Who is sponsoring NCT03254199?

NCT03254199 is sponsored by Flex Pharma, Inc..

What drugs are being tested in NCT03254199?

Interventions in NCT03254199: FLX-787-ODT (orally disintegrating tablet), Placebo ODT.

What condition does NCT03254199 study?

NCT03254199 studies Charcot-Marie-Tooth Disease.

Is NCT03254199 still recruiting?

NCT03254199 is currently terminated. Last updated 29 August 2018.

Last reviewed 2018-08-29 · How we verify

NCT03254199: COMMIT

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study to Assess the Safety and Effectiveness of FLX-787 in Subjects With Charcot-Marie-Tooth Disease Experiencing Muscle Cramps.

Terminated Phase 2 Last updated 29 August 2018

What this trial tests

Phase 2 trial testing FLX-787-ODT (orally disintegrating tablet) in Charcot-Marie-Tooth Disease in 27 participants. Terminated before completion.

Timeline

16 October 2017

Primary endpoint
27 July 2018

27 July 2018

Quick facts

Lead sponsor	Flex Pharma, Inc.
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	27
Start date	16 October 2017
Primary completion	27 July 2018
Estimated completion	27 July 2018
Sites	20 locations across United States

Drugs / interventions tested

FLX-787-ODT (orally disintegrating tablet) — full drug profile →
Placebo ODT — full drug profile →

Conditions studied

Charcot-Marie-Tooth Disease — all drugs for Charcot-Marie-Tooth Disease →

Sponsor

Flex Pharma, Inc. — full company profile →

Who can join

18 and older, any sex, with Charcot-Marie-Tooth Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Challenges in Treating Charcot-Marie-Tooth Disease and Related Neuropathies: Current Management and Future Perspectives.
Pisciotta C, Saveri P, Pareyson D. · · 2021 · cited 35× · PMID 34827446 · DOI 10.3390/brainsci11111447

Verify or expand the search:

Other trials of FLX-787-ODT (orally disintegrating tablet)

Trials testing the same drug.

NCT03196375 — A Study to Assess FLX-787 in Subjects With Motor Neuron Disease Experiencing Muscle Cramps. · Phase 2 · terminated

Other recruiting trials for Charcot-Marie-Tooth Disease

Currently open trials in the same condition.

NCT06203093 — Charcot-Marie-Tooth Disease (CMT) Biological Sample Collection for IPSC Generation and Biobanking · recruiting
NCT04762758 — Phase III Trial Assessing the Efficacy and Safety of PXT3003 in CMT1A Patients · Phase 3 · active not recruiting
NCT04010188 — A Registered Cohort Study on Charcot-Marie-Tooth Disease · recruiting
NCT05902351 — Natural History Study for Charcot Marie Tooth Disease · recruiting

Other Flex Pharma, Inc. trials

Trials by the same sponsor.

NCT03334786 — Study to Evaluate Safety & Efficacy of FLX-787-ODT to Treat Fasciculations in Tongue and Appendicular Muscle in Adult Su · Phase 1, PHASE2 · terminated
NCT03196375 — A Study to Assess FLX-787 in Subjects With Motor Neuron Disease Experiencing Muscle Cramps. · Phase 2 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03254199 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Flex Pharma, Inc.
Last refreshed: 29 August 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03254199.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing