DRUG
ziconotide
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
Safety and Activity Study of Intrathecally Administered Ziconotide for Neuropathic Pain in Patients With Cancer
Status
Unknown
Phase
Phase 2
Enrollment
16
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Full 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
Treatment arms and agents.
Timeline
From registration to results.
First posted
Oct 16, 2009
Study start
Sep 2009
Primary completion
Dec 2024
Study completion
Dec 2024
Results posted
Not reported
Registry updated
Mar 24, 2023
Outcomes
What the study measures.
Primary outcomes
Response rate (> 30% reduction in VASPI)
Time frame · 48 hours after completion of titration phase
Secondary outcomes
toxicity
Time frame · daily during drug titration, weekly thereafter
duration of analgesic response
Time frame · weekly
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
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 locations
1 registered sites.
Italy. Showing up to 24 locations stored in the fast local snapshot.
Istituto Nazionale dei Tumori , Unita Terapia Antalgica
Naples, Italy
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Ziconotide.
NCT IDStudyPhase / statusEnrollmentUpdated
Evaluating the Effectiveness of AIT in the Treatment of Pain Related to Pancreatic Cancer
Clinique Bizet · Pancreatic Cancer Pain · Intrathecal Analgesic
Not applicable
Not yet recruiting
40
2026-07
Intrathecal Ziconotide in Chemotherapy Induced Peripheral Neuropathy
Christian Hospital Northeast Northwest · Chemotherapy Induced Peripheral Neuropathy (CIPN)
Not applicable
Not yet recruiting
24
2026-03
OP2C : Prialt® Observatory in Clinical Practice
Institut Cancerologie de l'Ouest · Refractory Pain
Not applicable
Recruiting
300
2025-08
Ziconotide for Non-cancer Pain by Intrathecal Administration
ESTEVE Pharmaceuticals SAS · Pain, Chronic
Not applicable
Recruiting
85
2025-02
Ziconotide as First-Line IDT
Albany Medical College · Neuropathic Pain
Phase 4
Completed
13
2021-01
Intrathecal Ziconotide Antalgic Efficacy for Severe Refractory Neuropathic
Hospices Civils de Lyon · Severe Refractory Neuropathic Pain · Spinal Cord Lesions
Phase 3
Unknown
44
2019-05
Patient Registry of Intrathecal Pain Management in Europe for Prialt (Ziconotide Intrathecal Infusion) and Alternative Drugs for the Management of Severe, Chronic Pain.
Eisai Limited · Pain Management · Severe Chronic Pain
Not applicable
Completed
219
2018-10
Single Shot Intrathecal Ziconotide for Painful Neuropathy or Myelopathy
Aaron Boster · Painful Myelopathy · Painful Neuropathy
Phase 4
Withdrawn
0
2018-09
Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.