Naronapride for Gastroparesis

(MOVE-IT Trial)

Recruiting in Palo Alto (17 mi)

+20 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Dr. Falk Pharma GmbH

Disqualifiers: Gastrointestinal surgery, Botulinum injection, Gastric stimulator, others

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This is a double-blind, randomized, multicenter, placebo-controlled, comparative phase II dose-finding trial. The trial will be conducted with four treatment groups in the form of a parallel group comparison and will serve to compare oral treatment with daily doses of 10, 20, or 40 mg Naronapride vs. placebo for the treatment of patients with Gastroparesis.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you have diabetes, you must have controlled diabetes with stable antidiabetic medication.

What data supports the idea that the drug Naronapride for Gastroparesis is an effective treatment?

The available research does not provide specific data on the effectiveness of Naronapride for Gastroparesis. Instead, it discusses other treatments like domperidone and prucalopride. Domperidone has been used successfully for gastroparesis, showing better results than a placebo, but it has safety concerns. Prucalopride has been shown to improve the rate at which the stomach empties, which can help with gastroparesis symptoms. However, there is no direct information on Naronapride's effectiveness in the provided research. ^{1 2 3 4 5}

What safety data exists for Naronapride in treating gastroparesis?

The provided research does not contain specific safety data for Naronapride (also known as ATI-7505) in the treatment of gastroparesis. The articles focus on other treatments like domperidone and metoclopramide, discussing their safety profiles and side effects. To find safety data for Naronapride, one would need to look for clinical trials or studies specifically evaluating Naronapride or ATI-7505. ^{3 5 6 7 8}

Is the drug Naronapride a promising treatment for gastroparesis?

Naronapride, also known as ATI-7505, is considered a promising drug for gastroparesis because it offers hope for better treatment options. Current treatments like metoclopramide have limitations and side effects, so new drugs like Naronapride are eagerly anticipated for their potential to improve symptoms and safety for patients. ^{1 2 8 9 10}

Eligibility Criteria

Adults aged 18-75 with gastroparesis, confirmed by a breath test showing delayed gastric emptying. They must have had symptoms like nausea or bloating for at least 3 months and have a BMI between 16 and 35. People with diabetes can join if their condition is stable (HbA1c ≤11%). Those with any mechanical blockages in the stomach or previous surgeries that could affect results are not eligible.

Inclusion Criteria

I am between 18 and 75 years old.

Body Mass Index (BMI) ≥16 and <35 kg/m2

Evidence of delayed gastric emptying by 13C-spirulina gastric emptying breath test (GEBT) for solids with gastric emptying T1/2 ≥ 85.33 minutes during the screening phase

Exclusion Criteria

I have not had a botulinum toxin injection in my pylorus in the last year.

Gastric stimulator implant

I have had major surgery on my digestive system.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily doses of 10, 20, or 40 mg Naronapride or placebo for 12 weeks

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Naronapride (5-HT4 Receptor Agonist)
• Placebo (Other)

Trial Overview This study tests different doses of Naronapride (10, 20, or 40 mg) against a placebo to see which works best for gastroparesis. Participants will be randomly assigned to one of these four groups without knowing which one they're in—a process known as double-blind.

Participant Groups

Group I: Naronapride 40 mg Experimental Treatment 1 Intervention

Group II: Naronapride 20 mg Experimental Treatment 1 Intervention

Group III: Naronapride 10 mg Experimental Treatment 1 Intervention

Group IV: Placebo Placebo Group 1 Intervention

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Dr Falk Investigational Site Lomita, CA

Dr Falk Investigational Site Clearwater, FL

Dr Falk Investigational Site Maitland, FL

Dr Falk Investigational Site Houma, LA

More Trial Locations

Who Is Running the Clinical Trial?

Dr. Falk Pharma GmbH Lead Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

Gastroparesis-associated refractory nausea treated with aprepitant. [2018] To report a case of refractory nausea in a patient with idiopathic gastroparesis successfully treated with aprepitant.

2. New Zealand pubmed.ncbi.nlm.nih.gov

Evaluation of the Pharmacokinetics of Trazpiroben (TAK-906), a Peripherally Selective D2/D3 Dopamine Receptor Antagonist, in the Presence and Absence of Itraconazole, a Potent CYP 3A4 Inhibitor. [2022] Label="PURPOSE" NlmCategory="OBJECTIVE">Treatment options for gastroparesis, such as metoclopramide and domperidone, are limited because of safety concerns, which may be exacerbated in the presence of inhibitors of drug metabolism. This study evaluated the effect of itraconazole on the pharmacokinetics, safety, and tolerability of trazpiroben (previously TAK-906), a novel, peripherally selective D2/D3 dopamine receptor antagonist.

3. England pubmed.ncbi.nlm.nih.gov

Making a case for domperidone in the treatment of gastrointestinal motility disorders. [2013] There are very few treatment options currently available for patients with gastrointestinal motility disorders, especially patients with gastroparesis. Domperidone, a peripheral dopamine receptor antagonist, has been successfully used for decades in the US and marketed in many countries for the treatment of gastroparesis. Its use, however, has recently become controversial owing to safety concerns, and it has never been approved for marketing by the FDA. During the 1990s, domperidone was available to US gastroenterologists under a compassionate-use program by Janssen Pharmaceutica, as the manufacturer worked towards, and fell short of, full US market approval. Medical studies, trials and case reports demonstrate the superior efficacy of domperidone when compared with placebo and other pharmaceutical therapies available. Data on the cardiac toxicity associated with oral use of domperidone fail to be convincing.

