Status:
TERMINATED
Study to Evaluate Safety & Efficacy of FLX-787-ODT to Treat Fasciculations in Tongue and Appendicular Muscle in Adult Subjects With ALS
Lead Sponsor:
Flex Pharma, Inc.
Conditions:
Amyotrophic Lateral Sclerosis
Fasciculation
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The FLX-787-107 study will determine how well FLX-787-ODT works to reduce fasciculations in patients with Amyotrophic Lateral Sclerosis (ALS). The study will measure how often fasciculations occur, if...
Eligibility Criteria
Inclusion
- Documented diagnosis of ALS diagnosis of less than 5 years.
- Greater than 6 fasciculations per minute noted at least in the tongue by clinical, ultrasound, or EMG evaluation.
- Normal oral cavity exam at screening.
Exclusion
- Presence of clinically significant or unstable condition that would result in an increased risk of study participation or difficulty in interpretation of the study results.
- Tremor or other movement disorder that would interfere with recording.
- 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.
- 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.
- Participated in a clinical study (except natural history studies without administration of an investigational product) within 30 days prior to screening.
- Pregnant, breastfeeding, or planning to become pregnant.
- Blood pressure of ≥160 mmHg systolic and/or ≥100 mmHg diastolic.
- Clinically significant abnormalities in laboratory findings (including screening complete electrolyte panel, complete blood count, liver function tests).
Key Trial Info
Start Date :
April 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 23 2018
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT03334786
Start Date
April 5 2018
End Date
August 23 2018
Last Update
August 29 2018
Active Locations (1)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215