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An Open-Label, Long-Term, Multi-Center, Intrathecal Ziconotide (PRIALT) Effectiveness and Safety Trial (ZEST) in Patients With Chronic Severe Pain

Phase 3
18 Years
Not Enrolling

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Trial Information

An Open-Label, Long-Term, Multi-Center, Intrathecal Ziconotide (PRIALT) Effectiveness and Safety Trial (ZEST) in Patients With Chronic Severe Pain

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

- 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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Masking: Open Label, Primary Purpose: Treatment


United States: Food and Drug Administration

Study ID:




Start Date:

February 2004

Completion Date:

Related Keywords:

  • Pain
  • Intrathecal



Roswell Park Cancer Institute Buffalo, New York  14263
Lehigh Valley Hospital Allentown, Pennsylvania  18103
University of Kentucky Lexington, Kentucky  40536-0098
Outcomes Research International Tucson, Arizona  85711
Innovative Spine Care Little Rock, Arkansas  72205
Advanced Pain Institute Duarte, California  91010
Pain Care Specialists Colorado Springs, Colorado  80907
Pain Consultants of Oregon Eugene, Oregon  97401
Clinical Pharmacology Services Tampa, Florida  
Alabama Pain Center Huntsville, Alabama  35801
Center for Pain Management Huntsville, Alabama  35801
Otto Uhrik, MD Sun City West, Arizona  85373
The RC Goodman Pain Institute Fort Smith, Arkansas  72901
Shreenath Clinical Services Beverly Hills, California  90211
Bay Area Pain Center Los Gatos, California  95032
Northridge Surgery & Pain Management Center Northridge, California  91324
Pacific Pain Medicine Consultants Oceanside, California  92056
Pacific Pain Treatment Centers San Francisco, California  94109
Galileo Surgery Center San Luis Obispo, California  93405
Pain Relief Center of Colorado Arvada, Colorado  80002
Rocky Mountain Clinical Research Golden, Colorado  80401
Comprehensive Pain and Headache Treatment Centers, LLC Derby, Connecticut  06418
Florida Institute of Medical Research Jacksonville, Florida  32207
Space Coast Pain Institute Merritt Island, Florida  32953
West Gables Rehabilitation Hospital Miami, Florida  33155
Sarasota Pain Associates Sarasota, Florida  34243
Shepherd Center, Inc. Atlanta, Georgia  30309
Comprehensive Pain Care, PC Marietta, Georgia  30060
The University of Chicago, Dept. of Surgery, Section of Neurosurgery Chicago, Illinois  60637
Indianapolis Neurosurgical Group Indianapolis, Indiana  46202
University of Iowa Health Care Iowa City, Iowa  52242
Des Moines Orthopedic Surgeons West Des Moines, Iowa  50266
Pain Control Network, PSC/PCN Surgical Suites, LLC Louisville, Kentucky  40205
Wayne State University - School of Medicine Detroit, Michigan  48201
Medical Advanced Pain Specialists (MAPS) Minneapolis, Minnesota  55433
The Center for Pain Medicine Hattiesburg, Mississippi  39402
Pain Management Associates, Clinical Research Independence, Missouri  64055
St. John's Regional Healthcare Springfield, Missouri  65804
Pain Management - Anesthesiology Las Vegas, Nevada  89117
Dr. O'Connell's Pain Care Centers, Inc. Somersworth, New Hampshire  03878
All Island Pain Consultants Bay Shore, New York  11706
Cohn Pain Management Center Bethpage, New York  11714
New York Presbyterian Hospital/Cornell Medical Center New York, New York  10021
NYU Pain Management Center New York, New York  10016
Medical Pain Management of Central New York Syracuse, New York  13210
Duke Medical Center Pain Clinic Durham, North Carolina  27705
The Center for Clinical Research Winston-Salem, North Carolina  27103
Cincinnati Centers for Pain Relief, Inc. Hamilton, Ohio  45011
PETC Research Group, Inc. Tulsa, Oklahoma  74137
Pain Management Consultants, PC Portland, Oregon  97225
Magee Rehabilitation Philadelphia, Pennsylvania  19102
Carolinas Center for Advanced Management of Pain Spartanburg, South Carolina  29302
Avera St. Luke's Hospital Aberdeen, South Dakota  57401
Dallas Spine Care P.A. Dallas, Texas  75235
Advanced Pain Medicine Dallas, Texas  75237
The University of Texas Medical Branch Galveston, Texas  77555
International Pain Institute Lubbock, Texas  79413
American Pain & Wellness, PA Plano, Texas  75093
Consultants in Pain Research, PA San Antonio, Texas  78217
Lifetree Clinical Research Salt Lake City, Utah  84106
University of Utah Pain Management Center Salt Lake City, Utah  84108
Pain Management Center, University of Virginia Charlottesville, Virginia  22903
The Center for Pain Relief Charleston, West Virginia  25301