4. United States pubmed.ncbi.nlm.nih.gov

Prucalopride in Gastroparesis: A Randomized Placebo-Controlled Crossover Study. [2020] Prokinetics are considered the preferred treatment option for gastroparesis, but evidence of their efficacy is scarce. Prucalopride, a selective 5-hydroxytryptamine 4 receptor agonist used in the treatment of constipation, is able to enhance the gastric emptying rate. In a double-blind, randomized, placebo-controlled crossover study, we evaluated the efficacy of prucalopride to improve the gastric emptying rate and symptoms in patients with gastroparesis.

5. United States pubmed.ncbi.nlm.nih.gov

Domperidone: review of pharmacology and clinical applications in gastroenterology. [2022] Domperidone is a dopamine-2 receptor antagonist. It acts as an antiemetic and a prokinetic agent through its effects on the chemoreceptor trigger zone and motor function of the stomach and small intestine. Unlike metoclopramide, it does not cause any adverse neurological symptoms as it has minimal penetration through the blood-brain barrier. It thus provides an excellent safety profile for long-term administration orally in the recommended doses. Domperidone is widely used in many countries and can now be officially prescribed to patients in the United States by an investigational new drug application for the treatment of gastroparesis and any condition causing chronic nausea and vomiting. In view of this additional clinical exposure of domperidone to a new generation of gastroenterologists and other specialists, the purpose of this timely review is to revisit the pharmacology, clinical application, and safety profile of this beneficial medication.

6. England pubmed.ncbi.nlm.nih.gov

Metoclopramide in the treatment of diabetic gastroparesis. [2022] Gastroparesis is a chronic disorder that affects a significant subset of the population. Diabetes mellitus is a risk factor for the development of gastroparesis. Currently, metoclopramide is the only US FDA-approved medication for the treatment of gastroparesis. However, the FDA recently placed a black-box warning on metoclopramide because of the risk of related side effects, including tardive dyskinesia, the incidence of which has been cited to be as high as 15% in the literature. This review will investigate the mechanisms by which metoclopramide improves the symptoms of gastroparesis and will focus on the evidence of clinical efficacy supporting metoclopramide use in gastroparesis. Finally, we seek to document the true complication risk from metoclopramide, especially tardive dyskinesia, by reviewing the available evidence in the literature. Potential strategies to mitigate the risk of complications from metoclopramide will also be discussed.

7. Germany pubmed.ncbi.nlm.nih.gov

Domperidone, a novel and safe gastrokinetic anti-nauseant for the treatment of dyspepsia and vomiting. [2014] The new potent anti-nauseant 5-chloro-1-(1p[3-(2,3-dihydro-2-oxo-1H-benzimidazol-1-yl)-propyl]-4-piperidinyl)-1.3-dihydro-2H-benzimidazol-2-one (domperidone), which in contrast to available anti-emetics does not provoke extrapyramidal or adrenolytic adverse effects, also enhances gastric emptying motility. Controlled clinical trials have confirmed its prokinetic effects on the stomach and its lack of side-effects, even at high doses. This anti-nauseant appears to be a safe and effective treatment for patients, both adults and children, with dyspepsia or vomiting.

8. England pubmed.ncbi.nlm.nih.gov

Metoclopramide for the treatment of diabetic gastroparesis. [2020] Introduction: Gastroparesis is a chronic disorder of the stomach characterized by delayed gastric emptying without mechanical obstruction. Diabetes is the most commonly known cause of gastroparesis. Management of diabetic gastroparesis involves lifestyle modifications, glycemic control, pharmacological drugs, and for refractory cases surgical treatments. Metoclopramide remains the only drug approved by the Food and Drug Administration for diabetic gastroparesis. The aim of this article is to provide a concise review of the pharmacology, clinical efficacy and tolerability of metoclopramide. Areas covered: We searched PubMed using the key words 'metoclopramide', 'diabetic gastroparesis', and 'gastric emptying'. The relevant articles and their bibliography were reviewed. Metoclopramide acts on several different receptors; primarily as a dopamine receptor antagonist, both peripherally improving gastric emptying, and centrally resulting in an anti-emetic effect. Metoclopramide side effects, mostly related to its ability to cross the blood-brain barrier, include drowsiness, restlessness, hyperprolactinemia, and tardive dyskinesia (TD), a movement disorder that may be irreversible. Expert opinion: Metoclopramide carries a black box warning for use &gt;12&#160;weeks due to the risk of TD. However, gastroparesis patients experience chronic symptoms often requiring prolonged treatments. Physicians and patients look forward to FDA approval of new agents for gastroparesis with better efficacy and safety profile.

9. England pubmed.ncbi.nlm.nih.gov

Ghrelin receptor agonist (TZP-101) accelerates gastric emptying in adults with diabetes and symptomatic gastroparesis. [2012] TZP-101 is a synthetic, selective ghrelin agonist in development for gastroparesis.

10. United States pubmed.ncbi.nlm.nih.gov

Aprepitant Has Mixed Effects on Nausea and Reduces Other Symptoms in Patients With Gastroparesis and Related Disorders. [2019] There are few effective treatments for nausea and other symptoms in patients with gastroparesis and related syndromes. We performed a randomized trial of the ability of the neurokinin-1 receptor antagonist aprepitant to reduce symptoms in patients with chronic nausea and vomiting caused by gastroparesis or gastroparesis-like syndrome.