Status:
WITHDRAWN
Study to Evaluate the Safety & Efficacy of FLX-787-ODT to Treat Fasciculations in Tongue and Upper or Lower Extremity Muscles Most Affected in 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-787-106 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, an...
Eligibility Criteria
Inclusion
- Documented diagnosis of ALS diagnosis of less than 3 years.
- Expected survival \> 6 months
- Frequent fasciculations noted during clinical examination of any single muscle (\>6 visible fasciculations per minute) observed in Part I
- Normal oral cavity exam at screening
- Proficient in English
- Male subjects will either be surgically sterile or agree to use a medically acceptable method of contraception during sexual contact with females of childbearing potential, and will refrain from sperm donation for 45 days following the study
- Male subjects will either be surgically sterile or agree to use a medically acceptable method of contraception during sexual contact with females of childbearing potential, and will refrain from sperm donation for 45 days following the study
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
- Inability to lie flat
- 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
- 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 :
November 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03338114
Start Date
November 1 2017
End Date
August 1 2018
Last Update
January 23 2018
Active Locations (1)
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1
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157