Ziconotide Effectiveness and Safety Trial in Patients With Chronic Severe Pain
An Open-Label, Long-Term, Multi-Center, Intrathecal Ziconotide (PRIALT) Effectiveness and Safety Trial (ZEST) in Patients With Chronic Severe Pain
1 other identifier
interventional
300
1 country
65
Brief Summary
The purpose of this open-label study is to give chronic severe pain patients with existing intrathecal pump systems access to ziconotide.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 pain
65 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 26, 2004
CompletedStudy Start
First participant enrolled
February 1, 2004
CompletedFirst Posted
Study publicly available on registry
February 4, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2005
CompletedDecember 14, 2015
December 1, 2015
1.1 years
January 26, 2004
December 10, 2015
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.)
- Each patient must be at least 18 years of age.
- Each patient must be competent to give written informed consent and has given written informed consent prior to performance of any study-related procedures. Reasonable accommodation of visually impaired patients will be allowed.
- Each patient is willing and able to comply with the protocol requirements.
- Each female patient of childbearing potential must agree to use adequate contraceptive methods while on PRIALT as determined by the Investigator.
You may not qualify if:
- 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).
- Presence of any condition (for example, psychosis, severe depression or suicidal ideation, homicidality, somatization disorder, active substance abuse, cognitive deficits, dementia or other serious medical or psychiatric condition) that in the Investigator's opinion precludes the patient's ability to participate in this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (65)
Alabama Pain Center
Huntsville, Alabama, 35801, United States
Center for Pain Management
Huntsville, Alabama, 35801, United States
Otto Uhrik, MD
Sun City West, Arizona, 85373, United States
Outcomes Research International
Tucson, Arizona, 85712, United States
The RC Goodman Pain Institute
Fort Smith, Arkansas, 72901, United States
Innovative Spine Care
Little Rock, Arkansas, 72205, United States
Shreenath Clinical Services
Beverly Hills, California, 90211, United States
Advanced Pain Institute
Duarte, California, 91010, United States
Shreenath Clinical Services
Lake Forest, California, 92630, United States
Shreenath Clinical Services
Long Beach, California, 90807, United States
Bay Area Pain Center
Los Gatos, California, 95032, United States
Northridge Surgery & Pain Management Center
Northridge, California, 91324, United States
Pacific Pain Medicine Consultants
Oceanside, California, 92056, United States
Pacific Pain Treatment Centers
San Francisco, California, 94109, United States
Galileo Surgery Center
San Luis Obispo, California, 93405, United States
Pain Relief Center of Colorado
Arvada, Colorado, 80002, United States
Pain Care Specialists
Colorado Springs, Colorado, 80907, United States
Rocky Mountain Clinical Research
Golden, Colorado, 80401, United States
Comprehensive Pain and Headache Treatment Centers, LLC
Derby, Connecticut, 06418, United States
Florida Institute of Medical Research
Jacksonville, Florida, 32207, United States
Space Coast Pain Institute
Merritt Island, Florida, 32953, United States
West Gables Rehabilitation Hospital
Miami, Florida, 33155, United States
Sarasota Pain Associates
Sarasota, Florida, 34243, United States
Clinical Pharmacology Services
Tampa, Florida, 33617, United States
Shepherd Center, Inc.
Atlanta, Georgia, 30309, United States
Comprehensive Pain Care, PC
Marietta, Georgia, 30060, United States
The University of Chicago, Dept. of Surgery, Section of Neurosurgery
Chicago, Illinois, 60637, United States
Indianapolis Neurosurgical Group
Indianapolis, Indiana, 46202, United States
University of Iowa Health Care
Iowa City, Iowa, 52242, United States
Des Moines Orthopedic Surgeons
West Des Moines, Iowa, 50266, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
Pain Control Network, PSC/PCN Surgical Suites, LLC
Louisville, Kentucky, 40205, United States
Wayne State University - School of Medicine
Detroit, Michigan, 48201, United States
Medical Advanced Pain Specialists (MAPS)
Minneapolis, Minnesota, 55433, United States
The Center for Pain Medicine
Hattiesburg, Mississippi, 39402, United States
Pain Management Associates, Clinical Research
Independence, Missouri, 64055, United States
St. John's Regional Healthcare
Springfield, Missouri, 65804, United States
Pain Management - Anesthesiology
Las Vegas, Nevada, 89117, United States
Dr. O'Connell's Pain Care Centers, Inc.
Somersworth, New Hampshire, 03878, United States
All Island Pain Consultants
Bay Shore, New York, 11706, United States
Cohn Pain Management Center
Bethpage, New York, 11714, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
NYU Pain Management Center
New York, New York, 10016, United States
New York Presbyterian Hospital/Cornell Medical Center
New York, New York, 10021, United States
Medical Pain Management of Central New York
Syracuse, New York, 13210, United States
Duke Medical Center Pain Clinic
Durham, North Carolina, 27705, United States
The Center for Clinical Research
Winston-Salem, North Carolina, 27103, United States
Cincinnati Centers for Pain Relief, Inc.
Hamilton, Ohio, 45011, United States
PETC Research Group, Inc.
Tulsa, Oklahoma, 74137, United States
Pain Consultants of Oregon
Eugene, Oregon, 97401, United States
Pain Management Consultants, PC
Portland, Oregon, 97225, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103, United States
Magee Rehabilitation
Philadelphia, Pennsylvania, 19102, United States
Carolinas Center for Advanced Management of Pain
Spartanburg, South Carolina, 29302, United States
Avera St. Luke's Hospital
Aberdeen, South Dakota, 57401, United States
Dallas Spine Care P.A.
Dallas, Texas, 75235, United States
Advanced Pain Medicine
Dallas, Texas, 75237, United States
The University of Texas Medical Branch
Galveston, Texas, 77555, United States
International Pain Institute
Lubbock, Texas, 79413, United States
American Pain & Wellness, PA
Plano, Texas, 75093, United States
Consultants in Pain Research, PA
San Antonio, Texas, 78217, United States
Lifetree Clinical Research
Salt Lake City, Utah, 84106, United States
University of Utah Pain Management Center
Salt Lake City, Utah, 84108, United States
Pain Management Center, University of Virginia
Charlottesville, Virginia, 22903, United States
The Center for Pain Relief
Charleston, West Virginia, 25301, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 26, 2004
First Posted
February 4, 2004
Study Start
February 1, 2004
Primary Completion
March 1, 2005
Last Updated
December 14, 2015
Record last verified: 2015-12