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The purpose of this study is to understand the effects of intrathecal ziconotide (an experimental pain medication) when the dose is slowly increased over a 3-week period in patients with severe chronic pain. During the weaning phase, the study will also gather information about switching from other intrathecal or IT medication (slowly pumped directly into the space around the spine) to other systemic pain medication (by mouth or through the skin using a patch). After being weaned off current IT medication, patients will be placed on IT ziconotide or placebo (non-active substance) as well as being allowed a stable dose of systemic pain medications.
Patients who complete this study may be eligible for long-term ziconotide therapy via extension protocol ELN92045-352.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prialt (ziconotide) | Drug |
Inclusion Criteria:
Males and their partner(s) of childbearing age must use adequate, appropriate contraceptive methods.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tennesee Valley Pain Consultants - Center For Pain Management | Huntsville | Alabama | 35801 | United States | ||
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| Label | URL |
|---|---|
| Ziconotide in severe chronic pain (search using ziconotide) | View source |
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| The Pain Center |
| Northport |
| Alabama |
| 35476 |
| United States |
| Outcomes Research International | Tucson | Arizona | 85711 | United States |
| The RC Goodman Pain Institute: Clinical Research | Fort Smith | Arkansas | 72901 | United States |
| Hot Springs Mercy Pain Clinic | Hot Springs | Arkansas | 71913 | United States |
| Innovative Spine Care | Little Rock | Arkansas | 72205 | United States |
| Advanced Pain Medicine | Bakersfield | California | 93311 | United States |
| Advanced Pain Institute | Duarte | California | 91010 | United States |
| UCSD Medical Center, Thornton Hospital | La Jolla | California | 92037 | United States |
| Abaci and Massey Pain Center | Los Gatos | California | 95032 | United States |
| UCSF Pain Management Center | San Francisco | California | 94143-1654 | United States |
| Pain Care Specialists | Colorado Springs | Colorado | 80907 | United States |
| Clinical Pharmacology Services, Inc. | Tampa | Florida | 33617 | United States |
| Georgia Medical Research Institute | Marietta | Georgia | 30060 | United States |
| Rush Presbyterian - St. Luke's Medical Center | Chicago | Illinois | 60612 | United States |
| University of Kentucky, Dept Anesthesiology | Lexington | Kentucky | 40536 | United States |
| Johns Hopkins Hospital, Division of Pain Management | Baltimore | Maryland | 21205 | United States |
| Arnold Pain Management | Boston | Massachusetts | 02215 | United States |
| Edina Medical Pain Center | Edina | Minnesota | 55435 | United States |
| Research Medical Center - Pain Institute | Kansas City | Missouri | 64132 | United States |
| Yellowstone Medical Center East | Billings | Montana | 59101 | United States |
| Huntington Center for Pain Treatment | Huntington | New York | 11743 | United States |
| Weill Medical College of Cornell University | New York | New York | 10021 | United States |
| Medical Pain Management of Central NY | Syracuse | New York | 13210 | United States |
| Center For Clinical Research | Winston-Salem | North Carolina | 27103 | United States |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Pain Institute of Tulsa | Tulsa | Oklahoma | 74137 | United States |
| Pain Consultants of Oregon | Eugene | Oregon | 97401 | United States |
| Legacy Holladay Park Medical Center | Portland | Oregon | 97232 | United States |
| Penn State University Hospital | Hershey | Pennsylvania | 17033 | United States |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| Advanced Clinical Concepts | Temple | Pennsylvania | 19560 | United States |
| Neurosurgery Foundation | Providence | Rhode Island | 02903 | United States |
| MUSC, Neurological Surgery | Charleston | South Carolina | 29425 | United States |
| Methodist Comprehensive Pain Institute | Memphis | Tennessee | 38104 | United States |
| Clinical Research Associates, Inc. | Nashville | Tennessee | 37203 | United States |
| University of Texas M.D. Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Texas Tech University HSC | Lubbock | Texas | 79430 | United States |
| Consultants in Pain Research | San Antonio | Texas | 78217 | United States |
| Alpine Pain and Addiction Medicine | Salt Lake City | Utah | 84107 | United States |
| Advanced Pain Management and Rehabilitation | Virginia Beach | Virginia | 23454 | United States |
| University of Washington Medical Center - Pain Center | Seattle | Washington | 98195 | United States |
| Center for Pain Relief | Charleston | West Virginia | 25301 | United States |
| Cardinal Clinical Research Center | Cudahy | Wisconsin | 53110 | United States |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C078452 | ziconotide |
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