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

Condition	Treatment or Intervention	Phase
Pain	Drug: Ziconotide	Phase III

Further Study Details: 

Expected Total Enrollment:  300

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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 accomodation 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 determine 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.

Alabama
      Alabama Pain Center, Huntsville,  Alabama,  35801,  United States; No longer recruiting
      Center for Pain Management, Huntsville,  Alabama,  35801,  United States; No longer recruiting
Arizona
      Outcomes Research International, Tucson,  Arizona,  85712,  United States; No longer recruiting
      Otto Uhrik, MD, Sun City West,  Arizona,  85373,  United States; No longer recruiting
Arkansas
      Innovative Spine Care, Little Rock,  Arkansas,  72205,  United States; No longer recruiting
      The RC Goodman Pain Institute, Fort Smith,  Arkansas,  72901,  United States; No longer recruiting
California
      Bay Area Pain Center, Los Gatos,  California,  95032,  United States; No longer recruiting
      Galileo Surgery Center, San Luis Obispo,  California,  93405,  United States; No longer recruiting
      Pacific Pain Treatment Centers, San Francisco,  California,  94109,  United States; No longer recruiting
      Shreenath Clinical Services, Long Beach,  California,  90807,  United States; No longer recruiting
      Shreenath Clinical Services, Lake Forest,  California,  92630,  United States; No longer recruiting
      Shreenath Clinical Services, Beverly Hills,  California,  90211,  United States; No longer recruiting
      Advanced Pain Institute, Duarte,  California,  91010,  United States; No longer recruiting
      Pacific Pain Medicine Consultants, Oceanside,  California,  92056,  United States; No longer recruiting
      Northridge Surgery & Pain Management Center, Northridge,  California,  91324,  United States; No longer recruiting
Colorado
      Rocky Mountain Clinical Research, Golden,  Colorado,  80401,  United States; No longer recruiting
      Pain Relief Center of Colorado, Arvada,  Colorado,  80002,  United States; No longer recruiting
      Pain Care Specialists, Colorado Springs,  Colorado,  80907,  United States; No longer recruiting
Connecticut
      Comprehensive Pain and Headache Treatment Centers, LLC, Derby,  Connecticut,  06418,  United States; No longer recruiting
Florida
      Clinical Pharmacology Services, Tampa,  Florida,  33617,  United States; No longer recruiting
      Sarasota Pain Associates, Sarasota,  Florida,  34243,  United States; No longer recruiting
      Florida Institute of Medical Research, Jacksonville,  Florida,  32207,  United States; No longer recruiting
      Space Coast Pain Institute, Merritt Island,  Florida,  32953,  United States; No longer recruiting
      West Gables Rehabilitation Hospital, Miami,  Florida,  33155,  United States; No longer recruiting
Georgia
      Shepherd Center, Inc., Atlanta,  Georgia,  30309,  United States; No longer recruiting
      Comprehensive Pain Care, PC, Marietta,  Georgia,  30060,  United States; No longer recruiting
Illinois
      The University of Chicago, Dept. of Surgery, Section of Neurosurgery, Chicago,  Illinois,  60637,  United States; No longer recruiting
Indiana
      Indianapolis Neurosurgical Group, Indianapolis,  Indiana,  46202,  United States; No longer recruiting
Iowa
      Des Moines Orthopedic Surgeons, West Des Moines,  Iowa,  50266,  United States; No longer recruiting
      University of Iowa Health Care, Iowa City,  Iowa,  52242,  United States; No longer recruiting
Kentucky
      Pain Control Network, PSC/PCN Surgical Suites, LLC, Louisville,  Kentucky,  40205,  United States; No longer recruiting
      University of Kentucky, Lexington,  Kentucky,  40536,  United States; No longer recruiting
Michigan
