Who is sponsoring NCT03196375?

NCT03196375 is sponsored by Flex Pharma, Inc..

What drugs are being tested in NCT03196375?

Interventions in NCT03196375: FLX-787-ODT (orally disintegrating tablet), Placebo ODT.

What condition does NCT03196375 study?

NCT03196375 studies Motor Neuron Disease.

Is NCT03196375 still recruiting?

NCT03196375 is currently terminated. Last updated 29 August 2018.

Last reviewed 2018-08-29 · How we verify

NCT03196375

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

A Study to Assess FLX-787 in Subjects With Motor Neuron 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 Motor Neuron Disease in 54 participants. Terminated before completion.

Timeline

28 July 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	54
Start date	28 July 2017
Primary completion	27 July 2018
Estimated completion	27 July 2018
Sites	35 locations across United States

Drugs / interventions tested

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

Conditions studied

Motor Neuron Disease — all drugs for Motor Neuron Disease →

Sponsor

Flex Pharma, Inc. — full company profile →

Who can join

18 and older, any sex, with Motor Neuron Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The COMMEND Study will assess the safety and effectiveness of FLX-787 in men and women with Motor Neuron Disease \[including Amyotrophic Lateral Sclerosis (ALS), Primary Lateral Sclerosis (PLS) or Progressive Muscular Atrophy (PMA)\] 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 approximately 30 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

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

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

Trials testing the same drug.

NCT03254199 — A Study to Assess the Safety and Effectiveness of FLX-787 in Subjects With Charcot-Marie-Tooth Disease Experiencing Musc · Phase 2 · terminated

Other recruiting trials for Motor Neuron Disease

Currently open trials in the same condition.

NCT07204977 — Acamprosate in C9orf72 Hexanucleotide Repeat Expansion Amyotrophic Lateral Sclerosis (ACALS) · Phase 1 · active not recruiting
NCT06566651 — Emotion Processing Among Patients With ALS · recruiting
NCT05744310 — Effects of Long Term Ventilation Support on the Quality of Life of ALS Patients and Their Families · NA · recruiting
NCT06318598 — Biomarker-driven Phenotypic Dissection of Amyotrophic Lateral Sclerosis · recruiting
NCT06318585 — Creation of a Clinical Database for the Study of Phenotypic Variability in Motor Neuron Diseases · 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
NCT03254199 — A Study to Assess the Safety and Effectiveness of FLX-787 in Subjects With Charcot-Marie-Tooth Disease Experiencing Musc · 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 NCT03196375 (US National Library of Medicine, public domain)
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/NCT03196375.

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