Trials / Terminated
TerminatedNCT03254199
A Study to Assess the Safety and Effectiveness of FLX-787 in Subjects With Charcot-Marie-Tooth Disease Experiencing Muscle Cramps.
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
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 27 (actual)
- Sponsor
- Flex Pharma, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The COMMIT Study will assess the safety and effectiveness of FLX-787 in men and women with Charcot-Marie-Tooth disease (CMT) experiencing muscle cramps. Participants will be asked to take two study products during the course of the study. One of these study products will be a placebo. Approximately 120 participants in 20 study centers across the United States are expected to take part. Participants will be in the study for approximately 3 months and visit the study clinic 3 times.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | FLX-787-ODT (orally disintegrating tablet) | FLX-787-ODT taken three times daily for 28 days |
| DRUG | Placebo ODT | Placebo ODT taken three times daily for 28 days |
Timeline
- Start date
- 2017-10-16
- Primary completion
- 2018-07-27
- Completion
- 2018-07-27
- First posted
- 2017-08-18
- Last updated
- 2018-08-29
Locations
20 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03254199. Inclusion in this directory is not an endorsement.