Phase
Condition
Peripheral Neuropathy
Neuropathy
Treatment
CLZ-2002
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subjects aged 18 years or older
Subjects with a proven diagnosis of Charcot-Marie-Tooth disease type 1 at the timeof screening visit
Subjects who have muscle weakness in at least foot dorsiflexion (clinicalassessment) at the time of screening visit
Subjects with a CMT neuropathy score (CMTNS-v2) of 2 or more and 30 or fewer pointsat the time of screening visit
Subjects who can understand and are willing to sign a written informed consentdocument are willing to comply with all study procedures and schedule visits.
Exclusion
Exclusion Criteria:
Subjects who have any other neuromuscular diseases
Subjects who have undergone upper and lower limb bone surgery within six monthsbefore screening visit
Subjects who have concerns about muscle strength measurements due to the previoussurgery
Subjects who have severe active infection including severe/purulent cellulitis atthe injection sites at screening visit
Subjects who have a history of hospitalization due to hypersensitivity toantihistamines or allergy or hypersensitivity to certain substances such as food ordrugs
Subjects who have a history of unstable cardiovascular disease defined by thepresence of myocardial infarction (STEMI or NSTEMI) within 6 months before thescreening or the presence of unstable angina pectoris (in the case of increasedfrequency of symptoms, increased severity, or signs of prolonged symptoms atmoderate activity or rest)
Subjects who have a history of a transient ischemic attack (TIA) or stroke within 6months before screening visit
Subjects who have a positive HIV antibody test, hepatitis B antigen, or hepatitis Cantibody test result
Subjects who have a history of malignant tumors within 5 years before screeningvisit
Subjects who have received systemic steroids (inhaled steroids are allowed),immunotherapy, or cytotoxic therapy within 14 days before screening, or who areexpected to receive such treatment during the study period
Subjects who have participated in other clinical trials within 30 days beforescreening visit
Pregnant and lactating women or women of childbearing potential and men who plan apregnancy or are unwilling to use adequate birth control methods& until 30 daysafter the end of drug administration
Study Design
Study Description
Connect with a study center
Samsung Medical center
Seoul, Gangnam-gu 06351
Korea, Republic ofSite Not Available
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