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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00996983

Acronym

ZIDON

Enrollment

Registered

2009-10-16

Start date

2009-09-30

Completion date

2024-12-31

Last updated

2023-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Intractable Pain, Neuropathic Pain, Pain

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.

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.

Interventions

DRUGziconotide

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Response rate (> 30% reduction in VASPI)	48 hours after completion of titration phase

Secondary

Measure	Time frame
toxicity	daily during drug titration, weekly thereafter
duration of analgesic response	weekly

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026