Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Sacrosidase · 1 trial · 1 indication
The numeric value of the Total Symptom Score (TSS) is derived from the Daily Symptom Questionnaire (DSQ). The DSQ consisted of rating the frequency in the last 24 hours and the severity of 7 symptoms, abdominal bloating, abdominal pain, abdominal cramps, abdominal gas/flatulence, constipation, nausea, and diarrhea. The daily symptom score is calculated by summing the frequency and severity scores for each symptom with a minimum daily score of 0 and a maximum daily score of 98. The TSS is calculated by averaging the combined daily symptom scores during a 7-day period for baseline and 1-week post-intervention during each treatment period and ranges from 0-98, with higher values representing a worse outcome.
| Arm | Type | Description |
|---|---|---|
| Treatment | EXPERIMENTAL | Subjects will be randomized to take active treatment, sacrosidase, 2 mL (17,000 IU) with every meal or snack, administered orally following dilution with 2 to 4 ounces (60 to 120 mL) of water or milk (either cold or at room temperature) during either Treatment Period 1 or Treatment Period 2. The study treatment period is one week. |
| Placebo | PLACEBO_COMPARATOR | Subjects will be randomized to take placebo treatment, sacrosidase placebo, 2 mL (17,000 IU) with every meal or snack, administered orally following dilution with 2 to 4 ounces (60 to 120 mL) of water or milk (either cold or at room temperature) during either Treatment Period 1 or Treatment Period 2. The study treatment period is one week. |
| Name | Type | Description |
|---|---|---|
| Sacrosidase Oral Solution | DRUG | Study drug |
| Placebo | DRUG | Placebo |
Inclusion Criteria: * Ability to comprehend and provide a signed and dated informed consent form * Stated willingness to comply with all study procedures and attend all scheduled clinic visits, and continue participation for the duration of the study * Ability to self-administer oral medication and...
Sacrosidase is an investigational small molecule being developed for the treatment of fructan intolerance, a condition where the body has difficulty digesting fructans, which are carbohydrates found in foods like wheat, onions, and garlic. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
Sacrosidase is being developed by Evoke Pharma, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol EVOK. The company is conducting clinical research to evaluate the drug's safety and efficacy in patients with fructan intolerance.
Sacrosidase is in Phase 2 clinical development. It is an investigational drug and has not yet received regulatory approval. A Phase 2 clinical trial has been completed to assess its effects in subjects with fructan intolerance, but the drug remains in the clinical research stage.
Sacrosidase has been studied in one completed Phase 2 clinical trial with the identifier NCT05703009, titled 'Effects of Sacrosidase and Placebo in Subjects With Fructan Intolerance.' The trial enrolled 25 participants in the United States and was a randomized, double-blind, placebo-controlled study.
Sacrosidase is a distinct investigational drug and is not known to be the same as any other approved or marketed medication. It is being studied specifically for fructan intolerance, and no alternative names have been reported for this compound.