Study start date: February 1, 2004Actual date on which the first participant was enrolled.
The purpose of this open-label study is to give chronic severe pain patients with existing intrathecal pump systems access to ziconotide.
Official TitleAn Open-Label, Long-Term, Multi-Center, Intrathecal Ziconotide (PRIALT) Effectiveness and Safety Trial (ZEST) in Patients With Chronic Severe Pain
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
300 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
How participants are assigned to different groups/arms In this clinical study, participants are assigned to groups based on specific criteria, such as their medical history or a doctor's recommendation. This approach ensures that treatments are given to those who may benefit the most, based on known factors.
Other Ways to Assign Participants Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias. None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.
How the interventions assigned to participants is kept confidential Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.
Other Ways to Mask Information Single-blind: Participants do not know which treatment they are receiving, but researchers do. Double-blind: Neither participants nor researchers know which treatment is given. Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given. Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Pain
Criteria
8 inclusion criteria required to participate
Each patient must have chronic severe pain of malignant or nonmalignant etiology with inadequate pain relief from or intolerance to conventional therapy
Each patient must have a predicted life expectancy of greater than or equal to 6 weeks relative to baseline
Each patient must be able to respond to the Visual Analog Scale of Pain Intensity (VASPI)
Each patient must have an implanted programmable SynchroMed infusion device or a CADD-Micro external programmable infusion device and spinal catheter (hereafter "IT pump and spinal catheter") prior to enrollment into this trial. (If a patient has an external pump, the Investigator must ensure that the patient is at a low risk for infection and that the patient is capable of maintaining good personal hygiene. The Investigator must have demonstrated the ability to successfully manage patients with external pumps prior to enrolling a patient in this trial.)
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5 exclusion criteria prevent from participating
Presence of pregnancy or lactation
Participation in another investigational drug or device trial within the preceding 30 days
Presence of known hypersensitivity to PRIALT or any of its components
Presence of any contraindication to continued IT therapy (for example, infection at the pump or catheter externalization site, uncontrolled bleeding diathesis, spinal canal obstruction that impairs cerebrospinal fluid \[CSF\] circulation, or patient and caregiver inability to manage and protect the IT pump and spinal catheter system and return for clinic follow up visits)
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Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.