CLINICAL TRIALS PROFILE FOR METOCLOPRAMIDE

All Clinical Trials for METOCLOPRAMIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00120653 ↗	Metoclopramide to Treat Anemia in Patients With Myelodysplastic Syndrome (MDS)	Withdrawn	National Heart, Lung, and Blood Institute (NHLBI)	Phase 2	2005-07-14	This study will determine whether the medication metoclopramide can improve red blood counts in people who have myelodysplastic syndrome (MDS). MDS is thought to affect blood stem cells, which can result in low levels of red blood cells-that is, anemia-as well as low white blood cell and platelet counts. Patients with MDS are at risk for infection, spontaneous bleeding, and possible progression to leukemia, a cancer of bone marrow. Although bone marrow can produce some blood cells, this production can be decreased in patients with MDS. The definitive way to treat MDS is stem cell transplantation, but serious complications and a high risk of death make it unsuitable for patients older than age 60 or those who do not have a matched sibling donor. However, scientists have noted improvement in anemia by using metoclopramide, an inexpensive, commonly used medication that does not have many negative side effects. This study will evaluate the safety and effectiveness of that medicine for patients with MDS. Patients ages 18 to 72 whose MDS would require low-intensity treatment-for example, with growth factor and transfusions-and who are not pregnant or breastfeeding may be eligible for this study. There will be about 60 participants. Screening tests include a complete physical examination and medical history, during which patients will provide a list of current medications or supplements they are taking. There will be a collection of about 4 tablespoons of blood for analysis of blood counts as well as liver and kidney function. Patients may also undergo a magnetic resonance imaging (MRI) scan of their brain, but the procedure is optional. During the MRI, they will lie on a table that will slide into the enclosed tunnel of the scanner. The MRI takes about 20 to 30 minutes, and patients will be asked to lie as still as possible. There will also be a bone marrow biopsy, if patients have not had one done within 4 weeks of the start of this study. Eligible patients will take a 10 mg dose of metoclopramide by mouth, three times a day, for 20 weeks. They will be given a 4-week supply, which will be renewed monthly at each treatment visit. It is essential that patients be seen at NIH during the first, third, and fifth months of the study. Visits made in the meantime, at the second and fourth months, may be done at the office of their doctors who have referred them for the study, or at NIH. During the treatment visits, patients will be asked to update their medical history, health conditions, and use of medications or herbal supplements. There will also be a collection of about 1 tablespoon of blood for laboratory tests. Patients will be asked to make a similar follow-up visit 1 month after they stop taking metoclopramide, so that the response to treatment can be evaluated. The use of metoclopramide may cause some people to feel dizzy, lightheaded, tired, or less alert than they are normally. For the first 24 to 48 hours, patients should be cautious when driving, using machinery, or performing hazardous activities. This medicine will add to the effects of alcohol and other central nervous system depressants-such as medicines for allergies and colds, tranquilizers, and prescription pain relievers. Patients need to check with the research team before taking any of those types of medicines, as well as herbal supplements, while using metoclopramide. This study may or may not have a direct benefit for participants. For some, the drug may improve red blood cell counts and decrease the need for red cell transfusions. Knowledge gained in the study may help people in the future.
NCT00003213 ↗	Drugs to Reduce the Side Effects of Chemotherapy	Completed	Swiss Group for Clinical Cancer Research	Phase 3	1996-05-01	RATIONALE: Antiemetic drugs may help to reduce or prevent nausea and vomiting in patients treated with chemotherapy. It is not known whether receiving dexamethasone with granisetron is more effective than receiving dexamethasone with metoclopramide for reducing the side effects of chemotherapy. PURPOSE: Randomized phase III trial to compare the effectiveness of dexamethasone with either granisetron or metoclopramide in patients treated with chemotherapy.
NCT00008736 ↗	Electrogastrography (EGC) in Premature Infants With Feeding Intolerance	Completed	Children's Hospital of Philadelphia	Phase 2	1969-12-31	Serial EGC measurements in premature infants attempting to correlate EGC measurements with signs of feeding intolerance and response to metoclopramide therapy.
NCT00008736 ↗	Electrogastrography (EGC) in Premature Infants With Feeding Intolerance	Completed	National Center for Research Resources (NCRR)	Phase 2	1969-12-31	Serial EGC measurements in premature infants attempting to correlate EGC measurements with signs of feeding intolerance and response to metoclopramide therapy.

