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

The purpose of this open-label study is to give chronic severe pain patients with existing intrathecal pump systems access to ziconotide.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Ziconotide

• Study Type: Interventional
• Enrollment: 300
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • Alabama Pain Center
    • Huntsville, Alabama, United States, 35801
      • Center for Pain Management
  • Arizona
    • Sun City West, Arizona, United States, 85373
      • Otto Uhrik, MD
    • Tucson, Arizona, United States, 85712
      • Outcomes Research International
  • Arkansas
    • Fort Smith, Arkansas, United States, 72901
      • The RC Goodman Pain Institute
    • Little Rock, Arkansas, United States, 72205
      • Innovative Spine Care
  • California
    • Beverly Hills, California, United States, 90211
      • Shreenath Clinical Services
    • Duarte, California, United States, 91010
      • Advanced Pain Institute
    • Lake Forest, California, United States, 92630
      • Shreenath Clinical Services
    • Long Beach, California, United States, 90807
      • Shreenath Clinical Services
    • Los Gatos, California, United States, 95032
      • Bay Area Pain Center
    • Northridge, California, United States, 91324
      • Northridge Surgery & Pain Management Center
    • Oceanside, California, United States, 92056
      • Pacific Pain Medicine Consultants
    • San Francisco, California, United States, 94109
      • Pacific Pain Treatment Centers
    • San Luis Obispo, California, United States, 93405
      • Galileo Surgery Center
  • Colorado
    • Arvada, Colorado, United States, 80002
      • Pain Relief Center of Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Pain Care Specialists
    • Golden, Colorado, United States, 80401
      • Rocky Mountain Clinical Research
  • Connecticut
    • Derby, Connecticut, United States, 06418
      • Comprehensive Pain and Headache Treatment Centers, LLC
  • Florida
    • Jacksonville, Florida, United States, 32207
      • Florida Institute of Medical Research
    • Merritt Island, Florida, United States, 32953
      • Space Coast Pain Institute
    • Miami, Florida, United States, 33155
      • West Gables Rehabilitation Hospital
    • Sarasota, Florida, United States, 34243
      • Sarasota Pain Associates
    • Tampa, Florida, United States, 33617
      • Clinical Pharmacology Services
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Shepherd Center, Inc.
    • Marietta, Georgia, United States, 30060
      • Comprehensive Pain Care, PC
  • Illinois
    • Chicago, Illinois, United States, 60637
      • The University of Chicago, Dept. of Surgery, Section of Neurosurgery
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indianapolis Neurosurgical Group
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Health Care
    • West Des Moines, Iowa, United States, 50266
      • Des Moines Orthopedic Surgeons
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky
    • Louisville, Kentucky, United States, 40205
      • Pain Control Network, PSC/PCN Surgical Suites, LLC
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Wayne State University - School of Medicine
  • Minnesota
    • Minneapolis, Minnesota, United States, 55433
      • Medical Advanced Pain Specialists (MAPS)
  • Mississippi
    • Hattiesburg, Mississippi, United States, 39402
      • The Center for Pain Medicine
  • Missouri
    • Independence, Missouri, United States, 64055
      • Pain Management Associates, Clinical Research
    • Springfield, Missouri, United States, 65804
      • St. John's Regional Healthcare
  • Nevada
    • Las Vegas, Nevada, United States, 89117
      • Pain Management - Anesthesiology
  • New Hampshire
    • Somersworth, New Hampshire, United States, 03878
      • Dr. O'Connell's Pain Care Centers, Inc.
  • New York
    • Bay Shore, New York, United States, 11706
      • All Island Pain Consultants
    • Bethpage, New York, United States, 11714
      • Cohn Pain Management Center
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute
    • New York, New York, United States, 10016
      • NYU Pain Management Center
    • New York, New York, United States, 10021
      • New York Presbyterian Hospital/Cornell Medical Center
    • Syracuse, New York, United States, 13210
      • Medical Pain Management of Central New York
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke Medical Center Pain Clinic
    • Winston-Salem, North Carolina, United States, 27103
      • The Center for Clinical Research
  • Ohio
    • Hamilton, Ohio, United States, 45011
      • Cincinnati Centers for Pain Relief, Inc.
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74137
      • PETC Research Group, Inc.
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Pain Consultants of Oregon
    • Portland, Oregon, United States, 97225
      • Pain Management Consultants, PC
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • LeHigh Valley Hospital
    • Philadelphia, Pennsylvania, United States, 19102
      • Magee Rehabilitation
  • South Carolina
    • Spartanburg, South Carolina, United States, 29302
      • Carolinas Center for Advanced Management of Pain
  • South Dakota
    • Aberdeen, South Dakota, United States, 57401
      • Avera St. Luke's Hospital
  • Texas
    • Dallas, Texas, United States, 75235
      • Dallas Spine Care P.A.
    • Dallas, Texas, United States, 75237
      • Advanced Pain Medicine
    • Galveston, Texas, United States, 77555
      • The University of Texas Medical Branch
    • Lubbock, Texas, United States, 79413
      • International Pain Institute
    • Plano, Texas, United States, 75093
      • American Pain & Wellness, PA
    • San Antonio, Texas, United States, 78217
      • Consultants in Pain Research, PA
  • Utah
    • Salt Lake City, Utah, United States, 84106
      • Lifetree Clinical Research
    • Salt Lake City, Utah, United States, 84108
      • University of Utah Pain Management Center
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • Pain Management Center, University of Virginia
  • West Virginia
    • Charleston, West Virginia, United States, 25301
      • The Center for Pain Relief

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Masking: None (Open Label)

Collaborators and Investigators

• Sponsor: Elan Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: February 1, 2004
• Primary Completion (Actual): March 1, 2005

Study Registration Dates

• First Submitted: January 26, 2004
• First Submitted That Met QC Criteria: February 3, 2004
• First Posted (Estimate): February 4, 2004

Study Record Updates

• Last Update Posted (Estimate): December 14, 2015
• Last Update Submitted That Met QC Criteria: December 10, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Intrathecal
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Neuroprotective Agents; Protective Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Ziconotide
• Other Study ID Numbers: ELN92045-501