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Revised contact information and additional details about the high dose ascorbic acid clinical trials have been made available to us. The following is a summary of the information we have about the trials and who to contact if you would like to be considered for participation:
Purpose of the Study
The purpose of the study is to evaluate whether high doses of ascorbic acid have any effect on Charcot-Marie-Tooth disease type 1A (CMT1A) and whether or not it should be studied further. Ascorbic acid is also known as vitamin C and has been successfully used to treat a mouse model of CMT1A and studied extensively for other purposes. However, it has not yet been used to try to treat people with CMT1A.
Number of Subjects
A total of 120 study participants will be enrolled through 3 participating centers: 48 each at Wayne State University (Detroit, MI) and Johns Hopkins University (Baltimore, MD), and 24 at the University of Rochester (Rochester, NY).
Participant Eligibility*
In order to be included in the trial you must:
- Be between 13 and 70 years of age
- Have CMT1A diagnosed by genetic testing in either yourself or a first or second degree relative (this would include your children, grandchildren, brothers/sisters, nieces/nephews, parents, grandparents, aunts/uncles and half-siblings)
- Make 6 visits over 2 years to the study center (twice at the beginning and then once every 6 months for 2 years)
- Take 8 tablets per day of either vitamin C or a placebo (sugar pill) for 2 years
You will not be eligible to participate in the trial if you:
- Are diabetic or have another condition that may cause a peripheral neuropathy
- Are pregnant or nursing
- Have ever had kidney stones
- Have ever taken the chemotherapy agent vincristine
- Have another serious medical condition
- Have been taking very large doses of Vitamin C for a year or more
- Have another type of CMT
*Note: Although there is no fee for participation, neither is there any compensation. The study will not pay for genetic testing and participants are responsible for transportation to and from the study centers.
Overview of Study Design
If you decide to participate in this study, you will be asked to take eight (8) study drug- or placebo capsules every day for two years. After an initial screening evaluation at the research site, you will return within three weeks for a baseline visit and then every six months for two years to participate in study visits.
This is a double blind, placebo-controlled trial. That means you will be randomly assigned into one of two groups. One group—80 percent of all participants—will receive the ascorbic acid, and the other group—the remaining 20 percent—will receive the placebo. Neither you nor your study doctor will be told which group you are in. At the end of your participation in the study, you will be asked to guess whether you were taking the ascorbic acid or the placebo. At the end of the trial, when all volunteers have completed the study, you will be told which group you were in.
Contact Information
If you meet the criteria outlined above and are interested in participating in the study, please use the information below to contact the study center nearest you:
Wayne State University – Detroit MI
Principal Investigator: Richard Lewis, MD
Site Principal Investigator: Michael Shy, MD
Contact Person: Lisa Rowe
Phone: 313.577.1689
Email: lrowe@med.wayne.edu
University of Rochester – Rochester NY
Site Principal Investigator: David Herrmann, MD
Contact Person: Patty Smith
Phone: 585.275.0581
Johns Hopkins University – Baltimore MD
Site Principal Investigator: Ahmet Hoke, MD
Contact Person: Lora Clawson
Phone: 410.614.4346
Email: lclawson@jhmi.edu
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