DRUG
Ziconotide Effectiveness and Safety Trial in Patients With Chronic Severe Pain
Status
Completed
Phase
Phase 3
Enrollment
300
Locations
65
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
The purpose of this open-label study is to give chronic severe pain patients with existing intrathecal pump systems access to ziconotide.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Feb 4, 2004
Study start
Feb 2004
Primary completion
Mar 2005
Study completion
Not reported
Results posted
Not reported
Registry updated
Dec 14, 2015
Outcomes
What the study measures.
Primary outcomes
Not reported in the indexed record.
Secondary outcomes
Not reported in the indexed record.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: * Each patient must have chronic severe pain of malignant or nonmalignant etiology with inadequate pain relief from or intolerance to conventional therapy. * Each patient must have a predicted life expectancy of greater than or equal to 6 weeks relative to baseline. * Each patient must be able to respond to the Visual Analog Scale of Pain Intensity (VASPI). * Each patient must have an implanted programmable SynchroMed infusion device or a CADD-Micro external programmable infusion device and spinal catheter (hereafter "IT pump and spinal catheter") prior to enrollment into this trial. (If a patient has an external pump, the Investigator must ensure that the patient is at a low risk for infection and that the patient is capable of maintaining good personal hygiene. The Investigator must have demonstrated the ability to successfully manage patients with external pumps prior to enrolling a patient in this trial.) * Each patient must be at least 18 years of age. * Each patient must be competent to give written informed consent and has given written informed consent prior to performance of any study-related procedures. Reasonable accommodation of visually impaired patients will be allowed. * Each patient is willing and able to comply with the protocol requirements. * Each female patient of childbearing potential must agree to use adequate contraceptive methods while on PRIALT as determined by the Investigator. Exclusion Criteria: * Presence of pregnancy or lactation. * Participation in another investigational drug or device trial within the preceding 30 days. * Presence of known hypersensitivity to PRIALT or any of its components. * Presence of any contraindication to continued IT therapy (for example, infection at the pump or catheter externalization site, uncontrolled bleeding diathesis, spinal canal obstruction that impairs cerebrospinal fluid \[CSF\] circulation, or patient and caregiver inability to manage and protect the IT pump and spinal catheter system and return for clinic follow up visits). * Presence of any condition (for example, psychosis, severe depression or suicidal ideation, homicidality, somatization disorder, active substance abuse, cognitive deficits, dementia or other serious medical or psychiatric condition) that in the Investigator's opinion precludes the patient's ability to participate in this study.
Study locations
65 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
Alabama Pain Center
Huntsville, Alabama, United States
Center for Pain Management
Huntsville, Alabama, United States
Otto Uhrik, MD
Sun City West, Arizona, United States
Outcomes Research International
Tucson, Arizona, United States
The RC Goodman Pain Institute
Fort Smith, Arkansas, United States
Innovative Spine Care
Little Rock, Arkansas, United States
Shreenath Clinical Services
Beverly Hills, California, United States
Advanced Pain Institute
Duarte, California, United States
Shreenath Clinical Services
Lake Forest, California, United States
Shreenath Clinical Services
Long Beach, California, United States
Bay Area Pain Center
Los Gatos, California, United States
Northridge Surgery & Pain Management Center
Northridge, California, United States
Pacific Pain Medicine Consultants
Oceanside, California, United States
Pacific Pain Treatment Centers
San Francisco, California, United States
Galileo Surgery Center
San Luis Obispo, California, United States
Pain Relief Center of Colorado
Arvada, Colorado, United States
Pain Care Specialists
Colorado Springs, Colorado, United States
Rocky Mountain Clinical Research
Golden, Colorado, United States
Comprehensive Pain and Headache Treatment Centers, LLC
Derby, Connecticut, United States
Florida Institute of Medical Research
Jacksonville, Florida, United States
Space Coast Pain Institute
Merritt Island, Florida, United States
West Gables Rehabilitation Hospital
Miami, Florida, United States
Sarasota Pain Associates
Sarasota, Florida, United States
Clinical Pharmacology Services
Tampa, Florida, United States
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Ziconotide.
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Not applicable
Not yet recruiting
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2026-07
Intrathecal Ziconotide in Chemotherapy Induced Peripheral Neuropathy
Christian Hospital Northeast Northwest · Chemotherapy Induced Peripheral Neuropathy (CIPN)
Not applicable
Not yet recruiting
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2026-03
OP2C : Prialt® Observatory in Clinical Practice
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Ziconotide for Non-cancer Pain by Intrathecal Administration
ESTEVE Pharmaceuticals SAS · Pain, Chronic
Not applicable
Recruiting
85
2025-02
Safety and Activity Study of Intrathecally Administered Ziconotide for Neuropathic Pain in Patients With Cancer
National Cancer Institute, Naples · Pain · Neuropathic Pain
Phase 2
Unknown
16
2023-03
Ziconotide as First-Line IDT
Albany Medical College · Neuropathic Pain
Phase 4
Completed
13
2021-01
Intrathecal Ziconotide Antalgic Efficacy for Severe Refractory Neuropathic
Hospices Civils de Lyon · Severe Refractory Neuropathic Pain · Spinal Cord Lesions
Phase 3
Unknown
44
2019-05
Patient Registry of Intrathecal Pain Management in Europe for Prialt (Ziconotide Intrathecal Infusion) and Alternative Drugs for the Management of Severe, Chronic Pain.
Eisai Limited · Pain Management · Severe Chronic Pain
Not applicable
Completed
219
2018-10
Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.