Clinical trial · Interventional
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
NCT00996983CI-TRIAL-00065001ZIDONunknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Intractable Pain | — | UNRESOLVED | — |
| Neuropathic Pain | — | UNRESOLVED | — |
| Pain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ziconotide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- A
- interventionNames
- Drug: ziconotide
Primary outcomes (1)
- measure
- Response rate (> 30% reduction in VASPI)
- timeFrame
- 48 hours after completion of titration phase
Secondary outcomes (2)
- measure
- toxicity
- timeFrame
- daily during drug titration, weekly thereafter
- measure
- duration of analgesic response
- timeFrame
- weekly
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.