Naronapride for Gastroparesis

(MOVE-IT Trial)

Recruiting at 20 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Dr. Falk Pharma GmbH

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

320 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called Naronapride for gastroparesis, a condition where the stomach empties too slowly, causing symptoms like nausea and bloating. Researchers compare different doses of Naronapride (10, 20, and 40 mg) against a placebo to determine the most effective option. Individuals with gastroparesis symptoms for at least three months, whether due to diabetes or unknown causes, might be suitable for this study. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Naronapride is as safe as a placebo. In earlier studies, researchers tested Naronapride on people with gastroparesis, a condition where the stomach empties slowly. The drug helped the stomach empty faster, which is promising for treating this condition. Importantly, these studies found that people taking Naronapride did not experience more side effects than those taking a placebo. This suggests that Naronapride is generally safe and well-tolerated. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Gastroparesis?

Naronapride is unique because it specifically targets the serotonin 5-HT4 receptors in the gut, which can help stimulate gastric motility. This is different from most current treatments for gastroparesis, like metoclopramide, which often work by increasing muscle contractions in the stomach through a broader mechanism that can lead to more side effects. Researchers are excited about Naronapride because it might offer a more targeted approach with potentially fewer side effects, providing relief for those suffering from this condition. Additionally, Naronapride is being tested in various doses (10 mg, 20 mg, and 40 mg), which could help fine-tune its effectiveness and safety for different patients.

What evidence suggests that Naronapride might be an effective treatment for Gastroparesis?

Research suggests that Naronapride may help treat gastroparesis, a condition where the stomach takes too long to empty. Studies have shown that Naronapride can improve symptoms and help the stomach empty faster. In this trial, participants will receive different doses of Naronapride or a placebo. Patients who took various doses of Naronapride reported fewer symptoms of gastroparesis compared to those who took a placebo. The treatment is being tested in various doses and showed promise in earlier trials. While more research is needed, these early findings suggest that Naronapride could be a helpful option for managing gastroparesis symptoms. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

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

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

I have had symptoms of gastroparesis for 3 months or more.

Exclusion Criteria

Gastric stimulator implant

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

I have had major surgery on my digestive system.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Naronapride
• Placebo

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.

How Is the Trial Designed?

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

Who Is Running the Clinical Trial?

Dr. Falk Pharma GmbH

Lead Sponsor

Trials

46

Recruited

9,400+

Published Research Related to This Trial

In a phase 1 trial with 12 healthy males, the co-administration of itraconazole significantly increased the levels of trazpiroben in the body, indicating that trazpiroben's pharmacokinetics can be affected by other medications.

Trazpiroben showed no clinically relevant safety issues, suggesting it may have a better safety profile compared to other treatments for gastroparesis, like domperidone, especially regarding cardiovascular risks.

NCBI (Pubmed)

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. Chen, C., Zhang, W., Bari, M., et al.[2022]

Metoclopramide is the only FDA-approved medication for diabetic gastroparesis, effectively improving gastric emptying and reducing nausea by acting as a dopamine receptor antagonist, but it has significant side effects including the risk of tardive dyskinesia with prolonged use.

Due to its potential for serious side effects, particularly when used for more than 12 weeks, there is a strong need for new treatments for gastroparesis that offer better safety and efficacy profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metoclopramide for the treatment of diabetic gastroparesis. Shakhatreh, M., Jehangir, A., Malik, Z., et al.[2020]

Metoclopramide is currently the only FDA-approved medication for treating gastroparesis, but it carries a significant risk of side effects, including tardive dyskinesia, which can occur in up to 15% of patients.

This review aims to clarify how metoclopramide works to alleviate gastroparesis symptoms while also assessing its clinical efficacy and the associated risks, particularly focusing on strategies to reduce complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metoclopramide in the treatment of diabetic gastroparesis. Lee, A., Kuo, B.[2022]

Domperidone is a dopamine-2 receptor antagonist that effectively acts as an antiemetic and prokinetic agent, improving stomach and small intestine motor function without causing neurological side effects due to its limited ability to cross the blood-brain barrier.

It has a strong safety profile for long-term oral use and is now available for prescription in the U.S. for treating gastroparesis and chronic nausea and vomiting, making it a valuable option for gastroenterologists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Domperidone: review of pharmacology and clinical applications in gastroenterology. Reddymasu, SC., Soykan, I., McCallum, RW.[2022]

In a study involving 10 patients with diabetes and moderate-to-severe gastroparesis, TZP-101 significantly improved gastric emptying times, reducing solid meal half-emptying by 20% and latency times by 34% compared to placebo.

TZP-101 was well-tolerated with mostly mild and self-limiting adverse events, indicating a favorable safety profile for this ghrelin agonist in treating gastroparesis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ghrelin receptor agonist (TZP-101) accelerates gastric emptying in adults with diabetes and symptomatic gastroparesis. Ejskjaer, N., Vestergaard, ET., Hellström, PM., et al.[2012]

Domperidone is an effective treatment for gastroparesis, showing superior efficacy compared to placebo and other available therapies, despite its controversial status in the US due to safety concerns.

