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
Houston, Texas 77030
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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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Fort Meyers, FL
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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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Houston, TX
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Houston, Texas 77030
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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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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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