DRUG
Status
Completed
Phase
Phase 3
Enrollment
220
Locations
44
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Oct 17, 2002
Study start
Aug 2002
Primary completion
Not reported
Study completion
Jun 2003
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: * Patient is able to read, understand, and voluntarily sign the Institutional Review Board (IRB) approved, written informed consent document prior to the performance of any study-specific procedures; * Patient must be male or female at least 18 years of age; * Patient must have severe chronic pain for whom IT therapy is warranted; * Patient must be willing and able to comply with the protocol, and able to maintain the Patient Daily Diary for Opioid Consumption; * Patient must have an implanted programmable SynchroMed® Infusion System in place for the treatment of chronic pain; * Female patients of childbearing age agree to use adequate, appropriate contraceptive methods. Males and their partner(s) of childbearing age must use adequate, appropriate contraceptive methods. Exclusion Criteria: * Patient is pregnant or lactating; * Patient has been on an investigational drug other than ziconotide or device within 30 days prior to the initiation of the study drug; * Patients with a known hypersensitivity (allergy) to ziconotide or any of the excipients (other compounds) in the formulation; * Patient has a condition that would contraindicate the use of IT analgesia, including the presence of infection at the microinfusion injection site (where the needle is inserted in your abdomen to fill the pump with medication), uncontrolled bleeding diathesis (tendency for bleeding) and spinal canal obstruction that impairs circulation of Cerebral Spinal Fluid.
Study locations
44 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
Tennesee Valley Pain Consultants - Center For Pain Management
Huntsville, Alabama, United States
The Pain Center
Northport, Alabama, United States
Outcomes Research International
Tucson, Arizona, United States
The RC Goodman Pain Institute: Clinical Research
Fort Smith, Arkansas, United States
Hot Springs Mercy Pain Clinic
Hot Springs, Arkansas, United States
Innovative Spine Care
Little Rock, Arkansas, United States
Advanced Pain Medicine
Bakersfield, California, United States
Advanced Pain Institute
Duarte, California, United States
UCSD Medical Center, Thornton Hospital
La Jolla, California, United States
Abaci and Massey Pain Center
Los Gatos, California, United States
UCSF Pain Management Center
San Francisco, California, United States
Pain Care Specialists
Colorado Springs, Colorado, United States
Clinical Pharmacology Services, Inc.
Tampa, Florida, United States
Georgia Medical Research Institute
Marietta, Georgia, United States
Rush Presbyterian - St. Luke's Medical Center
Chicago, Illinois, United States
University of Kentucky, Dept Anesthesiology
Lexington, Kentucky, United States
Johns Hopkins Hospital, Division of Pain Management
Baltimore, Maryland, United States
Arnold Pain Management
Boston, Massachusetts, United States
Edina Medical Pain Center
Edina, Minnesota, United States
Research Medical Center - Pain Institute
Kansas City, Missouri, United States
Yellowstone Medical Center East
Billings, Montana, United States
Huntington Center for Pain Treatment
Huntington, New York, United States
Weill Medical College of Cornell University
New York, New York, United States
Medical Pain Management of Central NY
Syracuse, New York, United States
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Ziconotide.
NCT IDStudyPhase / statusEnrollmentUpdated
Evaluating the Effectiveness of AIT in the Treatment of Pain Related to Pancreatic Cancer
Clinique Bizet · Pancreatic Cancer Pain · Intrathecal Analgesic
Not applicable
Not yet recruiting
40
2026-07
Intrathecal Ziconotide in Chemotherapy Induced Peripheral Neuropathy
Christian Hospital Northeast Northwest · Chemotherapy Induced Peripheral Neuropathy (CIPN)
Not applicable
Not yet recruiting
24
2026-03
OP2C : Prialt® Observatory in Clinical Practice
Institut Cancerologie de l'Ouest · Refractory Pain
Not applicable
Recruiting
300
2025-08
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.