Although there are safety concerns regarding cardiac toxicity associated with domperidone, the evidence on this issue is not convincing, suggesting that its benefits may outweigh the risks for patients with gastrointestinal motility disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Making a case for domperidone in the treatment of gastrointestinal motility disorders. Ahmad, N., Keith-Ferris, J., Gooden, E., et al.[2013]

Aprepitant, a neurokinin-1 receptor antagonist, was successfully used to treat refractory nausea in a 41-year-old female patient with idiopathic gastroparesis, leading to significant symptom relief within 48 hours and improved quality of life over two months.

Despite aprepitant not being approved for gastroparesis-related nausea, the patient experienced no adverse effects and was able to reduce her need for intravenous hydration, suggesting potential cost-effectiveness and warranting further research into its use for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gastroparesis-associated refractory nausea treated with aprepitant. Fahler, J., Wall, GC., Leman, BI.[2018]

In a 4-week trial involving 126 patients with chronic nausea and vomiting due to gastroparesis, aprepitant did not significantly reduce nausea severity compared to placebo, indicating limited efficacy as a primary treatment for this symptom.

However, aprepitant showed significant improvements in secondary outcomes, such as reductions in overall symptom severity and vomiting frequency, suggesting it may still provide some benefits for patients with gastroparesis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aprepitant Has Mixed Effects on Nausea and Reduces Other Symptoms in Patients With Gastroparesis and Related Disorders. Pasricha, PJ., Yates, KP., Sarosiek, I., et al.[2019]

Domperidone is a new anti-nauseant that effectively reduces nausea and vomiting without causing common side effects like extrapyramidal symptoms or adrenolytic effects, making it safer than many existing anti-emetics.

Clinical trials have demonstrated that domperidone not only alleviates nausea but also enhances gastric emptying motility, proving to be an effective treatment for both adults and children suffering from dyspepsia or vomiting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Domperidone, a novel and safe gastrokinetic anti-nauseant for the treatment of dyspepsia and vomiting. Reyntjens, AJ., Niemegeers, CJ., Van Nueten, JM., et al.[2014]

In a study of 34 patients with gastroparesis, prucalopride significantly improved symptoms and quality of life, as measured by the Gastroparesis Cardinal Symptom Index and other assessments, compared to placebo.

Prucalopride also enhanced gastric emptying rates, reducing the gastric half-emptying time from 143 minutes to 98 minutes, indicating its efficacy in treating gastroparesis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prucalopride in Gastroparesis: A Randomized Placebo-Controlled Crossover Study. Carbone, F., Van den Houte, K., Clevers, E., et al.[2020]

Citations

1. drfalkpharma.com drfalkpharma.com/en/newsroom/detail/completion-of-enrollment-of-the-global-phase-2b-study/

Completion of Enrollment of the Global Phase 2b Study This trial compares the effects of three daily doses of naronapride (10 mg, 20 mg, and 40 mg TID) versus placebo over 12 weeks in 320 patients.

2. clinicaltrial.be clinicaltrial.be/en/details/190679?per_page=100&recruiting=1&enrolling_by_invitation=0&active_not_recruiting=0&not_yet_recruiting=0&completed=0&only_recruiting=1&only_eligible=0

Different Doses of Naronapride Vs. Placebo in Gastropares... This is a double-blind, randomized, multicenter, placebo-controlled, comparative phase II dose-finding trial.

3. drfalkpharma.com drfalkpharma.com/en/newsroom/detail/initiation-of-phase-ii-study-of-naronapride-in-patients-with-gastroparesis/

Initiation of Phase II Study of naronapride in patients with ... The primary endpoint of the trial is change from baseline in the signs and symptoms of either idiopathic or diabetic gastroparesis. Several ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05621811?term=NCT05621811&rank=1

Different Doses of Naronapride Vs. Placebo in Gastroparesis In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical ...

5. synapse.patsnap.com synapse.patsnap.com/article/renexxion-and-dr-falk-pharma-expand-phase-2b-move-it-study-of-naronapride-in-gastroparesis-dose-first-us-patient

Renexxion and Dr. Falk Pharma Expand Phase 2b MOVE- ... He pointed out that recent studies have shown that 5-HT4 agonists significantly improve gastroparesis symptoms and gastric emptying time.

6. withpower.com withpower.com/trial/phase-2-gastroparesis-10-2022-ebe78

Naronapride for Gastroparesis (MOVE-IT Trial) 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 ...

7. synapse.patsnap.com synapse.patsnap.com/article/fda-approves-naronapride-ind-for-gastroparesis-treatment-and-us-phase-2b-study-expansion

FDA Approves Naronapride IND for Gastroparesis ... Naronapride, with its demonstrated safety across four Phase 2 trials and its mechanism of action, presents a compelling alternative for the ...

8. clinicaltrials.eu clinicaltrials.eu/inn/naronapride-dihydrochloride-trihydrate/

Naronapride Dihydrochloride Trihydrate Study on the Safety and Effectiveness of Naronapride for Adults with Moderate Idiopathic or Diabetic Gastroparesis. This clinical trial is focused on studying ...