This trial is active, not recruiting.

Conditions pain, neuropathic pain, intractable pain, cancer
Treatment ziconotide
Phase phase 2
Sponsor National Cancer Institute, Naples
Start date September 2009
End date July 2016
Trial size 16 participants
Trial identifier NCT00996983, EudraCT number: 2008-005307-26, ZIDON


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
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

Primary Outcomes

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

Secondary Outcomes

time frame: daily during drug titration, weekly thereafter
duration of analgesic response
time frame: weekly

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Phase II Study of Intrathecal Ziconotide for the Treatment of Neuropathic Pain in Patients With Cancer
Principal investigator Arturo Cuomo, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by National Cancer Institute, Naples.