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CompletedNCT00047749Updated Dec 14, 2015

Prialt (Ziconotide) In Severe Chronic Pain

A Phase 3 interventional study of Prialt (ziconotide) in Pain, sponsored by Elan Pharmaceuticals. Completed at 44 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-12-14.

Sponsored by Elan Pharmaceuticals · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
220
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

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.

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Conditions studied

  • Pain

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Keywords

  • pain
  • ziconotide
  • Prialt
  • intrathecal
  • Synchromed
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In context

Chronic Pain

2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.

This study's enrollment of 220 is above the median of 60 across 2,161 interventional studies indexed under Chronic Pain.

Browse Chronic Pain studies →

Lead sponsor

Elan Pharmaceuticals is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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.
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Double
Enrollment
220 participants

Interventions

  • DrugPrialt (ziconotide)
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Study locations

44 sites
  • Tennesee Valley Pain Consultants - Center For Pain Management
    Huntsville, Alabama 35801, United States
  • The Pain Center
    Northport, Alabama 35476, United States
  • Outcomes Research International
    Tucson, Arizona 85711, United States
  • The RC Goodman Pain Institute: Clinical Research
    Fort Smith, Arkansas 72901, United States
  • Hot Springs Mercy Pain Clinic
    Hot Springs, Arkansas 71913, United States
  • Innovative Spine Care
    Little Rock, Arkansas 72205, United States
  • Advanced Pain Medicine
    Bakersfield, California 93311, United States
  • Advanced Pain Institute
    Duarte, California 91010, United States
  • UCSD Medical Center, Thornton Hospital
    La Jolla, California 92037, United States
  • Abaci and Massey Pain Center
    Los Gatos, California 95032, United States
  • UCSF Pain Management Center
    San Francisco, California 94143-1654, United States
  • Pain Care Specialists
    Colorado Springs, Colorado 80907, United States
  • Clinical Pharmacology Services, Inc.
    Tampa, Florida 33617, United States
  • Georgia Medical Research Institute
    Marietta, Georgia 30060, United States
  • Rush Presbyterian - St. Luke's Medical Center
    Chicago, Illinois 60612, United States
  • University of Kentucky, Dept Anesthesiology
    Lexington, Kentucky 40536, United States
  • Johns Hopkins Hospital, Division of Pain Management
    Baltimore, Maryland 21205, United States
  • Arnold Pain Management
    Boston, Massachusetts 02215, United States
  • Edina Medical Pain Center
    Edina, Minnesota 55435, United States
  • Research Medical Center - Pain Institute
    Kansas City, Missouri 64132, United States
  • Yellowstone Medical Center East
    Billings, Montana 59101, United States
  • Huntington Center for Pain Treatment
    Huntington, New York 11743, United States
  • Weill Medical College of Cornell University
    New York, New York 10021, United States
  • Medical Pain Management of Central NY
    Syracuse, New York 13210, United States
  • Center For Clinical Research
    Winston-Salem, North Carolina 27103, United States
  • The Cleveland Clinic Foundation
    Cleveland, Ohio 44195, United States
  • Pain Institute of Tulsa
    Tulsa, Oklahoma 74137, United States
  • Pain Consultants of Oregon
    Eugene, Oregon 97401, United States
  • Legacy Holladay Park Medical Center
    Portland, Oregon 97232, United States
  • Penn State University Hospital
    Hershey, Pennsylvania 17033, United States
  • Allegheny General Hospital
    Pittsburgh, Pennsylvania 15212, United States
  • Advanced Clinical Concepts
    Temple, Pennsylvania 19560, United States
  • Neurosurgery Foundation
    Providence, Rhode Island 02903, United States
  • MUSC, Neurological Surgery
    Charleston, South Carolina 29425, United States
  • Methodist Comprehensive Pain Institute
    Memphis, Tennessee 38104, United States
  • Clinical Research Associates, Inc.
    Nashville, Tennessee 37203, United States
  • University of Texas M.D. Anderson Cancer Center
    Houston, Texas 77030, United States
  • Texas Tech University HSC
    Lubbock, Texas 79430, United States
  • Consultants in Pain Research
    San Antonio, Texas 78217, United States
  • Alpine Pain and Addiction Medicine
    Salt Lake City, Utah 84107, United States
  • Advanced Pain Management and Rehabilitation
    Virginia Beach, Virginia 23454, United States
  • University of Washington Medical Center - Pain Center
    Seattle, Washington 98195, United States
  • Center for Pain Relief
    Charleston, West Virginia 25301, United States
  • Cardinal Clinical Research Center
    Cudahy, Wisconsin 53110, United States
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 14, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00047749
Lead sponsor
Elan Pharmaceuticals
First posted
Oct 17, 2002
Start date
Aug 2002
Completion
Jun 2003
Last update
Dec 14, 2015
View the source record on ClinicalTrials.gov ↗

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