhou University
Zhengzhou,
ChinaSite Not Available

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