A Randomized, Parallel Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Paltusotine in Adults with Carcinoid Syndrome due to Well-Differentiated Neuroendocrine Tumors (CAREFNDR)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-519875-24-00

Acronym

CRN00808-12

Enrollment

Registered

2025-07-28

Start date

2025-09-26

Completion date

Unknown

Last updated

2025-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoid syndrome

Brief summary

Treatment group difference of change from baseline to Week 12 in flushing episodes/day averaged over the 14 days prior to Week 12.

Detailed description

Key Secondary: Treatment group difference of change from baseline to Week 12 in BMs/day averaged over the 14 days.

Interventions

DRUGPlacebo

DRUGPaltusotine 40 mg tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Treatment group difference of change from baseline to Week 12 in flushing episodes/day averaged over the 14 days prior to Week 12.	—

Secondary

Measure	Time frame
Key Secondary: Treatment group difference of change from baseline to Week 12 in BMs/day averaged over the 14 days.	—

Countries

Belgium, Denmark, France, Germany, Ireland, Italy, Poland, Romania, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026