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Patient Registry of Intrathecal Ziconotide Management(PRIZM) (PRIZM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01888120
Recruitment Status : Completed
First Posted : June 27, 2013
Last Update Posted : March 16, 2017
Sponsor:
Information provided by (Responsible Party):
Jazz Pharmaceuticals

Brief Summary:
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.

Condition or disease Intervention/treatment
Patients With Severe Chronic Pain Drug: Ziconotide

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Study Type : Observational [Patient Registry]
Actual Enrollment : 93 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 18 Months
Official Title: 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
Study Start Date : July 2013
Actual Primary Completion Date : January 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain
Drug Information available for: Ziconotide

Group/Cohort Intervention/treatment
Severe Chronic Pain Drug: Ziconotide



Primary Outcome Measures :
  1. The effectiveness of PRIALT therapy for the management of severe chronic pain as evidenced by change in patient-reported pain intensity from baseline to 12 weeks after enrollment [ Time Frame: 12 Weeks ]

Secondary Outcome Measures :
  1. Evaluate the following from the patient's perspective via patient reported outcomes (PROs) [ Time Frame: From week 12, every 3 months up to month 18 ]
  2. Evaluate the patient's global impression of change (PGIC) with PRIALT treatment [ Time Frame: From week 12, every 3 months up to month 18 ]
  3. Evaluate changes in concomitant pain medication use [ Time Frame: From week 12, every 3 months up to month 18 ]
  4. Evaluate long-term safety and tolerability data, including incidence and severity of adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: From week 12, every 3 months up to month 18 ]
  5. The use of PRIALT in current clinical practice including dose at initiation, titration speed, effective dose, duration of treatment effect, use of other pain medications, etc. [ Time Frame: From week 12, every 3 months up to month 18 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Up to 140 patients will be enrolled at approximatley 50 sites in the United States.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01888120


Locations
Show Show 43 study locations
Sponsors and Collaborators
Jazz Pharmaceuticals
Investigators
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Study Director: I-Zu Huang, MD Jazz Pharmaceuticals
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jazz Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01888120    
Other Study ID Numbers: 13-001
First Posted: June 27, 2013    Key Record Dates
Last Update Posted: March 16, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Ziconotide
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents