A Study to Assess FLX-787 in Subjects With Motor Neuron Disease Experiencing Muscle Cramps.
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|ClinicalTrials.gov Identifier: NCT03196375|
Recruitment Status : Active, not recruiting
First Posted : June 22, 2017
Last Update Posted : June 14, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Motor Neuron Disease||Drug: FLX-787-ODT (orally disintegrating tablet) Drug: Placebo ODT||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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 Motor Neuron Disease|
|Actual Study Start Date :||July 28, 2017|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2018|
Drug: FLX-787-ODT (orally disintegrating tablet)
FLX-787-ODT taken three times daily for 28 days
|Placebo Comparator: Placebo Comparator||
Drug: Placebo ODT
Placebo ODT taken three times daily for 28 days
- Cramp frequency [ Time Frame: 28 days ]Cramp frequency measured over the 28-day treatment period
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03196375
Show 35 Study Locations
|Principal Investigator:||Bjorn Oskarsson, MD||Mayo Clinic Jacksonville Florida|