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Also known as Metoclopramide Nasal Spray, Reglan
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 being developed as a nasal spray for diabetic gastroparesis and gastroparesis, conditions marked by delayed gastric emptying. Evoke Pharma is studying it in adults with these gastrointestinal conditions. It is an investigational product in clinical development and has not been established as approved for these uses based on the development information available.
Metoclopramide targets dopamine receptor D2 (DRD2) and serotonin receptors HTR4 and HTR3A. It acts as an antagonist at these targets. This receptor activity underlies its prokinetic and antiemetic effects in the gastrointestinal tract, which are relevant to its study in gastroparesis.
Evoke Pharma, Inc. (ticker: EVOK) is developing metoclopramide nasal spray. The company is the sponsor of the clinical program evaluating this formulation for diabetic gastroparesis and gastroparesis.
Metoclopramide nasal spray is in Phase 3 clinical development. Two Phase 3 trials have been completed, and a Phase 2 trial has also been completed. It remains an investigational therapy and is not approved for marketing based on the development stage reported.
Metoclopramide nasal spray has been studied in completed trials including NCT02025751 (Phase 3, men with diabetic gastroparesis, 53 participants), NCT02025725 (Phase 3, women with diabetic gastroparesis, 205 participants), and NCT00845858 (Phase 2, diabetic patients with gastroparesis, 287 participants). All were conducted in the United States.
Metoclopramide nasal spray is an alternative name for metoclopramide as developed by Evoke Pharma. It refers to the nasal spray formulation of the small molecule metoclopramide, which is being studied for diabetic gastroparesis and gastroparesis.