A Randomized, Double-Blind, Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of FLX-787-ODT for Treatment of Muscle Cramps in Adult Subjects with Charcot-Marie-Tooth Disease
Flex CMT Muscle Cramps Study
Sponsor: FlexPharma, Inc
Enrolling: Male and Female Patients
Study Length: 56 Days
Clinic Visits: 5
IRB Number: AAAR5182
U.S. Govt. ID: NCT03254199
Contact: Allan Paras: 2123056035 / ap3476@cumc.columbia.edu
Additional Study Information: Moving forward in Charcot-Marie-Tooth disease. A clinical research study assessing the safety and effectiveness of an investigational product in people with Charcot-Marie-Tooth (CMT) disease experiencing muscle cramps is now enrolling. Participation is entirely voluntary. Contacting us does not mean that you are required to take part in this study. If you are interested in taking part in the COMMIT Study, we are looking for men and women who: Are 18 years of age or older Have been diagnosed with CMT Have experienced muscle cramps over the past 4 weeks There are other criteria that you will need to meet to join, which the study team will discuss with you.There will be no charge for any study-related treatment or care. For further information about the COMMIT Study, visit www.commitstudy.com or call the neurological research on 212-305-6035
This study is closed
Investigator
Thomas Brannagan, MD
Do You Qualify?
Estimated number of cramps 5 per week during each of the last 4 weeks prior to screening Yes No
Presence of major gastrointestinal disorders Yes No
Presence of significant swallowing problems Yes No
Inability to tolerate a spicy sensation in the mouth or stomach Yes No
Unable or unwilling to discontinue taking opioids at the time of the screening visit Yes No
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You may be eligible for this study

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For more information, please contact:
Allan Paras
ap3476@cumc.columbia.edu
2123056035