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NCT00996983 Clinical Trial

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

Pain Clinical Trial

— ZIDON  

Official title:
Phase II Study of Intrathecal Ziconotide for the Treatment of Neuropathic Pain in Patients With Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00996983
Other study ID # ZIDON
Secondary ID EudraCT number:
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date September 2009
Est. completion date December 2024

Study information
Verified date March 2023
Source National Cancer Institute, Naples
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 16
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Italy Istituto Nazionale dei Tumori , Unita Terapia Antalgica Napoli

Sponsors (1)
Lead Sponsor Collaborator
National Cancer Institute, Naples

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Response rate (> 30% reduction in VASPI) 48 hours after completion of titration phase
Secondary toxicity daily during drug titration, weekly thereafter
Secondary duration of analgesic response weekly
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