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TerminatedNCT03334786Updated Aug 29, 2018

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

A Phase 1/2 interventional study of FLX-787-ODT in Amyotrophic Lateral Sclerosis and Fasciculation, sponsored by Flex Pharma, Inc.. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-29.

Sponsored by Flex Pharma, Inc. · Phase 1/2, Interventional, and Treatment

Why this study was terminated
Development of Current Formulation has Ceased

From the registry’s dates

  • Primary completion was Aug 2018, 8 years 2 months ago, and no results have been posted to the registry.
Phase
Phase 1/2
Study type
Interventional
Enrollment
3
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Amyotrophic Lateral Sclerosis
  • Fasciculation

Keywords

  • ALS
  • Amyotrophic Lateral Sclerosis
  • Fasciculation
  • FLX-787
03

In context

Amyotrophic Lateral Sclerosis

978 studies on the registry are indexed under Amyotrophic Lateral Sclerosis; 277 are open to participants now.

This study's enrollment of 3 is below the median of 38 across 662 interventional studies indexed under Amyotrophic Lateral Sclerosis.

Browse Amyotrophic Lateral Sclerosis studies →

Lead sponsor

Flex Pharma, Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 criteria

Exclusion Criteria:

  • Presence of 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 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).
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
3 participants (actual)

Study arms

  • Experimental
    FLX-787-ODT (orally disintegrating tablet)

    Single dose

    Drug: FLX-787-ODT

Interventions

  • DrugFLX-787-ODT

    Oral Disintegrating Tablet

06

What researchers measure

Primary outcomes

  1. Change from Baseline of Diastolic Blood Pressure in mmHg

    Diastolic blood pressure collected before and after treatment

    Time frame: Prior to and within 3 hours following administration of investigational product on the single clinic visit

  2. Change from Baseline of Systolic Blood Pressure in mmHg

    Systolic blood pressure collected before and after treatment

    Time frame: Prior to and within 3 hours following administration of investigational product on the single clinic visit

  3. Change from Baseline in Heart Rate in beats per minute

    Heart rate collected before and after treatment

    Time frame: Prior to and within 3 hours following administration of investigational product on the single clinic visit

  4. Change from Baseline in Respiration Rate in breaths per minute

    Respiration rate collected before and after treatment

    Time frame: Prior to and within 3 hours following administration of investigational product on the single clinic visit

  5. Change from Baseline in Body Temperature in degrees Celsius or Fahrenheit

    Body temperature collected before and after treatment

    Time frame: Prior to and within 3 hours following administration of investigational product on the single clinic visit

  6. Change from Baseline of Oral Cavity Examination

    Oral Cavity Examination performed before and after treatment

    Time frame: Prior to and twice within 4 hours following administration of investigational product on the clinic visit

  7. Incidence of Treatment-Emergent Adverse Events

    Adverse Event Information collected throughout the study

    Time frame: Prior to and following administration of investigational product on the clinic visit with AEs followed for 7 days after by telephone contact

Secondary outcomes

  1. Change from Baseline of Fasciculation Frequency

    Fasciculations over time measured by ultrasound before and after treatment

    Time frame: Prior to and twice within 4 hours following administration of investigational product on the clinic visit

  2. Change from Baseline of Fasciculation Frequency

    Fasciculations over time measured by EMG before and after treatment

    Time frame: Prior to and twice within 4 hours following administration of investigational product on the clinic visit

  3. Change from Baseline in Peak Tongue Strength in kPa by Iowa Oral Performance Instrument

    Peak Tongue Strength Measurements before and after treatment

    Time frame: Prior to and once within 4 hours following administration of investigational product on the clinic visit

  4. Change from Baseline in Speech Assessments

    Timed Speech Assessments before and after treatment

    Time frame: Prior to and once within 4 hours following administration of investigational product on the clinic visit

  5. Change from Baseline in Swallowing Assessments

    Timed Swallowing Assessments before and after treatment

    Time frame: Prior to and once within 4 hours following administration of investigational product on the clinic visit

07

Study locations

1 site
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts 02215, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2018 to primary completion in Aug 2018, 4 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 26, 2017
First posted
Nov 7, 2017
StartActual
Apr 5, 2018
Primary completionActual
Aug 23, 2018
CompletionActual
Aug 23, 2018
Last update
Aug 29, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 29, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03334786
Lead sponsor
Flex Pharma, Inc.
Responsible party
Sponsor
First posted
Nov 7, 2017
Start date
Apr 5, 2018
Primary completion
Aug 23, 2018
Completion
Aug 23, 2018
Last update
Aug 29, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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Flex Pharma, Inc.

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