      Wayne State University - School of Medicine, Detroit,  Michigan,  48201,  United States; No longer recruiting
Minnesota
      Medical Advanced Pain Specialists (MAPS), Minneapolis,  Minnesota,  55433,  United States; No longer recruiting
Mississippi
      The Center for Pain Medicine, Hattiesburg,  Mississippi,  39402,  United States; No longer recruiting
Missouri
      Pain Management Associates, Clinical Research, Independence,  Missouri,  64055,  United States; No longer recruiting
      St. John's Regional Healthcare, Springfield,  Missouri,  65804,  United States; No longer recruiting
Nevada
      Pain Management - Anesthesiology, Las Vegas,  Nevada,  89117,  United States; No longer recruiting
New Hampshire
      Dr. O'Connell's Pain Care Centers, Inc., Somersworth,  New Hampshire,  03878,  United States; No longer recruiting
New York
      All Island Pain Consultants, Bay Shore,  New York,  11706,  United States; No longer recruiting
      Medical Pain Management of Central New York, Syracuse,  New York,  13210,  United States; No longer recruiting
      Cohn Pain Management Center, Bethpage,  New York,  11714,  United States; No longer recruiting
      Roswell Park Cancer Institute, Buffalo,  New York,  14263,  United States; No longer recruiting
      New York Presbyterian Hospital/Cornell Medical Center, New York,  New York,  10021,  United States; No longer recruiting
      NYU Pain Management Center, New York,  New York,  10016,  United States; No longer recruiting
North Carolina
      Duke Medical Center Pain Clinic, Durham,  North Carolina,  27705,  United States; No longer recruiting
      The Center for Clinical Research, Winston Salem,  North Carolina,  27103,  United States; No longer recruiting
Ohio
      Cincinnati Centers for Pain Relief, Inc., Hamilton,  Ohio,  45011,  United States; No longer recruiting
Oklahoma
      PETC Research Group, Inc., Tulsa,  Oklahoma,  74137,  United States; No longer recruiting
Oregon
      Pain Management Consultants, PC, Portland,  Oregon,  97225,  United States; No longer recruiting
      Pain Consultants of Oregon, Eugene,  Oregon,  97401,  United States; No longer recruiting
Pennsylvania
      Lehigh Valley Hospital, Allentown,  Pennsylvania,  18103,  United States; No longer recruiting
      Magee Rehabilitation, Philadelphia,  Pennsylvania,  19102,  United States; No longer recruiting
South Carolina
      Carolinas Center for Advanced Management of Pain, Spartanburg,  South Carolina,  29302,  United States; No longer recruiting
South Dakota
      Avera St. Luke's Hospital, Aberdeen,  South Dakota,  57401,  United States; No longer recruiting
Texas
      Consultants In Pain Research, PA, San Antonio,  Texas,  78217,  United States; No longer recruiting
      International Pain Institute, Lubbock,  Texas,  79413,  United States; No longer recruiting
      The University of Texas Medical Branch, Galveston,  Texas,  77555,  United States; No longer recruiting
      Dallas Spine Care P.A., Dallas,  Texas,  75235,  United States; No longer recruiting
      Advanced Pain Medicine, Dallas,  Texas,  75237,  United States; No longer recruiting
      American Pain & Wellness, PA, Plano,  Texas,  75093,  United States; No longer recruiting
Utah
      Lifetree Clinical Research, Salt Lake City,  Utah,  84106,  United States; No longer recruiting
      University of Utah Pain Management Center, Salt Lake City,  Utah,  84108,  United States; No longer recruiting
Virginia
      Pain Management Center, University of Virginia, Charlottesville,  Virginia,  22903,  United States; No longer recruiting
West Virginia
      The Center For Pain Relief, Charleston,  West Virginia,  25301,  United States; No longer recruiting

Study ID Numbers:  ELN92045-501
Record last reviewed:  November 2004
Last Updated:  December 9, 2004
Record first received:  January 26, 2004
ClinicalTrials.gov Identifier:  NCT00076544
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08