Viewing Study NCT00484510



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Last Modification Date: 2024-10-26 @ 9:33 AM
Study NCT ID: NCT00484510
Status: COMPLETED
Last Update Posted: 2013-03-06
First Post: 2007-06-08

Brief Title: High Dose Ascorbic Acid Treatment of CMT1A
Sponsor: Wayne State University
Organization: Wayne State University

Study Overview

Official Title: A Randomized Placebo-controlled Double Masked 120 Subject Futility Design Clinical Trial of Ascorbic Acid Treatment of Charcot Marie Tooth Disease Type 1A
Status: COMPLETED
Status Verified Date: 2013-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This study will look at the impact of ascorbic acid Vitamin C on the progression of disease in people with CMT1A as compared to volunteers receiving a placebo This study will assess whether is it futile to proceed with a larger longer-term placebo-controlled study
Detailed Description: Charcot Marie Tooth disease CMT or inherited peripheral neuropathies are among the most frequent heritable disorders affecting approximately 1 in 2500 people The most frequent genetic form of CMT is CMT1A CMT1A is caused by a 14 Mb duplication within chromosome 17p112 in the region containing the PMP22 gene Most subjects with CMT1A have a typical phenotype characterized by onset in childhood or early adulthood distal weakness sensory loss foot deformities and absent reflexes How increased expression of PMP22 causes these disabilities is unknown but is currently being investigated in both animal and tissue culture systems In this study researchers will evaluate whether ascorbic acid Vitamin C administered orally slows clinical progression of CMT1A and affects the PMP22 mRNA levels of myelinated peripheral nerve fibers obtained from biopsies of glabrous skin

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
MDA4193 None None None