UnknownPhase 2

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

Italy16 participantsStarted 2009-09

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Response rate (> 30% reduction in VASPI)

Timeframe: 48 hours after completion of titration phase

Trial details

NCT IDNCT00996983

SponsorNational Cancer Institute, Naples

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12

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