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Metoclopramide · 3 trials · 5 indications
Change from the Baseline Period to Week 4 of the Treatment Period in the mean daily Gastroparesis Symptom Assessment (GSA) total score for subjects receiving Metoclopramide Nasal Spray 10 mg versus subjects receiving placebo. The GSA minimum value is 0 (no symptoms) and the maximum value is 4 (very severe symptoms). A higher score is a worse outcome.
Change from Baseline to Week 4 of the treatment period in the mGCSI-DD total score in male and female subjects receiving metoclopramide nasal spray versus subjects receiving placebo. The mGCSI-DD is a patient reported outcome measure of gastroparesis symptom severity composed of 4 individual symptoms (listed below) with each symptom graded on a scale from 0 (none) to 5 (very severe). 1. Nausea (feeling sick to your stomach as if you were going to vomit or throw up) 2. Early satiety (not able to finish a normal sized meal) 3. Bloating (feeling like you need to loosen clothes) 4. Upper abdominal pain (above the navel) The mGCSI-DD daily score is a mean of the 4 individual symptom scores. The total score is a mean of the daily scores for the observation period. A mean change (improvement) of \>1 category (for example, moderate to mild or severe to moderate) is considered to be clinically meaningful.
| Arm | Type | Description |
|---|---|---|
| Metoclopramide Nasal Spray | EXPERIMENTAL | Metoclopramide Nasal Spray 10 mg, 30 minutes before meals and at bedtime (QID) for 4 weeks |
| Placebo Nasal Spray | PLACEBO_COMPARATOR | Placebo Nasal Spray 30 minutes before meals and at bedtime (QID) for 4 weeks |
| 10 mg Metoclopramide Nasal Spray | EXPERIMENTAL | Metoclopramide Nasal Spray 10 mg, 30 minutes before meals and at bedtime (QID) for 4 weeks |
| Metoclopramide Nasal Spray 10 mg | ACTIVE_COMPARATOR | - |
| Metoclopramide Nasal Spray 14 mg | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Metoclopramide Nasal Spray | DRUG | One 10 mg spray dose 30 minutes before meals and before bed for 28 days (QID) |
| Placebo Nasal Spray | DRUG | One placebo spray dose 30 minutes before meals and before bed for 28 days (QID) |
| metoclopramide | DRUG | 30 minutes before meals and at bedtime for 4 weeks |
| Placebo | DRUG | 30 minutes before meals and at bedtime |
Inclusion Criteria: * Male subjects between the ages of 18 and 75 years * Willingness and ability to give written informed consent * The ability to read, understand and speak English * Prior diagnosis of Type 1 or Type 2 diabetes * Diagnosis of diabetic gastroparesis with confirmation of delayed ga...
Metoclopramide is used for the treatment of diabetic gastroparesis and gastroparesis, a condition characterized by delayed gastric emptying. It is being developed by Evoke Pharma, Inc. (EVOK) as a nasal spray formulation for this gastrointestinal indication.
Metoclopramide is a small molecule that acts as a dopamine receptor antagonist. It works by blocking dopamine receptors in the gastrointestinal tract, which enhances gastric motility and accelerates gastric emptying, thereby addressing the symptoms of gastroparesis.
Metoclopramide is being developed by Evoke Pharma, Inc., a biopharmaceutical company traded under the ticker symbol EVOK. The company is focused on developing this nasal spray formulation for the treatment of diabetic gastroparesis and gastroparesis.
Metoclopramide is in Phase 3 clinical development. It has completed two Phase 3 trials, one in women and one in men with diabetic gastroparesis, as well as an earlier Phase 2 trial. The drug is investigational and has not been approved by the FDA.
Metoclopramide has completed three clinical trials: NCT00845858, a Phase 2 study in diabetic patients with gastroparesis (287 participants); NCT02025725, a Phase 3 study in women with diabetic gastroparesis (205 participants); and NCT02025751, a Phase 3 study in men with diabetic gastroparesis (53 participants). All trials were completed in the United States.
Metoclopramide is the active ingredient in the nasal spray product being developed by Evoke Pharma. The drug is often referred to by its generic name, metoclopramide, and the company's proprietary formulation is known as Gimoti. Both names refer to the same investigational therapy.