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 range

18 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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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