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Development of Current Formulation has Ceased
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FLX-787-ODT (orally disintegrating tablet) | Experimental | Single dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FLX-787-ODT | Drug | Oral Disintegrating Tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline of Diastolic Blood Pressure in mmHg | Diastolic blood pressure collected before and after treatment | Prior to and within 3 hours following administration of investigational product on the single clinic visit |
| Change from Baseline of Systolic Blood Pressure in mmHg | Systolic blood pressure collected before and after treatment | Prior to and within 3 hours following administration of investigational product on the single clinic visit |
| Change from Baseline in Heart Rate in beats per minute | Heart rate collected before and after treatment | Prior to and within 3 hours following administration of investigational product on the single clinic visit |
| Change from Baseline in Respiration Rate in breaths per minute | Respiration rate collected before and after treatment | Prior to and within 3 hours following administration of investigational product on the single clinic visit |
| Change from Baseline in Body Temperature in degrees Celsius or Fahrenheit | Body temperature collected before and after treatment | Prior to and within 3 hours following administration of investigational product on the single clinic visit |
| Change from Baseline of Oral Cavity Examination | Oral Cavity Examination performed before and after treatment | Prior to and twice within 4 hours following administration of investigational product on the clinic visit |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline of Fasciculation Frequency | Fasciculations over time measured by ultrasound before and after treatment | Prior to and twice within 4 hours following administration of investigational product on the clinic visit |
| Change from Baseline of Fasciculation Frequency |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
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| Incidence of Treatment-Emergent Adverse Events |
Adverse Event Information collected throughout the study |
| Prior to and following administration of investigational product on the clinic visit with AEs followed for 7 days after by telephone contact |
Fasciculations over time measured by EMG before and after treatment |
| Prior to and twice within 4 hours following administration of investigational product on the clinic visit |
| Change from Baseline in Peak Tongue Strength in kPa by Iowa Oral Performance Instrument | Peak Tongue Strength Measurements before and after treatment | Prior to and once within 4 hours following administration of investigational product on the clinic visit |
| Change from Baseline in Speech Assessments | Timed Speech Assessments before and after treatment | Prior to and once within 4 hours following administration of investigational product on the clinic visit |
| Change from Baseline in Swallowing Assessments | Timed Swallowing Assessments before and after treatment | Prior to and once within 4 hours following administration of investigational product on the clinic visit |
| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| D005207 | Fasciculation |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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