Clinical Trial Conditions for METOCLOPRAMIDE

Condition Name

Condition Name for METOCLOPRAMIDE
Intervention	Trials
Nausea	17
Postoperative Nausea and Vomiting	14
Migraine	14
Vomiting	9

Condition MeSH

Condition MeSH for METOCLOPRAMIDE
Intervention	Trials
Vomiting	51
Nausea	43
Migraine Disorders	32
Postoperative Nausea and Vomiting	29

Clinical Trial Locations for METOCLOPRAMIDE

Trials by Country

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Trials by Country for METOCLOPRAMIDE
Location	Trials
United States	219
Egypt	36
Canada	20
Australia	16
Turkey	12

Trials by US State

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−

Trials by US State for METOCLOPRAMIDE
Location	Trials
New York	28
Pennsylvania	15
Texas	13
Illinois	11
Ohio	10

Clinical Trial Progress for METOCLOPRAMIDE

Clinical Trial Phase

Clinical Trial Phase for METOCLOPRAMIDE
Clinical Trial Phase	Trials
Phase 4	94
Phase 3	36
Phase 2/Phase 3	8

Clinical Trial Status

Clinical Trial Status for METOCLOPRAMIDE
Clinical Trial Phase	Trials
Completed	139
Recruiting	36
Not yet recruiting	31

Clinical Trial Sponsors for METOCLOPRAMIDE

Sponsor Name

Sponsor Name for METOCLOPRAMIDE
Sponsor	Trials
Montefiore Medical Center	13
Assiut University	11
Cairo University	10

Sponsor Type

Sponsor Type for METOCLOPRAMIDE
Sponsor	Trials
Other	316
Industry	36
NIH	8

Metoclopramide: Clinical Trials, Market Analysis, and Projections

Introduction

Metoclopramide, a dopamine-2 (D2) receptor antagonist, has been a staple in the treatment of various gastrointestinal disorders, including diabetic gastroparesis. This article delves into the recent clinical trials, market analysis, and future projections for metoclopramide, particularly focusing on its nasal spray formulation.

Clinical Trials Update

Diabetic Gastroparesis Studies

A significant clinical trial update comes from the Phase 3 study on Metoclopramide Nasal Spray (MNS) for diabetic gastroparesis in women. This US multicenter, randomized, double-blind, parallel group study aimed to determine the safety and efficacy of MNS compared to placebo in reducing symptoms of diabetic gastroparesis[1].

• Participant Demographics: The study enrolled women aged 18-75 years with diabetic gastroparesis and delayed gastric emptying.
• Primary Efficacy Endpoint: The primary endpoint was the change in mean daily Gastroparesis Symptom Assessment total score from baseline to Week 4.
• Results: Although the primary endpoint was not met for all enrolled patients, MNS provided significant relief for women with moderate-to-severe symptoms. Specifically, these patients experienced a significant reduction in nausea and upper abdominal pain for all 4 weeks compared to the placebo group.
• Safety Profile: MNS was well tolerated, with treatment-emergent adverse events being primarily mild to moderate, including headache and abdominal pain.

Other Clinical Uses

Another notable study is the Metoclopramide for Avoiding Pneumonia after Stroke (MAPS-2) trial, which investigates the use of metoclopramide in preventing pneumonia and reducing mortality in patients with dysphagia after an acute stroke. This large multicenter phase III trial is ongoing and aims to assess whether metoclopramide reduces mortality, prevents pneumonia, and improves neurological recovery and long-term outcomes[3].

Market Analysis

Current Market Performance

Evoke Pharma, Inc., the company behind the nasal spray formulation of metoclopramide known as GIMOTI, has reported strong financial results. In the third quarter of 2024, GIMOTI achieved net product sales of $2.7 million, marking a 70% increase year-over-year. This growth is accompanied by a 45% year-over-year increase in prescriber growth and a 52% year-over-year increase in prescription fills[2].

Market Players

The global metoclopramide market involves several key players, including Teva, Sanofi, Astellas, and Evoke Pharma, among others. These companies contribute to the market's dynamics through various formulations of metoclopramide, including oral, injectable, and nasal spray forms[5].

