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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pain Neuropathic Pain Intractable Pain Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

ziconotide

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No