A Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adult Subjects With Idiopathic Gastroparesis.

Conditions

• Idiopathic Gastroparesis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• CIN-102 Dose 15mg — DRUG
  Twice daily for 12 weeks
• Placebo — DRUG
  Twice daily for 12 weeks
• CIN-102 Dose 10mg — DRUG
  Twice daily for 12 weeks

Study Details

The goal of this clinical trial is to evaluate if the study drug CIN-102 (deudomperidone) can help to decrease nausea severity associated with idiopathic gastroparesis severity in adult subjects. The main questions it aims to answer are: * To evaluate the efficacy of CIN-102 on symptoms of gastroparesis when given to patients with idiopathic gastroparesis compared to a placebo * To evaluate the safety of CIN-102 when given to patients with idiopathic gastroparesis compared to a placebo Participants will go through the following schedule: * Pre-screening (1 visit) * Screening \& Lead-In (1-2 visits) * Will complete a Gastric Emptying Breath Test (GEBT) * Will complete daily diary and other Patient Reported Outcomes (PROs) as described in the protocol to assess eligibility for continued study participation. * Lead-In Period (1 visit) * 12-week treatment period (7 visits) * Study drug taken twice daily by mouth * Will complete daily diaries and other PROs as described in protocol * 1 week follow-up (1 visit) Researchers will compare the effects of the following treatments: * 15 mg CIN-102, taken orally BID for 12 weeks * 10 mg CIN-102, taken orally BID for 12 weeks * Placebo for CIN-102, taken orally BID for 12 weeks

Key Dates

First listed

Mar 27, 2025

Start date

Jan 29, 2025

Status verified

Sep 2025

Primary completion

May 7, 2026

Completion

May 7, 2026

Study Design

Enrollment

416 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: CIN-102: 15mg
  15 mg CIN-102, taken orally BID for 12 weeks
• Experimental: CIN-102: 10mg
  10 mg CIN-102, taken orally BID for 12 weeks
• Placebo Comparator: Placebo for CIN-102
  Placebo for CIN-102, taken orally BID for 12 weeks

Primary Outcome Measure

The effect of CIN-102 to significantly decrease nausea severity as compared to baseline based on the average ANMS GCSI-DD Nausea Subscale Score. [ Time Frame: Over the last 2 weeks of the 12-week Treatment Period as compared to Baseline ]

Locations (85)

Find similar trials in Birmingham, AL

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