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Generated: December 11, 2018

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CLINICAL TRIALS PROFILE FOR PRIALT

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Clinical Trials for Prialt

Trial ID Title Status Sponsor Phase Summary
NCT00047749 Prialt (Ziconotide) In Severe Chronic Pain Completed Elan Pharmaceuticals Phase 3 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.
NCT00076544 Ziconotide Effectiveness and Safety Trial in Patients With Chronic Severe Pain Completed Elan Pharmaceuticals Phase 3 The purpose of this open-label study is to give chronic severe pain patients with existing intrathecal pump systems access to ziconotide.
NCT01373983 Intrathecal Bolus Doses of Ziconotide Completed University Hospital, Linkoeping Phase 4 The purpose of this study is to evaluate if the effect of ziconotide can be tested by intrathecal bolus doses.
NCT01888120 Patient Registry of Intrathecal Ziconotide Management(PRIZM) Active, not recruiting Jazz Pharmaceuticals N/A 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.
NCT01992562 Single Shot Intrathecal Ziconotide for Painful Neuropathy or Myelopathy Unknown status Aaron Boster Phase 4 This is a phase 4 study being conducted at the Ohio State University Department of Neurology Multiple Sclerosis Research Program. The purposes of the study is to administer a single shot of intrathecal (injection into the space surrounding the spinal cord via a lumbar puncture or spinal tap) ziconotide as a test dose to patients who have chronic painful myelopathy (pain from spinal cord damage) or painful peripheral neuropathy (pain from nerve damage) that has not responded to other pain medicines. Study Hypothesis: We intend to determine if a single shot trial (SST) of intrathecal (IT) ziconotide will temporarily reduce pain in these patients. In the proposed study, patients will receive two injections, one of which is the ziconotide and one which is a placebo. They will be blinded and not know which order they receive the treatment versus placebo. The results of this clinical trial will provide a focused examination of ziconotide efficacy and safety in patients with painful neuropathies or myelopathies that have not been effectively treated with other pain medications. Moreover, the use of a single shot trial (SST) IT injection in the outpatient setting will provide evidence for application of this technique in outpatient neurological clinical practice, thereby improving access to this specific patient population. Ziconotide is currently FDA approved for this indication and route of administration. Therefore, a study design that improves the feasibility of ziconotide trialing specifically in the neurology clinic (that is, single shot administration) is being used in order to ensure its broader use by neurologists who routinely care for neuropathy and myelopathy patients. Information from this study will also inform future studies of predictors for long term efficacy after pump placement.
NCT03321955 Ziconotide as First-Line IDT Recruiting Albany Medical College Phase 4 The primary objective of this study is to prospectively examine outcomes in 12 patients using ziconotide Intrathecal Drug Therapy(IDT) as first-line monotherapy with the use of an algorithm of slow titration for dosing. The use of Prialt has demonstrated fewer and less serious associated adverse effects as compared to IDT morphine, especially when titrated slowly. We will use an average Numerical Rating Scale as our primary outcome and the Oswestry Disability Index(ODI), Beck Depression Inventory (BDI), Pain Catastrophizing Scale (PCS), Clinical Global Impression of Change Scale including binary satisfaction measures(CGIC), Lawton-Brody Instrumental Activities of Daily Living(IADL) and Short Form-36 as secondary outcome measures.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Prialt

Condition Name

Condition Name for Prialt
Intervention Trials
Pain 2
Patients With Severe Chronic Pain 1
Painful Neuropathy 1
Painful Myelopathy 1
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Condition MeSH

Condition MeSH for Prialt
Intervention Trials
Chronic Pain 2
Pain 1
Bone Marrow Diseases 1
Peripheral Nervous System Diseases 1
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Clinical Trial Locations for Prialt

Trials by Country

Trials by Country for Prialt
Location Trials
United States 82
Sweden 1
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Trials by US State

Trials by US State for Prialt
Location Trials
Ohio 4
New York 4
Pennsylvania 3
Oregon 3
Texas 3
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Clinical Trial Progress for Prialt

Clinical Trial Phase

Clinical Trial Phase for Prialt
Clinical Trial Phase Trials
Phase 4 3
Phase 3 2
N/A 1
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Clinical Trial Status

Clinical Trial Status for Prialt
Clinical Trial Phase Trials
Completed 3
Recruiting 1
Unknown status 1
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Clinical Trial Sponsors for Prialt

Sponsor Name

Sponsor Name for Prialt
Sponsor Trials
Elan Pharmaceuticals 2
Aaron Boster 1
Jazz Pharmaceuticals 1
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Sponsor Type

Sponsor Type for Prialt
Sponsor Trials
Other 3
Industry 3
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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
Colorcon
Boehringer Ingelheim
Baxter
McKinsey
Deloitte
Medtronic
QuintilesIMS
Cantor Fitzgerald

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