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Safety and Activity Study of Intrathecally Administered Ziconotide for Neuropathic Pain in Patients With Cancer (ZIDON)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00996983
Recruitment Status : Active, not recruiting
First Posted : October 16, 2009
Last Update Posted : March 29, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Neuropathic pain is difficult to control because it is only partially sensitive to opioid analgesics, and requires the addition of other therapies such as antidepressants and epileptics. Ziconotide is a drug that is used to treat neuropathic pain in patients who have had inadequate pain control with prior combination of medicines.

Condition or disease Intervention/treatment Phase
Pain Neuropathic Pain Intractable Pain Cancer Drug: ziconotide Phase 2

Detailed Description:
The purpose of this study is to evaluate the effects and the tolerability of intrathecal ziconotide in cancer patients suffering from severe neuropathic pain not controlled by previous therapies.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Intrathecal Ziconotide for the Treatment of Neuropathic Pain in Patients With Cancer
Study Start Date : September 2009
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Ziconotide
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: A Drug: ziconotide
intrathecal ziconotide starting at 2.4 micrograms/day, with titration daily to achieve adequate pain control up to maximum dose of 21.6 micrograms/day


Outcome Measures

Primary Outcome Measures :
  1. Response rate (> 30% reduction in VASPI) [ Time Frame: 48 hours after completion of titration phase ]

Secondary Outcome Measures :
  1. toxicity [ Time Frame: daily during drug titration, weekly thereafter ]
  2. duration of analgesic response [ Time Frame: weekly ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of neoplasm
  • Neuropathic pain level VASPI > or = 6 (0-10 scale)
  • Inadequate pain relief with opioid analgesics and adjuvants
  • Age > or = 18 years
  • Performance status ECOG 0-2
  • Life expectancy at least one month
  • Adequate contraception in women of child-bearing potential
  • Signed Informed Consent

Exclusion Criteria:

  • Use of experimental drugs within previous 30 days
  • Pregnancy or lactation
  • Contraindication to the use of intrathecal analgesics, including active infection or conditions that could alter the circulation of cerebrospinal fluid
  • Presence of cerebral metastasis
  • INR > 2
  • Contraindication to the use of ziconotide
  • Unable or unwilling to provide informed consent
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00996983


Locations
Italy
Istituto Nazionale dei Tumori , Unita Terapia Antalgica
Napoli, Italy
Sponsors and Collaborators
National Cancer Institute, Naples
Investigators
Principal Investigator: Arturo Cuomo, M.D. NCI Naples, Division of Pain Therapy
Principal Investigator: Gennaro Russo, M.D. NCI Naples, Division of Pain Therapy
Principal Investigator: Alessandro Morabito, M.D. NCI Naples, Clinical Trials Unit
More Information

Responsible Party: National Cancer Institute, Naples
ClinicalTrials.gov Identifier: NCT00996983     History of Changes
Other Study ID Numbers: ZIDON
EudraCT number: 2008-005307-26
First Posted: October 16, 2009    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Neuralgia
Pain, Intractable
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Ziconotide
omega-Conotoxins
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents