Patient Registry of Intrathecal Ziconotide Management(PRIZM)



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:4/2/2016
Start Date:July 2013

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Patient Registry of Intrathecal Ziconotide Management (PRIZM): An Open-Label, Long Term, Multi-Center, Observational Study of PRIALT® (Ziconotide) Solution, Intrathecal Infusion, in Patients With Severe Chronic Pain

The objectives of this study are to evaluate the effectiveness, long-term safety,
tolerability, satisfaction with treatment, and health-related quality of life (HRQoL)
associated with Intrathecal PRIALT use for severe chronic pain of varying etiologies.


Inclusion Criteria:

- Patient is at least 18 years of age at the time of study entry.

- Patient who has severe chronic pain, whom IT therapy is warranted, and who is
intolerant of, or refractory to other treatments, such as systemic analgesics,
adjunctive therapies, and/or IT morphine.

- Patient is planned to be initiated on IT PRIALT as the sole agent in the pump at a
participated site.

- Patient has not received PRIALT treatment administered continuously via Medtronic
SynchroMed® II pump within the past 30 days.

- Patient has a life expectancy >6 months as determined by the physician.

- Patient is able to read, understand, and voluntarily sign the IRB-approved informed
consent document prior to the performance of any study-specific procedures.

- Patient is able to understand and complete required assessments.

Exclusion Criteria:

- Patient has a known hypersensitivity to PRIALT or any of its formulation components.

- Patient has a pre-existing history of psychosis.

- Patient has infection at the microinjection site, uncontrolled bleeding diathesis, or
known spinal canal obstruction that impairs circulation of cerebrospinal fluid.

- Patient is being initiated with PRIALT in conjunction with other IT agents.

- Patients with any other concomitant treatment or medical condition that, in the
opinion of the clinician, would render IT administration hazardous.
We found this trial at
55
sites
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Fort Meyers, FL
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Ashland, Oregon 97520
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Ashland, OR
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Ashland, Oregon 97520
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Ashland, OR
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Atlanta, Georgia 30309
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Atlanta, GA
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Atlanta, Georgia 30309
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Atlanta, GA
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Batesville, Arkansas 72501
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Batesville, AR
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Batesville, AR
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Boise, Idaho 83713
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Boise, ID
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Carlasbad, California 92009
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Carlasbad, CA
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Chandler, Arizona 85224
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Chandler, AZ
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Charleston, West Virginia 25301
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Charleston, WV
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Clearwater, Florida 33756
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Clearwater, FL
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Columbus, Ohio 43219
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Columbus, OH
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Cuyahoga Falls, OH
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Elkins Park, Pennsylvania 19027
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Elkins Park, PA
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Greensburg, Pennsylvania 15601
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Greensburg, PA
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Greensburg, Pennsylvania 15601
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Greensburg, PA
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Hackensack, New Jersey 76010
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Hackensack, NJ
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Houston, Texas 77030
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from
Houston, TX
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Houston, Texas 77030
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from
Houston, TX
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Houston, Texas 77030
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mi
from
Houston, TX
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Huntington, West Virginia 25702
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Huntington, WV
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Huntsville, Alabama 35801
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Huntsville, AL
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9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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La Jolla, CA
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Las Vegas, Nevada 89102
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Las Vegas, NV
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Louisville, Kentucky 40204
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Louisville, KY
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Loveland, Colorado 80538
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Loveland, CO
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Madison, WI
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Merritt Island, Florida 32953
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Merritt Island, FL
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Mesa, Arizona 85206
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Mesa, AZ
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Miami, Florida 33145
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Miami, FL
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Miami Gardens, Florida 33169
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Miami Gardens, FL
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Napa, California 94558
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Napa, CA
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Napa, California 94558
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Napa, CA
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Neward, Delaware 19713
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Neward, DE
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Newark, DE
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Paradise Valley, Arizona 85253
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Paradise Valley, AZ
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Phoenix, Arizona
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Phoenix, AZ
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Portland, Oregon 97209
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Portland, OR
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Portland, Oregon 97209
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Portland, OR
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Santa Maria, California 93454
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Santa Maria, CA
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Sarasota, Florida 34232
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Sarasota, FL
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Sarasota, Florida 34238
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Sarasota, FL
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Sherwood, Arkansas 72120
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Sherwood, AR
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Sherwood, Arkansas 72120
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Sherwood, AR
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South Miami, Florida 33143
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South Miami, FL
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Stafford, Virginia 22554
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Stafford, VA
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Tallahassee, Florida 32308
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Tallahassee, FL
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Tampa, Florida 33618
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Tampa, FL
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Utica, New York 13502
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Utica, NY
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Webster, Texas 77598
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Webster, TX
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West Chester, Ohio 45069
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West Chester, OH
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Willoughby Hills, Ohio 44094
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Willoughby Hills, OH
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Winston-Salem, North Carolina 27103
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Winston-Salem, NC
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Winston-Salem, North Carolina 27103
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Winston-Salem, NC
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