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
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 |
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
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 |