Different Doses of Naronapride vs. Placebo in Gastroparesis (MOVE-IT)

April 13, 2026 updated by: Dr. Falk Pharma GmbH

Double-blind, Randomised, Placebo-controlled, Dose-finding Phase IIb Trial to Evaluate the Efficacy, Safety, and Tolerability of a 12-week-treatment With Naronapride in Adult Participants With at Least Moderate Idiopathic or Diabetic Gastroparesis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

328

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium
        • University of Leuven
  • United States
    • California
      • Chula Vista, California, United States, 91910
        • Dr Falk Investigational Site
      • Lomita, California, United States, 90717
        • Dr Falk Investigational Site
    • Florida
      • Clearwater, Florida, United States, 33756
        • Dr Falk Investigational Site
      • Doral, Florida, United States, 33126
        • Dr Falk Investigational Site
      • Hollywood, Florida, United States, 33021
        • Dr Falk Investigational Site
      • Maitland, Florida, United States, 32751
        • Dr Falk Investigational Site
      • Miami, Florida, United States, 33144
        • Dr Falk Investigational Site
      • Miami, Florida, United States, 33183
        • Dr Falk Investigational Site
      • Viera, Florida, United States, 32940
        • Dr Falk Investigational Site
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Dr Falk Investigational Site
    • Kentucky
      • Crestview Hills, Kentucky, United States, 41017
        • Dr Falk Investigational Site
    • Louisiana
      • Houma, Louisiana, United States, 70363
        • Dr Falk Investigational Site
      • Marrero, Louisiana, United States, 70072
        • Dr Falk Investigational Site
    • Michigan
      • Flint, Michigan, United States, 48439
        • Dr Falk Investigational Site
      • Flint, Michigan, United States, 48503
        • Dr Falk Investigational Site
    • New York
      • New York, New York, United States, 10033
        • Dr Falk Investigational Site
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • Dr Falk Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19087
        • Dr Falk Investigational Site
    • Tennessee
      • Cordova, Tennessee, United States, 38018
        • Dr Falk Investigational Site
      • Nashville, Tennessee, United States, 37211
        • Dr Falk Investigational Site
    • Texas
      • Harlingen, Texas, United States, 78550
        • Dr Falk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Men and women between ≥18 and ≤75 years of age,
  • Body Mass Index (BMI) ≥16 and <35 kg/m2 ,
  • History of idiopathic or diabetic gastroparesis cardinal symptoms (e.g., nausea, vomiting, early satiety, postprandial fullness, bloating or upper abdominal pain) for ≥3 months,
  • Evidence of delayed gastric emptying by 13C-spirulina gastric emptying breath test (GEBT) for solids with gastric emptying T1/2 ≥ 85.33 minutes (≥ 90th percentile of normative data) during the screening phase,
  • Average weekly total symptom score of the ANMS GCSI-DD ≥2.0 based on the daily symptom scores recorded for at least 5 of 7 consecutive days in the week prior to Baseline,
  • Participants with a type I or type II diabetes mellitus diagnosis must have a controlled diabetes mellitus defined as HbA1c ≤11% under stable antidiabetic medication,
  • Exclusion of any mechanical and/or anatomical obstructions, stenosis, structural diseases, or gastric ulcers by upper gastrointestinal endoscopy during screening phase (previous endoscopic results within 12 months are acceptable, if no relevant changes in patient's disease status occurred since that time),
  • No evidence of intestinal stenosis as determined by an imaging technique (i.e., either abdominal sonography, Magnetic resonance imaging [MRI] or imaging by computed tomography [CT] during screening phase (previous MRI/CT imaging or sonography results within 12 months are acceptable, if no relevant changes occurred in patient's disease status since that time),

Exclusion Criteria:

  • History of major gastrointestinal surgery such as gastric bypass, anti-reflux surgery, gastric per oral endoscopic myotomy (G-POEM), gastrointestinal malignancy, colectomy,
  • Intrapyloric botulinum toxin injection within 12 months,
  • Gastric stimulator implant,
  • Known secondary causes of gastroparesis including but not limited to Parkinson's Disease, cancer, or connective tissue diseases,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo
Experimental: Naronapride 10 mg
Drug: Naronapride
Naronapride is a 5HT-4 agonist
Experimental: Naronapride 20 mg
Drug: Naronapride
Naronapride is a 5HT-4 agonist
Experimental: Naronapride 40 mg
Drug: Naronapride
Naronapride is a 5HT-4 agonist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index - Daily Diary total score from baseline to week 12
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Falk Pharma GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2023

Primary Completion (Actual)

August 12, 2025

Study Completion (Actual)

September 4, 2025

Study Registration Dates

First Submitted

November 3, 2022

First Submitted That Met QC Criteria

November 10, 2022

First Posted (Actual)

November 18, 2022

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NAT-19/GPX

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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