A Study to Evaluate the Safety and Efficacy of NG101 in Adult Participants With Symptomatic Diabetic or Idiopathic Gastroparesis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety and efficacy of various dose levels of NG101 compared with placebo in adult participants with gastroparesis during 12 weeks of treatment.

Detailed Description
-----------------
This is a randomized, double-blind, parallel-group , placebo-controlled, multicenter US-based study to evaluate the safety and efficacy of 3 dose levels of NG101 (Metopimazine mesylate) compared with placebo in participants with diabetic or idiopathic gastroparesis. The study will enroll approximately 140 participants. Following the Screening Period, there is a 2-week Pretreatment Period during which participants will complete an electronic daily diary. Participants eligible for the clinical study will be randomly assigned (in a 1:1:1:1 ratio) to receive either NG101 5 mg, 10 mg, or 20 mg, or matching placebo during a 12-week Treatment Period. All participants will be asked to take one capsule 30 minutes before a meal 3 times a day and 30 minutes before bedtime for a total of 4 capsules daily (QID). The total duration of the study for each participant will be approximately 20 weeks.

Official Title
-----------------
A Phase 2 Randomized, Double-blind, Placebo-Controlled, Parallel-Group Study, of the Safety and Efficacy of NG101 Administered Orally to Patients With Gastroparesis

Conditions
-----------------
Diabetic Gastroparesis, Idiopathic Gastroparesis

Intervention / Treatment
-----------------
* Drug: NG101
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients with diabetic or idiopathic gastroparesis Symptoms consistent with gastroparesis (nausea, vomiting, early satiety, post-prandial fullness, and abdominal pain) Documented evidence of no mechanical obstruction Delayed gastric emptying as demonstrated by gastric scintigraphy or breath test Exclusion Criteria: Uncontrolled diabetes (defined as HgbA1c > 10%) Severe postural symptoms or evidence of unexplained recurrent dizziness Participant has received and tolerated domperidone and showed no notable symptomatic improvement in gastroparesis symptoms Participant has had endoscopic pyloric injections of botulinum toxin within the 6 months prior to the Screening Visit. Participant engages in daily recreational use of marijuana Prolactin levels > 2 x ULN

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NG101 - 5 mg<br>NG101 5 mg, capsules, orally, QID (4 times a day) for up to 12 weeks | Drug: NG101<br>* Capsules<br>* Other names: metopimazine mesylate;|
| Experimental: NG101 - 10 mg<br>NG101 10 mg, capsules, orally, QID (4 times a day) for up to 12 weeks | Drug: NG101<br>* Capsules<br>* Other names: metopimazine mesylate;|
| Experimental: NG101 - 20 mg<br>NG101 20 mg, capsules, orally, QID (4 times a day) for up to 12 weeks | Drug: NG101<br>* Capsules<br>* Other names: metopimazine mesylate;|
| Placebo Comparator: Placebo<br>Placebo-matching, capsules, orally, QID (4 times a day) for up to 12 weeks | Drug: Placebo<br>* Capsules<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Severity of Nausea | Change from Baseline at weeks 7 through12 as measured by patient's daily diary entries during participation in the study. | Baseline to Week 12 | 
| Incidence and severity of Adverse Events | Incidence and severity of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs). | Baseline to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline of Symptoms | Change from baseline at Weeks 7 through 12 as measured by patient's daily diary entries during participation in the study for number of discrete episodes of vomiting. | Baseline to Week 12 | 
| Change from Baseline of Symptoms | Change from baseline at Weeks 7 through 12 as measured by patient's daily diary entries during participation in the study for early satiety severity score. | Baseline to Week 12 | 
| Change from Baseline | Change from baseline at Weeks 7 through 12 as measured by patient's daily diary entries during participation in the study for postprandial fullness severity score. | Baseline to Week 12 | 
| Change from Baseline | Change from baseline at Weeks 7 through 12 as measured by patient's daily diary entries during participation in the study for abdominal pain severity score. | Baseline to Week 12 | 
| Change from Baseline | Change from baseline at Weeks 7 through 12 as measured by patient's daily diary entries during participation in the study for 3-symptom severity score. | Baseline to Week 12 | 
| Change from Baseline | Change from baseline at Weeks 7 through 12 as measured by patient's daily diary entries during participation in the study for 4-symptom severity score. | Baseline to Week 12 |