Market Dynamics

The market for metoclopramide is driven by the increasing prevalence of gastrointestinal disorders such as diabetic gastroparesis. The FDA approval of GIMOTI as the only nasal spray formulation for the relief of symptoms associated with acute and recurrent diabetic gastroparesis has significantly boosted its market presence. Real-world data presented at the American College of Gastroenterology (ACG) 2024 conference highlighted that GIMOTI enhanced outcomes for patients on GLP-1 therapy, positioning it as a promising supportive care option[2].

Projections and Future Outlook

Market Growth

Given the strong year-over-year growth metrics, Evoke Pharma is revising its 2024 guidance. The increasing adoption of GIMOTI, coupled with its efficacy in treating diabetic gastroparesis, suggests a positive market trajectory. The global metoclopramide market is expected to grow, driven by the expanding patient population and the preference for more convenient and effective treatment options like nasal sprays[2][5].

Competitive Landscape

The competitive landscape is expected to remain dynamic, with multiple players vying for market share. However, Evoke Pharma's GIMOTI holds a unique position as the only FDA-approved nasal spray formulation for diabetic gastroparesis, which is likely to continue driving its market performance.

Future Clinical Applications

Beyond diabetic gastroparesis, metoclopramide is being explored for other clinical applications, such as preventing pneumonia after stroke. The ongoing MAPS-2 trial could expand the therapeutic uses of metoclopramide, potentially opening up new market opportunities if the trial results are favorable[3].

Safety and Side Effects

General Safety Profile

Metoclopramide is known for its well-documented safety profile, although it can cause side effects such as headache, abdominal pain, and in rare cases, tardive dyskinesia. The nasal spray formulation has shown a similar safety profile to placebo in clinical trials, which is a positive indicator for its continued use[1][4].

Long-Term Use Considerations

It is important to note that metoclopramide should generally not be used for more than 12 weeks due to the risk of tardive dyskinesia, a condition characterized by involuntary, repetitive body movements. This limitation is crucial for long-term treatment strategies and patient management[4].

Key Takeaways

• Clinical Efficacy: Metoclopramide nasal spray (GIMOTI) has shown significant efficacy in reducing symptoms of diabetic gastroparesis, particularly in women with moderate-to-severe symptoms.
• Market Performance: GIMOTI has achieved strong financial results, with a 70% year-over-year increase in net product sales and significant gains in prescriber and prescription fill rates.
• Future Outlook: The market for metoclopramide is projected to grow, driven by increasing adoption and potential new clinical applications.
• Safety Profile: Metoclopramide has a well-documented safety profile, but long-term use should be monitored due to the risk of tardive dyskinesia.

FAQs

What is the primary use of metoclopramide nasal spray (GIMOTI)?

GIMOTI is primarily used for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adults.

What were the key findings of the Phase 3 study on MNS for diabetic gastroparesis?

The study found that MNS provided significant relief for women with moderate-to-severe symptoms, reducing nausea and upper abdominal pain, although it did not meet the primary endpoint for all enrolled patients.

Which company developed and markets GIMOTI?

Evoke Pharma, Inc. developed, commercialized, and markets GIMOTI.

What are the potential new clinical applications of metoclopramide being explored?

Metoclopramide is being explored for preventing pneumonia and reducing mortality in patients with dysphagia after an acute stroke in the MAPS-2 trial.

What are the common side effects of metoclopramide?

Common side effects include headache, abdominal pain, and in rare cases, tardive dyskinesia.

Sources

1. A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study: PubMed, "The aim of this phase 3 study was to further determine the safety and efficacy of MNS compared with placebo in reducing symptoms of diabetic gastroparesis in women."
2. Evoke Pharma, Inc. Reports Third Quarter 2024 Financial Results: Evoke Pharma, "GIMOTI third quarter net product sales of $2.7 million, highest quarterly revenue ever with a 70% increase year-over-year."
3. The Metoclopramide for Avoiding Pneumonia after Stroke (MAPS-2) Trial: NIHR, "To assess whether metoclopramide reduces mortality in patients with dysphagia after stroke."
4. Metoclopramide Nasal Spray (Gimoti) for Diabetic Gastroparesis: JAMA, "The FDA has approved Gimoti (Evoke), a nasal spray formulation of the dopamine-2 (D2) receptor antagonist metoclopramide."
5. Global Metoclopramide Market Research Report 2024: Valuates Reports, "Global Metoclopramide Market Research Report contains Market Size, Market Share, Market Dynamics, Porter's 5 force Analysis, Segmentation, Regional and Country-level Analysis."