Exceeding Enrollment Goals in a Phase 3 Severe Hypertriglyceridemia Study

Study Objectives

• Study enrollment goal of 300 participants across 140 sites, across 17 countries.
• Alliance Clinical Network Goal: Enroll 1 participant/month.

Challenges
During the execution of the study, Alliance Clinical Network encountered some challenges, including:

1. Extensive eligibility criteria: Restrictive study eligibility criteria limit the number of participants who qualify for the study.
2. Screen Failure Rates: Screen fail rates for CNS trials routinely surpass those in other therapeutic areas due to the complicated nature of neurological and psychiatric disorders.
3. Participant Compliance: For participants to continue the study, they are required to complete >70% of daily pain diary entries and >80% of dosing compliance during their double-blind treatment period.