A Study to Assess FLX-787 in Subjects With Motor Neuron Disease Experiencing Muscle Cramps.
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| ClinicalTrials.gov Identifier: NCT03196375 |
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Recruitment Status :
Terminated
(Sponsor)
First Posted : June 22, 2017
Last Update Posted : August 29, 2018
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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) |
| Actual Enrollment : | 54 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Primary Completion Date : | July 27, 2018 |
| Actual Study Completion Date : | July 27, 2018 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Experimental |
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Documented diagnosis of Motor Neuron Disease (MND) [including Amyotrophic Lateral Sclerosis (ALS), Primary Lateral Sclerosis (PLS) or Progressive Muscular Atrophy (PMA)]
- Expected survival > 6 months
- Weekly muscle cramping (defined as: a sustained muscle contraction that's most often painful and lasts seconds to minutes)
Exclusion Criteria:
- Presence of major gastrointestinal disorders, such as inflammatory bowel disease, diverticulitis, active peptic ulcer disease, or significant gastroesophageal reflux disease (i.e., not well-controlled on antacids or proton pump inhibitors), or oral or esophageal lesions/ulcers
- Presence of laryngospasm or significant swallowing problems
- Presence of percutaneous endoscopic gastrostomy, esophagogastroduodenoscopy, or G-tube
- Unable or unwilling to discontinue medications for cramps and/or opiates
- Inability to tolerate a spicy sensation in the mouth or stomach
- Actively using illicit drugs or history of chronic substance abuse within the past year prior to screening, including abuse of alcohol
- Intention to change the current level of tobacco use or use of nicotine-containing products (i.e., new smokers or those actively trying to quit may not enrolled)
- Participated in a clinical study (except natural history studies without administration of an investigational product) within 30 days prior to screening
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 |
| Responsible Party: | Flex Pharma, Inc. |
| ClinicalTrials.gov Identifier: | NCT03196375 |
| Other Study ID Numbers: |
FLX-787-203 |
| First Posted: | June 22, 2017 Key Record Dates |
| Last Update Posted: | August 29, 2018 |
| Last Verified: | August 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Motor Neuron Disease Amyotrophic Lateral Sclerosis Primary Lateral Sclerosis Neurodegenerative Diseases Nervous System Diseases Neuromuscular Diseases Progressive Muscular Atrophy |
Muscle cramps Muscle cramping ALS MND PMA PLS FLX-787 |
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Motor Neuron Disease Amyotrophic Lateral Sclerosis Muscle Cramp Spasm Neurodegenerative Diseases Nervous System Diseases Neuromuscular Diseases Spinal Cord Diseases |
Central Nervous System Diseases TDP-43 Proteinopathies Proteostasis Deficiencies Metabolic Diseases Muscular Diseases Musculoskeletal Diseases Neuromuscular Manifestations Neurologic Manifestations |