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

• ClinicalTrials.gov Identifier: NCT05621811
• Recruitment Status: Recruiting
• First Posted: November 18, 2022
• Last Update Posted: August 15, 2023
• Sponsor: Dr. Falk Pharma GmbH
• Information provided by (Responsible Party): Dr. Falk Pharma GmbH

Tracking Information

• First Submitted Date: November 3, 2022
• First Posted Date: November 18, 2022
• Last Update Posted Date: August 15, 2023
• Actual Study Start Date: January 3, 2023
• Estimated Primary Completion Date: January 2025 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: November 10, 2022): 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 ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Different Doses of Naronapride vs. Placebo in Gastroparesis
• Official Title: 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
• Brief Summary: 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Gastroparesis

Intervention

• Drug: Naronapride
  Naronapride is a 5HT-4 agonist
• Drug: Placebo
  Placebo

Study Arms

• Experimental: Naronapride 10 mg
  Intervention: Drug: Naronapride
• Experimental: Naronapride 20 mg
  Intervention: Drug: Naronapride
• Experimental: Naronapride 40 mg
  Intervention: Drug: Naronapride
• Placebo Comparator: Placebo
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: November 10, 2022): 320
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 2025
• Estimated Primary Completion Date: January 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

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,

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Listed Location Countries: Belgium

Administrative Information

• NCT Number: NCT05621811
• Other Study ID Numbers: NAT-19/GPX
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Dr. Falk Pharma GmbH
• Original Responsible Party: Same as current
• Current Study Sponsor: Dr. Falk Pharma GmbH
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Dr. Falk Pharma GmbH
• Verification Date: August 2023