- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04010188
A Registered Cohort Study on Charcot-Marie-Tooth Disease
January 7, 2022 updated by: Ning Wang, MD., PhD.
A Registered Observational Cohort Study of Charcot-Marie-Tooth Disease
The aim of the study is to analyze the natural history data data from Charcot-Marie-Tooth disease and related disorders in China, to assess the clinical, genetic, epigenetic features of patients with Charcot-Marie-Tooth disease, and to optimize clinical management.
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Anticipated)
500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Fuzhou, China
- Recruiting
- First Affiliated Hospital of Fujian Medical University
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Contact:
- Jin He, MD
- Email: hejinfimu@hotmail.com
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Principal Investigator:
- Ning Wang, MD, PhD
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Sub-Investigator:
- Jin He, MD
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
CMT patients who are diagnosed in the First Affiliated Hospital of Fujian Medical University.
Description
Inclusion Criteria:
- Patients with the clinical diagnosis of Charcot-Marie-Tooth disease
- Genetic diagnosis of patients with Charcot-Marie-Tooth disease
- Unrelated healthy controls
Exclusion Criteria:
- Decline to participate.
- Other peripheral neuropathy caused by trauma, immunity and toxicosis.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The change of Charcot-Marie-Tooth Neuropathy Score (CMTNS) during 6 month
Time Frame: Up to 6 months
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Charcot-Marie-Tooth Neuropathy Score (CMTNS) was first proposed and validated by Shy et al (Neurology, 2005).
to provide a reliable measure of impairment in Charcot-Marie-Tooth (CMT).
The CMTNS is composed of 9 items evaluating different functions related to the disease: 5 of impairment ('Sensory Symptoms', 'Pin Sensibility', 'Vibration', 'Strength Arms' and 'Strength Legs'), 2 of activity limitations ('Motor Symptoms Arms' and 'Motor Symptoms Legs') and 2 electrophysiological measures.
Each item is scored from 0 to 4 and the total sum of the item scores provides a global measure of disease severity, with higher scores indicating worsening function.
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Up to 6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 1, 2019
Primary Completion (ANTICIPATED)
December 31, 2039
Study Completion (ANTICIPATED)
December 31, 2049
Study Registration Dates
First Submitted
July 4, 2019
First Submitted That Met QC Criteria
July 4, 2019
First Posted (ACTUAL)
July 8, 2019
Study Record Updates
Last Update Posted (ACTUAL)
January 11, 2022
Last Update Submitted That Met QC Criteria
January 7, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Congenital Abnormalities
- Genetic Diseases, Inborn
- Neuromuscular Diseases
- Stomatognathic Diseases
- Neurodegenerative Diseases
- Peripheral Nervous System Diseases
- Heredodegenerative Disorders, Nervous System
- Nervous System Malformations
- Polyneuropathies
- Tooth Diseases
- Nerve Compression Syndromes
- Charcot-Marie-Tooth Disease
- Hereditary Sensory and Motor Neuropathy
Other Study ID Numbers
- MRCTA,ECFAH of FMU [2019] 192
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Charcot-Marie-Tooth Disease
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Hereditary Neuropathy FoundationRecruitingCharcot-Marie-Tooth Disease | Charcot-Marie-Tooth Disease, Type IA | Charcot-Marie-Tooth Disease Type 2A | Charcot-Marie-Tooth | Charcot-Marie-Tooth Disease, Type IB | Charcot-Marie-Tooth Disease Type 2 | Charcot-Marie-Tooth Disease, Type 2C | Charcot-Marie-Tooth Disease Type 2A2B | Charcot-Marie-Tooth... and other conditionsUnited States
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University College, LondonUniversity of IowaUnknownCharcot-Marie-Tooth Disease, Type IA | Charcot-Marie-Tooth Disease Type 2A | Charcot-Marie-Tooth Disease, Type IB | Charcot-Marie-Tooth Disease, Type XUnited Kingdom
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University Hospital, Clermont-FerrandCompletedCharcot-Marie-Tooth Type 1A NeuropathyFrance
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University Hospital, Clermont-FerrandActive, not recruitingCharcot-Marie-Tooth Type 1A NeuropathyFrance
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Pharnext S.C.A.Premier Research Group plc; Eurofins Optimed; Synteract HCR (Syneos Health); Gr... and other collaboratorsActive, not recruitingCharcot-Marie-Tooth Disease, Type IAUnited States, Belgium, Canada, France, Netherlands, Spain, United Kingdom
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Samsung Medical CenterNot yet recruitingCharcot-Marie-Tooth Disease, Type 1
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University of IowaJohns Hopkins University; University of Colorado, Denver; King's College Hospital... and other collaboratorsRecruitingCharcot-Marie-Tooth Disease, Type Ia (Disorder) | HMSNUnited States, Italy, United Kingdom, Australia
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Tasly GeneNet Pharmaceuticals Co., LtdRecruitingCharcot-Marie-Tooth Type 1AChina
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Nationwide Children's HospitalSuspendedCharcot-Marie-Tooth Neuropathy Type 1AUnited States
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University of IowaChildren's Hospital of Philadelphia; University College London Hospitals; National... and other collaboratorsRecruitingCharcot Marie Tooth DiseaseUnited States, United Kingdom, Australia, Italy