Study to Evaluate Safety & Efficacy of FLX-787-ODT to Treat Fasciculations in Tongue and Appendicular Muscle in Adult Subjects With ALS

Study to Evaluate Safety & Efficacy of FLX-787-ODT to Treat Fasciculations in Tongue and Appendicular Muscle in Adult Subjects With ALS

Quick Info:

Status:
Currently Recruiting
Estimated Enrollment:
15
Phase:
1 & 2
Treatment Type:
Single Group Assignment, no masking
Trial Type:
Drug: FLX-787-ODT
Sponsor:
Flex Pharma
Primary Investigator:
Contact Information:

Enrollment Criteria:

Forced Ventilation

Breathing Ability

Percent lung function (FVC) or (SVC)
not specified
Months/Onset

Months Since Onset

Number of months since first
symptoms of ALS
<5 years
BiPap Allowed

Non-Invasive Ventilation (NIV)

Can PALS use a BiPAP in the trial?
not specified
DPS Allowed

Diaphragm Pacer (DPS)

Can PALS use a DPS in the trial?
not specified
Edaravone Usage

Edaravone Usage

Can a PALS use edaravone (Radicut/Radicava)
while enrolled in the trial?
Unknown

Update Notes:

4/11/2018No significant updates
4/2/2018No significant updates
1/24/2018Recruitment status updated
11/8/2017Trial added

Locations:

Beth Israel Deaconess Medical Center, Boston, 02215

Other Information:

Purpose: 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 tongue and muscle strength, speech, and swallowing are affected, and monitor any side effects that might develop while taking the investigational product. Participants will be assessed before and after taking a single dose of FLX-787-ODT. Approximately 15 people will take part in this study at one center in the United States. Participants will be in the study for a single clinic visit and receive a telephone call 7 days later to monitor for side effects.
Eligibility: 18 Years and older, all genders, not accepting healthy volunteers
Details:
Collaborator(s):
News Articles and Summaries:
ALS Forum:
First Published on Clinicaltrials.gov: 10/26/2017
ClinicalTrials.gov ID: NCT03334786
Trial Protocol as Published on Clinicaltrials.gov:
ClinicalTrials.gov