Overcoming Challenges in a Multicenter Psychiatric Clinical Trial: Bioequivalence Assessment of Paliperidone Palmitate Extended-Release Injectable Suspension, 546 mg

Overcoming Challenges in a Multicenter Psychiatric Clinical Trial: Bioequivalence Assessment of Paliperidone Palmitate Extended-Release Injectable Suspension, 546 mg

Welcome to our blog, where we dive into the intricacies of the Multicenter Psychiatric Clinical Trial for Bioequivalence Assessment of Paliperidone Palmitate Extended-Release Injectable Suspension, 546 mg. We explore the strategies and solutions that helped us navigate through challenges in patient management, randomization, recruitment timelines, and protocol adherence.

Study Overview:

The study aimed to characterize the pharmacokinetic profile and assess the bioequivalence of Paliperidone Palmitate Extended-Release Injectable Suspension, 546 mg (TEST) compared to RLDs [US RLD {R1: Invega Trinza® (Paliperidone Palmitate Extended-Release Injectable Suspension, 546 mg)} and EU RLD {R2: Trevicta (Paliperidone Palmitate Prolonged-Release suspension for injection, 546 mg)}], in Patients with Schizophrenia already receiving a stable regimen of Paliperidone Palmitate Injectable Suspension.


Study Design:

A randomized, open-label, two-stage, three-arm, multicenter, parallel-group, multiple-dose, steady-state study to compare the bioavailability and characterize the pharmacokinetic profile of three formulations (Test vs. US RLD and Test vs. EU RLD) of Paliperidone Palmitate Extended-Release Injectable Suspension, 546 mg in patients with Schizophrenia already receiving a stable regimen of Paliperidone Palmitate Injectable Suspension.


Challenges and Solutions:

Effective strategies and meticulous planning addressed key challenges in patient management, randomization, recruitment, and ensuring successful trial outcomes.

ChallengesSolutions
Patient Identification and Stabilization Protocol
Identification of Patients with Schizophrenia who are already receiving a stable regimen of paliperidone palmitate injectable suspension.• Identified investigator sites with a substantial patient pool and excellent clinical trial experience.
• The protocol was designed for the stabilization of patients prior to randomization.
• Non-study medication (NIMP) was supplied to the site for patient stabilization in the study, to meet the study requirements.
Randomization Management for Large Patient Cohorts
Large sample size (540 patients) and maintenance of randomization blocks of six at each site.• The patient pool was discussed with the Principal Investigator during the Site Selection Visit (SSV), and the randomization targets were allocated to each site accordingly.
Additional patients were stabilized to achieve a randomization block of six.
Recruitment Timeline Management
Recruitment timeline (7 months to save new batch of test IMP)• Recruitment timeline was discussed during SSV and SIV.
• Periodic follow-ups were conducted, and site recruitment challenges were resolved in a timely manner.
Ensuring Female Participant Enrollment
Protocol requirement to enroll approximately 20 to 30% female participants in the study.• Study requirements were discussed with the PI during SSV and SIV.
• The male-to-female ratio was continuously monitored centrally, and sites were instructed to enroll female patients as needed.
Managing Long Study and PK Sample Collection Duration
Long study duration (16 months) and PK sample collection duration (3 months)• Discussed with the PI to select patients who have been under their treatment for a longer duration and are from nearby areas.
• Patients were informed of all study visits during the ICF presentation and were periodically updated about upcoming visits.
• Defined patient home visits to prevent missing samples.
Managing eGFR-Based Withdrawal Criteria
Withdrawal criteria: eGFR below 80 mL/min/m²• The requirement for proper hydration prior to sample collection was defined in the study plan, and study personnel were trained accordingly during the SIV.
• A double-check mechanism was established to prevent dosing of patients who meet the withdrawal criteria.

Achievements:

  • 540 patients were successfully enrolled in the study within a remarkable period of 7 months, demonstrating effective patient enrollment strategies.
  • Efficient trial execution with 40% female participation in the trial.
  • Recruitment target was achieved early, saving the requirement for a new batch of test IMP and thereby resulting in significant cost savings for the sponsor,

Leverage Lambda & Novum’s extensive experience & proven track record to accelerate your Psychiatry clinical trials


Facebook
Twitter
LinkedIn