Intratecal Ziconotide in the treatment of neuropatic pain in cancer patients. A phase II study. - ZIDON

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-005307-26-IT

Enrollment

Registered

2009-06-05

Start date

2009-06-25

Completion date

Unknown

Last updated

2018-02-19

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

Conditions

Neuropatic pain in cancer patients. MedDRA version: 9.1 Level: SOC Classification code 10029104

Interventions

Trade Name: PRIALT*INFUS 1FL 20ML 25MCG/ML Pharmaceutical Form: Solution for injection INN or Proposed INN: Ziconotide Concentration unit: µg microgram(s) Concentration type: equal Concentration numbe

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Diagnosis of malignant tumors; 2. Severe neuropatic pain (VASPI 6 or greater); 3.Pain not responsive to opioids and adjuvant drugs; 4. Age 18 or greater; 5.Performance Status 0-2; Life expectancy greater than 1 month; effective contraception in female patients if the risk of conception exists; 8. Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1.Exposure to experimental drugs in the previous 30 days; 2.Nursing and/or pregnant women; 3. Contraindication of intratecal analgesia (including active infections or disorders in liquor circulation); 4.Brain metastases; 5.INR greater than 2; 6.Contraindication of ziconotide use; 7.Incapacity or refusal to sign the informed consent

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the activity of intratecal ziconotide in terms of control of severe neuropatic pain not responsive to opioids and adjuvant drugs in cancer patients;Secondary Objective: To evaluate the tolerability of intratecal ziconotide in terms of short and long term adverse events. To describe duration of analgesic effect of ziconotide.;Primary end point(s): Analgesic response to ziconotide, defined as an absolute reduction of 30% or greater in median VASPI scale 48 hours after the last dose increasing as compared to initial value (end of tritation), without modifing current systemic analgesic therapy.	—

Measure

Time frame

Main Objective: To evaluate the activity of intratecal ziconotide in terms of control of severe neuropatic pain not responsive to opioids and adjuvant drugs in cancer patients;Secondary Objective: To evaluate the tolerability of intratecal ziconotide in terms of short and long term adverse events. To describe duration of analgesic effect of ziconotide.;Primary end point(s): Analgesic response to ziconotide, defined as an absolute reduction of 30% or greater in median VASPI scale 48 hours after the last dose increasing as compared to initial value (end of tritation), without modifing current systemic analgesic therapy.

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Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026