CLINICAL TRIALS PROFILE FOR PRIALT
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All Clinical Trials for PRIALT
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00047749 ↗ | Prialt (Ziconotide) In Severe Chronic Pain | Completed | Elan Pharmaceuticals | Phase 3 | 2002-08-01 | 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 | 2004-02-01 | 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 | 2011-08-01 | 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) | Completed | Jazz Pharmaceuticals | 2013-07-01 | 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| NCT01992562 ↗ | Single Shot Intrathecal Ziconotide for Painful Neuropathy or Myelopathy | Withdrawn | Aaron Boster | Phase 4 | 2014-01-01 | This is a phase 4 study being conducted at the Ohio State University Department of Neurology Multiple Sclerosis Research Program. The purpose 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. |
| NCT03321955 ↗ | Ziconotide as First-Line IDT | Completed | Albany Medical College | Phase 4 | 2016-11-03 | 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 | >Start Date | >Summary |
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