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

Phase 2

Active, not recruiting

• Conditions: Pain; Neuropathic Pain; Intractable Pain; Cancer
• Interventions: Drug: ziconotide

• Registration Number: NCT00996983
• Lead Sponsor: National Cancer Institute, Naples

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.

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-30
• Study First Submitted QC: 2009-10-15
• Study First Posted: 2009-10-16
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-23
• Last Update Posted: 2023-03-24
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 16

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	ziconotide	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
toxicity	daily during drug titration, weekly thereafter
duration of analgesic response	weekly

Trial Locations

Locations (1)

Istituto Nazionale dei Tumori , Unita Terapia Antalgica; 🇮🇹 Napoli, Italy